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The prevalence of chronic diseases such as type 2 diabetes and chronic low back pain is rising. Patient empowerment is a key strategy in the management of chronic diseases. Patient empowerment can be fostered by Web-based interactive health communication applications (IHCAs) that combine health information with decision support, social support, and/or behavioral change support. Tailoring the content and tone of IHCAs to the needs of individual patients might improve their effectiveness.
The main objective was to test the effectiveness of a Web-based, tailored, fully automated IHCA for patients with type 2 diabetes or chronic low back pain against a standard website with identical content without tailoring (control condition) on patients’ knowledge and empowerment.
We performed a blinded randomized trial with a parallel design. In the intervention group, the content was delivered in dialogue form, tailored to relevant patient characteristics. In the control group, the sections of the text were presented in a content tree without any tailoring. Participants were recruited online and offline and were blinded to their group assignments. Measurements were taken at baseline (t0), directly after the first visit (t1), and at 3-month follow-up (t2). The primary hypothesis was that the tailored IHCA would have larger effects on knowledge and patient empowerment (primary outcomes) than the control website. The secondary outcomes were decisional conflict and preparation for decision making. All measurements were conducted by online self-report questionnaires. Intention-to-treat (ITT) and available cases (AC) analyses were performed for all outcomes.
A total of 561 users agreed to participate in the study. Of these, 179 (31.9%) had type 2 diabetes and 382 (68.1%) had chronic low back pain. Usage was significantly higher in the tailored system (mean 51.2 minutes) than in the control system (mean 37.6 minutes;
The primary analysis did not support the study hypothesis. However, content tailoring and interactivity may increase knowledge and reduce health-related negative effects in persons who use IHCAs. There were no main effects of the intervention on other dimensions of patient empowerment or decision-related outcomes. This might be due to our tailored IHCA being, at its core, an educational intervention offering health information in a personalized, empathic fashion that merely additionally provides decision support. Tailoring and interactivity may not make a difference with regard to these outcomes.
International Clinical Trials Registry: DRKS00003322; http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00003322 (Archived by WebCite at http://www.webcitation.org/6WPO0lJwE).
Long-term conditions such as type 2 diabetes (T2D) and chronic low back pain (CLBP) are chronic diseases with high and still rising prevalence [
To improve care of long-term conditions, patients, practitioners, scientists, and politicians have called for a greater empowerment of patients in the management of their chronic diseases [
In times of rapidly growing Internet adoption, the Web holds the opportunity to deliver health information [
A specific application of Internet interventions combines health information with at least one other type of support, for example, social support, decision support, or behavior change support: interactive health communication applications (IHCAs). These Internet interventions are expected to improve the knowledge, involvement in decision making, motivation, and self-efficacy of users, resulting in enhanced patient empowerment [
Still, the effectiveness of those online applications is limited by high attrition rates [
Computer tailoring strategies such as the individualization and personalization of information, as well as an interactive presentation, have been found to effectively increase the exposure to [
In this randomized controlled trial, we compared a tailored IHCA presenting information on T2D and CLBP, self-management education, and decision support to a website presenting the same information in a content tree without tailoring. The primary hypothesis was that the tailored and individualized delivery format has a greater effect on knowledge and patient empowerment than the control website. The secondary hypothesis was that users, when facing a health decision, experience less decisional conflict and feel better prepared for the consultation after using the tailored rather than the control website. This paper reports on the trial using the two guidelines that were published in 2011 on designing and reporting Internet intervention research [
We performed a blinