The Effects of Combining Web-Based eHealth With Telephone Nurse Case Management for Pediatric Asthma Control: A Randomized Controlled Trial

Background Asthma is the most common pediatric illness in the United States, burdening low-income and minority families disproportionately and contributing to high health care costs. Clinic-based asthma education and telephone case management have had mixed results on asthma control, as have eHealth programs and online games. Objectives To test the effects of (1) CHESS+CM, a system for parents and children ages 4–12 years with poorly controlled asthma, on asthma control and medication adherence, and (2) competence, self-efficacy, and social support as mediators. CHESS+CM included a fully automated eHealth component (Comprehensive Health Enhancement Support System [CHESS]) plus monthly nurse case management (CM) via phone. CHESS, based on self-determination theory, was designed to improve competence, social support, and intrinsic motivation of parents and children. Methods We identified eligible parent–child dyads from files of managed care organizations in Madison and Milwaukee, Wisconsin, USA, sent them recruitment letters, and randomly assigned them (unblinded) to a control group of treatment as usual plus asthma information or to CHESS+CM. Asthma control was measured by the Asthma Control Questionnaire (ACQ) and self-reported symptom-free days. Medication adherence was a composite of pharmacy refill data and medication taking. Social support, information competence, and self-efficacy were self-assessed in questionnaires. All data were collected at 0, 3, 6, 9, and 12 months. Asthma diaries kept during a 3-week run-in period before randomization provided baseline data. Results Of 305 parent–child dyads enrolled, 301 were randomly assigned, 153 to the control group and 148 to CHESS+CM. Most parents were female (283/301, 94%), African American (150/301, 49.8%), and had a low income as indicated by child’s Medicaid status (154/301, 51.2%); 146 (48.5%) were single and 96 of 301 (31.9%) had a high school education or less. Completion rates were 127 of 153 control group dyads (83.0%) and 132 of 148 CHESS+CM group dyads (89.2%). CHESS+CM group children had significantly better asthma control on the ACQ (d = –0.31, 95% confidence limits [CL] –0.56, –0.06, P = .011), but not as measured by symptom-free days (d = 0.18, 95% CL –0.88, 1.60, P = 1.00). The composite adherence scores did not differ significantly between groups (d = 1.48%, 95% CL –8.15, 11.11, P = .76). Social support was a significant mediator for CHESS+CM’s effect on asthma control (alpha = .200, P = .01; beta = .210, P = .03). Self-efficacy was not significant (alpha = .080, P = .14; beta = .476, P = .01); neither was information competence (alpha = .079, P = .09; beta = .063, P = .64). Conclusions Integrating telephone case management with eHealth benefited pediatric asthma control, though not medication adherence. Improved methods of measuring medication adherence are needed. Social support appears to be more effective than information in improving pediatric asthma control. Trial Registration Clinicaltrials.gov NCT00214383; http://clinicaltrials.gov/ct2/show/NCT00214383 (Archived by WebCite at http://www.webcitation.org/68OVwqMPz)


INTRODUCTION 2a) In INTRODUCTION: Scientific background and explanation of rationale 2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Poor control of pediatric asthma affects low-income and minority children disproportionately and contributes to more than 14 million lost school days and three million lost parental workdays per year.
[22] Daily controller medications can manage even severe asthma, [23] but adherence is low, especially for the underserved.
The project was carried out with a University of Wisconsin-based team of educators, pharmacists, and nurse practitioners specializing in asthma rather than with staff from the five managed care organizations from which participants were recruited. University of Wisconsin-based nurse practitioners also monitored the progress of recruitment. The project director monitored the discussion group within CHESS to ensure that calls for help were rapidly addressed and that inaccurate information was not shared.
The authors, therefore, hypothesized that a parent-focused intervention that integrates monthly telephone nurse case management with a comprehensive, interactive asthma eHealth program could improve asthma control and medication adherence. We surmised that these effects would be mediated by social support, self-efficacy, and asthma information competence. This article reports the results of a randomized control trial funded by the National Institute for Nursing Research.

2a-ii) Scientific background, rationale: What is known about the (type of) system
Scientific background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/diagnoses, if appropiate), motivation for the study, i.e. what are the reasons for and what is the context for this specific study, from which stakeholder viewpoint is the study performed, potential impact of findings [2]. Briefly justify the choice of the comparator.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Asthma education programs, with their low participation rates, have had mixed results.
[23] Nurse case management can reduce asthma-related emergency care and hospitalization costs, but is expensive. [25,26] Child-focused, webbased asthma education and games (eHealth) have improved knowledge, asthma control, and medication adherence in the short run. [27,28,29] However, parents tend to over-estimate their child's medication-taking skills and actual adherence. [30] This suggests that parental involvement might be beneficial for managing pediatric asthma. Integrating phone-based clinician care into asthma eHealth programs for adults has shown significant promise in behavioral and asthma outcomes.
[31] Interventions based on self determination theory (SDT) [32] and self-efficacy [33] provide information, social support, and skill-building tools for self-managing the disease. These interventions, which aim to increase confidence, competence, relatedness, and autonomous motivation, have been used successfully in asthma education programs. [28,29,32,34] However, the factors associated with these theories have not been tested for their mediational effects on adherence to controller medications or asthma control. Understanding this is important for developing an asthma eHealth system that balances the various functions-information, social support, and skill-building-to the best effect for children and their parents."

2b) In INTRODUCTION: Specific objectives or hypotheses
Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The authors, therefore, hypothesized that a parent-focused intervention that integrates monthly telephone nurse case management with a comprehensive, interactive asthma eHealth program could improve asthma control and medication adherence. We surmised that these effects would be mediated by social support, self-efficacy, and asthma information competence. This article reports the results of a randomized control trial funded by the National Institute for Nursing Research."

3a) Description of trial design (such as parallel, factorial) including allocation ratio
Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This article reports the results of a randomized control trial funded by the National Institute for Nursing Research.
"Participants were equally randomized according to their MCO and then blocked by severity and, after the intake at MCO 5, by Medicaid status.
[41]" 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Originally children were identified through the healthcare utilization and pharmacy claim databases at four managed care organizations (MCOs 1-4) and the Wisconsin Medicaid Program (WMP) from one urban-rural county (Dane County, which is also the home of the University of Wisconsin-Madison) and seven surrounding rural counties (Columbia, Dodge, Green, Iowa, Jefferson, Rock, and Sauk). MCO 5 in Milwaukee was added after it became clear that MCOs 1-4 could not produce enough subjects with poorly control asthma. MCO 5 served an entirely Medicaid population in Milwaukee County and had the state's highest rates of asthma-related emergency department visits and overnight hospital stays. [40]"

3b-i) Bug fixes, Downtimes, Content Changes
Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 3b-i? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "No major bug fixes or down times occurred. Annual updates of asthma-related content were made over the course of the study."

4a) Eligibility criteria for participants
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Eligible subjects included parents or other adults functioning as parents, such as grandmothers, who were able to read at a sixth-grade level and had children ages 4-12 with a diagnosis of asthma (ICD-9 493) or wheezing (ICD-9786.07); a prescribed asthma controller medication; and poor medication adherence, defined as having missed more than one medication refill or having an emergency department visit or hospitalization because of poor asthma control."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-i? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable.

4a-ii) Open vs. closed, web-based vs. face-to-face assessments:
Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Recruitment was initiated by a letter from the MCO or WMP to parents of studyeligible patients with an opt-in or an opt-out card regarding a phone call from the study nurse, depending on the organization's IRB policies.
[41] Recruiters screened for eligibility, described the study (as a comparison of two approaches to asthma control) and its risks and benefits, and scheduled an intake interview for people who agreed to participate." 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-iii? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Potential subjects were informed of (1) the nature and purpose of the study, (2) the financial compensation offered ($35 for completing each of four surveys and providing four spirometry readings), (3) the types of data to be collected from claims records, surveys, and computer-use tracking, (4) the intervention to be given to the experimental group, (5) the nature and reasons for random assignment, (6) the measures used to insure the confidentiality of data collected, (7) the timeline of the study, (8) the duration of the study (12 months, to capture the seasonality of asthma), and (9) the University of Wisconsin-Maditon being the research organization for the project. Consent was documented by obtaining signed, IRB-approved consent forms containing all of the above information. The consent forms were kept in a locked file at CHESS. Intake appointments assessed parental ability to read at a sixth-grade level by asking parents to read aloud the consent letter. The appointments also included recording medications and doses, a spirometry test, and the child's asthma history. A researcher administered a pre-test survey with training on completing the asthma diary and provided individualized asthma education as needed. Regardless of study arm, CMs notified MCO staff about children with uncontrolled asthma for further evaluation."

4b) Settings and locations where the data were collected
Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Parents and children participated in a pre-randomization intake appointment with a study CM at asthma clinics associated with MCOs 1-4 and, in MCO 5, at a community center." "All participants . . . received mailed surveys at 3, 6, 9, and 12 months." "Parents and children returned to the clinic or community center for an exit interview that included taking the same measures used at the intake appointment." 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise. subitem not at all important essential Does your paper address subitem 4b-ii? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Subjects were informed of . . . . (9) the University of Wisconsin--Madison being the research organization for the project."

5)
The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-i? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The project was carried out with a University of Wisconsin-based team of educators, pharmacists, and nurse practitioners specializing in asthma."

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-ii? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The CM received tools to schedule monthly phone calls with the parent, view parents' "Asthma Coach" entries, enter phone call notes, send and receive CM mail to and from the parent, and a "prescription pad" to place CHESS resources on the parent's HomePage. [38] Monthly CM calls to the parent assessed the child's asthma, medication adherence, and psychosocial challenges and provided relevant education and support. Upon completing a call, the CM entered notes in the CM toolbox and then sent the parent a summary via CMail with links to salient CHESS resources, which appeared on the parents' CHESS HomePage, as shown in Figure 2.[38] These features were designed with user input for content and usability. For a more complete description of the CHESS asthma module and its development, see Wise et al., 2007.[38]"

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-iii? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "No major bug fixes or downtimes occurred. Annual updates of asthma-related content were made over the course of the study. Otherwise, no major modifications were made to the system."

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study for all primary outcome variables.
Robert P. Hawkins, PhD, contributed to the design of the research protocols and CHESS program content, and to data analysis and interpretation.
Jee-Seon Kim, PhD designed and conducted the mediational analyses." Acknowledgments "Robert Lemanske, MD, Marcus Cohen, MD, and Donald Bukstein, MD for reviewing the CHESS asthma program, and Christine Sorkness, PhD, for reviewing the CHESS asthma module content."

5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing flowcharts of the algorithms used
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.

Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The module is available at https://chess.wisc.edu/asthmamobile/. The code name is "uwmadison" and the password is "testing." Screen shorts of the program are available on request."

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The module is available at https://chess.wisc.edu/asthmamobile/. The code name is "uwmadison" and the password is "testing." Screen shorts of the program are available on request."

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The module is available at https://chess.wisc.edu/asthmamobile/. The code name is "uwmadison" and the password is "testing." Screen shorts of the program are available on request."

Does your paper address subitem 5-viii? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study used successfully in asthma education programs. [28,29,32,34]." "The CM received tools to schedule monthly phone calls with the parent, view parents' "Asthma Coach" entries, enter phone call notes, send and receive CM mail to and from the parent, and a "prescription pad" to place CHESS resources on the parent's HomePage. [38] Monthly CM calls to the parent assessed the child's asthma, medication adherence, and psychosocial challenges and provided relevant education and support. Upon completing a call, the CM entered notes in the CM toolbox and then sent the parent a summary via CMail with links to salient CHESS resources, which appeared on the parents' CHESS HomePage, as shown in Figure 2.[38] These features were designed with user input for content and usability. For a more complete description of the CHESS asthma module and its development, see Wise et al., 2007.[38]" Also please see previous answer.

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-ix? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "All users were instructed to use CHESS whenever they wished. No minimum expectations were placed on users."

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The CM received tools to schedule monthly phone calls with the parent, view parents' "Asthma Coach" entries, enter phone call notes, send and receive CM mail to and from the parent, and a "prescription pad" to place CHESS resources on the parent's HomePage.
[38] Monthly CM calls to the parent assessed the child's asthma, medication adherence, and psychosocial challenges and provided relevant education and support. Upon completing a call, the CM entered notes in the CM toolbox and then sent the parent a summary via CMail with links to salient CHESS resources, which appeared on the parents' CHESS HomePage, as shown in Figure 2.[38]"

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "All users were instructed to use CHESS whenever they wished. No minimum expectations were placed on users."

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as standalone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability.

Does your paper address subitem 5-xii? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The CHESS+CM group received a 45-minute training session. Laptop computers, land phone lines, and Internet service were provided, as needed. MCOs 1-4 and WMP participants received one-on-one training at home on an Internet-enabled computer with the live CHESS program. MCO 5 participants received group training at the community center where they had had their intake interview. Because that center lacked Internet access and most participants borrowed study laptops, training on using the laptop and CHESS was guided by an interactive CD." 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Asthma control was measured via two self-reports collected at baseline and at 3, 6, 9, and 12 months. Juniper's Asthma Control Questionnaire ACQ® was administered orally at the intake and exit interviews, and self-administered via mailed surveys for the intervening time points.
[42] This well-validated, six-item, seven-point Likert scale measured daytime and nocturnal symptoms, missed school, and rescue medication use over the previous seven days. [42] Lower scores indicated better asthma control. Scales were created as a mean of all items. Surveys with missing ACQ® items were not calculated and counted as missing data. Symptom-free days were calculated from two-week diaries as the absence of asthma-related nighttime awakenings, daytime symptoms, bronchodilator use, unscheduled physician visits, or school absences that were shown to detect difference over time.
[43] The study included a run-in period for three weeks before randomization during which participants kept asthma diaries that were used to collect baseline data on symptom-free days.
Adherence to asthma controller medications was measured as the mean composite score from self-reported two-week asthma diaries at baseline, 3, 6, 9, and 12 months,[43] and the medication-possession ratio calculated from MCO and WMP pharmacy claims data as the actual versus expected prescription refill rate for each participant's prescription.
Social support, self-efficacy, and information competence were adapted from five-point Likert scales used successfully in prior CHESS studies.
[35] The sixitem social-support scale assessed the availability and reliability of social, emotional, and instrumental support. The six-item self-efficacy scale assessed asthma problem-solving skills and strategies along with perceived competence, goal attainment, and comparison to others' skills. The four-item information competence scale assessed parents' understanding of asthma information needs, difficulty in obtaining it, satisfaction with their strategies, and level of control using it. Scales were created as a mean of all items. If more than one item was missing, the scale score was not computed." 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-i? Copy and paste relevant sections from manuscript text Not applicable 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "Tables 4 and 5 present the number of logins, pages viewed, and time spent on the site. Table 4 is based on the total number of potential users (146); Table 5 is based on the number of actual users during each month of access. Figure 5 represents the percentage of potential users that actually used CHESS each month. Figure 5 shows a sharp drop-off from the first to second month and then small declines in most other months. The same can be said for the extent of use. In the last month,usage rates moved up again, possibly because participants knew that the study was coming to an end. This may have led people to employ their last opportunity to use CHESS or it may represent a user wanting to prepare for the exit interview." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 6a-iii? Copy and paste relevant sections from manuscript text "Parents and children returned to the clinic or community center for an exit interview that included taking the same measures used t the intake appointment. Exit interviews were conducted at home for 40 difficult-to-reach MCO 5 parents." "Kathleen K. Shanovich BSN MS, as the lead asthma nurse case manager, supervised the intake and exit interview processes." 6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Our study was powered based on an expected 320 dyads completing the trial; 259 completed the study. We anticipated a dropout rate of 20% but had a rate of 14%."

7b) When applicable, explanation of any interim analyses and stopping guidelines
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Researchers at the University of Wisconsin generated the random allocation sequence. Nurses conducting consent, assent, and pretests were given sequentially numbered envelopes containing the random assignment for each subject. It was not possible to blind participants or outcome assessors. We did blind those doing data analysis."

8b) Type of randomisation; details of any restriction (such as blocking and block size)
Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were equally randomized according to their MCO and then blocked by severity and, after the intake at MCO 5, by Medicaid status.
[41]" 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Nurses conducting consent, assent, and pretests were given sequentially numbered envelopes containing the random assignment for each subject."

10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions
Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Researchers at the University of Wisconsin generated the random allocation sequence. Nurses conducting conset, assent, and pretests were given sequentially numbered envelopes containing the random assignment for each subject."

11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how
NPT: Whether or not administering co-interventions were blinded to group assignment 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

2 3 4 5
subitem not at all important essential Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "It was not possible to blind participants or outcome assessors. We did blind those doing data analysis." 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Potential subjects were informed of . . . . (4) the intervention to be given to the experimental group, (5) the nature and reasons for random assignment, . . . ..."

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Descriptive statistics established baseline characteristics for the CHESS+CM and control groups and for participants with missing data. One-way ANOVA compared differences between the CHESS+CM and control groups and between dropouts and those who completed the study. For missing 3, 6, 9, and 12-month post-test data, a GLM procedure was used to test for equality of mean scores meeting the baseline criteria followed by a one-way ANOVA to determine the P value for the GLM. Scores for outcome variables with no significant mean differences between 3, 6, 9, and 12-months were averaged to create a score for the entire intervention time. [50]" "A multiple regression model, as described by MacKinnon,[51] was used to analyze mediators for outcome variables that showed significant difference between the CHESS+CM and control groups."

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Surveys with missing ACQ® items were not calculated and counted as missing data." "Scales were created as a mean of all items. If more than one item was missing, the scale score was not computed."

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Descriptive statistics established baseline characteristics for the CHESS+CM and control groups and for participants with missing data.
A Bonferroni adjustment for multiple comparisons yielded adjusted P values and confidence limits for mean estimates within each set of comparisons at the four time periods."

X26-i) Comment on ethics committee approval
1 2 3 4 5 subitem not at all important essential

Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "All research materials and procedures were approved by the University of Wisconsin's Health Sciences Review Board, as well as by the ethics and review boards for each of the five managed care organizations." "Recruitment was initiated by a letter from the MCO or WMP to parents of study-eligible patients with an opt-in or an opt-out card regarding a phone call from the study nurse, depending on the organization's IRB policies. [41] Recruiters screened for eligibility, described the study (as a comparison of two approaches to asthma control) and its risks and benefits, and scheduled an intake interview for people who agreed to participate."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Parents were asked to bring the child's medications to the intake interviews. Intakes lasted 45-90 minutes. Potential subjects were informed of (1) the nature and purpose of the study, (2) the financial compensation offered ($35 for completing each of four surveys and providing four spirometry readings), (3) the types of data to be collected from claims records, surveys, and computer-use tracking, (4) the intervention to be given to the experimental group, (5) the nature and reasons for random assignment, (6) the measures used to insure the confidentiality of data collected, (7) the timeline of the study, (8) the duration of the study (12 months, to capture the seasonality of asthma), and (9) the University of Wisconsin--Madison being the research organization for the project. Consent was documented by obtaining signed, IRB-approved consent forms containing all of the above information. The consent forms were kept in a locked file at CHESS. Intake appointments assessed parental ability to read at a sixth-grade level by asking parents to read aloud the consent letter. The appointments also included recording medications and doses, a spirometry test, and the child's asthma history. A researcher administered a pre-test survey with training on completing the asthma diary and provided individualized asthma education as needed. Regardless of study arm, CMs notified MCO staff about children with uncontrolled asthma for further evaluation."

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Participants' misinterpreting information in CHESS posed another risk. The information was presented at a sixth-grade reading level and screened by asthma experts to reduce this risk. Disclaimers also cautioned that the computer is not a substitute for seeking medical attention and that comments in the social media may not be factual. (3) To reduce the risk of anonymity being breached, subjects were assigned a blind code number. All data had names removed and code numbers attached. (4) Participants' divulging confidential information was another risk in the study. We frequently warned users about this, and we used digital signatures to warn users if CHESS was altered."

13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome
NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See Figure 3 for the CONSORT diagram.

13b) For each group, losses and exclusions after randomisation, together with reasons
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See CONSORT diagram-- Figure 3.

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement.

2 3 4 5
subitem not at all important essential

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See Figure 5.

14a) Dates defining the periods of recruitment and follow-up
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Data were collected from August 2, 2004 through August 16, 2007."

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "No significant secular events took place during the study period."

14b) Why the trial ended or was stopped (early)
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable.

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See Table 2 15-i) Report demographics associated with digital divide issues In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study See Table 1.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 16-ii? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Main outcomes were an intent-to-treat analysis with a repeated-measures, mixed model to account for the correlation between the five time points within subjects and to analyze the differences between the time points and baseline within and between the control and CHESS+CM groups." 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Symptom-free days as measured from asthma diaries improved significantly for the CHESS+CM group (OR = 1.38; P = .012) and less so for the control (OR = 1.26, P = .29), but there were no significant between-group differences (OR = 1.18, P = 1.00). Asthma control as measured on the ACQ® improved significantly for CHESS+CM (-.42 on a 7-point Likert scale with lower scores indicating better control, P = .001) and not significantly for the control group (-.11, P = .22). The between-group difference (-.31) was significant (P = .014). The composite medication adherence score showed no significant within-group or between-group changes, with a .58% increase (P = .87) for the control group and 2.06% increase (P = .55) for the CHESS+CM group, and a 1.48% between-group difference (P = .76). Both groups reported declining adherence from diaries and had significant improvements in medication refills." Also see Table 3.

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 17a-i? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Tables 4 and 5 present the number of logins, pages viewed, and time spent on the site. Table 4 is based on the total number of potential users (146); Table  5 is based on the number of actual users during each month of access. Figure  5 shows the percentage of potential users that actually used CHESS each month. Figure 5 shows a sharp dropoff from the first to second month and then small declines in most other months. The same can be said for the extent of use. Except that in the last month the usage rates moved up again, possibly because they knew that the study was coming to an end. This may have led people to employ their last opportunity to use CHESS or it may represent a user wanting to prepare for the exit interview."

17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended
Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Not applicable

22) Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group

22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use)
Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Summary of Primary Outcomes We reported on a randomized control trial that integrated an asthma eHealth program called CHESS with case management (CM) from a monthly telephone call from an asthma nurse. The study enrolled 305 parent/child dyads and randomized 301 dyads. Fifty percent of our sample was non-white and lowincome. Despite the digital divide, the intervention showed significant improvement on pediatric asthma control when measured by the ACQ®, but not when measured as symptom-free days from asthma diaries. The intervention did not have a significant effect on adherence to asthma controller medications. Pharmacy refill rates improved for both groups, yet self-reported adherence declined in both groups. Social support mediated CHESS+CM's effect on the ACQ®. Despite positive trends, no significant effects were found for self-efficacy or information competence. Still the study has important implications because of its focus on (1) low-income, high-risk populations (often African American), (2) an integrated system of nurse case management and eHealth, and (3) mediation analysis to identify the mechanisms of the effect of eHealth systems.

Mediational Effects of Social Support versus Information
Of the three mediational analyses, social support was the only factor that significantly mediated the CHESS+CM effect on asthma control. CHESS+CM had a marginally significant impact on information competence (P =.09), but information competence had no impact on asthma control (P = .63). Conversely, CHESS+CM had a non-significant but promising trend (P = .14) toward improving self-efficacy. The trend was strongly associated with improvements in asthma control (P = .01).
These mediational analyses raise an intriguing question about the relative contribution of social support and information in pediatric asthma management and, as a result, the relative effort that should spent in developing in eHealth technologies, at least for asthma. CHESS+CM's modest improvements in information competence but lack of mediational effect for the ACQ® may result from an insensitive measure or inadequate presentation of information about or the nature of asthma care, or may indicate that knowledge may not be as important as motivation. On the other hand, an exploratory study of a web portal for pediatric diabetes patiens and their parents reported that users put great value on obtaining information from the site.
[46] It might be that for this largely low-income and minority sample of parents, communicating specific asthma information by phone and CMail with trusted, caring case managers is a more effective way to encourage asthma management than reading information in the CHESS program. While these results may not hold for other chronic diseases, we encourage future researchers to consider the relative effects of social support and health information and possible ways to deliver health information in a supportive manner. Interventions themselves may benefit from being simplified, leading to a more extensive adoption and use of eHealth systems."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 22-ii? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Conclusion and Implications for Further Research . . . The present study, however, cannot identify whether the relative impact of the CHESS eHealth program or monthly phone conversations with the case manager affected these outcomes. Further analyses are needed to identify the specific effects for the separate components of CHESS and case management for different participant profiles and to provide important clues about how asthma education can be tailored better to meet the complex needs of managing pediatric asthma within the family context.
From an eHealth perspective, more research is needed into the conditions under which it makes sense to invest heavily in various aspects of disease management [59], such as information versus social support. In the present study, the CM provided asthma information in a supportive and encouraging manner during the monthly phone call--perhaps conflating the relative contribution of information and social support in improving asthma control. In sum, continuous condition-specific research and refinement are needed to develop and implement effective eHealth programs."

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study vehicles for change. If we were to do this study over today, several changes would be been made. We would use GPS tracking to identify when the child entered a pre-specified high-risk location, such as a smoker's home. We would install more reminders to both parents and children. Our social media would have included a service in which parents could exchange tips on how best to promote adherence. We would have added a panic button and services to offer help if a child entered an asthma attack. We would have explored the addition of other sensors, such as a peak flow meter attached to the smart phone. In a second study, we would compare CHESS alone versus CHESS+CM versus control."

21) Generalisability (external validity, applicability) of the trial findings
NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 21-i? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "When this study was initiated, smart phones were just becoming powerful vehicles for change. If we were to do this study over today, several changes would be been made. We would use GPS tracking to identify when the child entered a pre-specified high-risk location, such as a smoker's home. We would install more reminders to both parents and children. Our social media would have included a service in which parents could exchange tips on how best to promote adherence. We would have added a panic button and services to offer help if a child entered an asthma attack. We would have explored the addition of other sensors, such as a peak flow meter attached to the smart phone. In a second study, we would compare CHESS alone versus CHESS+CM versus control.
Still the study has important implications because of its focus on (1) lowincome, high-risk populations (often African American), (2) an integrated system of nurse case management and ehealth, and (3) mediation analysis to identify the mechanisms of the effect of ehealth systems."

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In a routine application setting, the case managers would have been employed by the MCO (possibly making our results more optimistic) an the control group would not have received the extensive attention provided in this study (possibly making our results more conservative)."

23) Registration number and name of trial registry
Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

24) Where the full trial protocol can be accessed, if available
Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The full trial protocol is available at:https://chess.wisc.edu/chess/pdf/protocol/Protocol_Ped_Asthma_FINAL.pdf

25) Sources of funding and other support (such as supply of drugs), role of funders
Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Funding: National Institute for Nursing Research 5R01 NR007889-03

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem X27-i? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The authors have no financial interests in the ehealth system evaluated here, although Gustafson, Wise, and Hawkins were lead members of the development team.

About the CONSORT EHEALTH checklist
As a result of using this checklist, did you make changes in your manuscript? * yes, major changes yes, minor changes no What were the most important changes you made as a result of using this checklist?

Added a use analysis and additional clarifications
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript *

hours
As a result of using this checklist, do you think your manuscript has improved? * yes no Other: Improved somewhat

Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document yes no Other: Depends on what that means.

Any other comments or questions on CONSORT EHEALTH
Please see the paper we wrote on this subject a couple of years ago: Please set up a system to save and return to finish the work.
This was a useful exercise but it took TOO MUCH time.CHESS+CM included a fully automated eHealth component (CHESS) plus monthly nurse case management (CM) via phone. CHESS, based on self-determination theory, contained services designed to improve competence, social support, and intrinsic motivation of parents and children.
This reporting site has a lot of unnecessary duplication and work., For instance the several questions related to randomization. It could have been much easier to complete.

STOP -Save this form as PDF before you click submit
To generate a record that you filled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
When you submit your (revised) paper to JMIR, please upload the PDF as supplementary file.
Don't worry if some text in the textboxes is cut off, as we still have the complete information in our database. Thank you!

Powered by Google Docs
Report Abuse -Terms of Service -Additional Terms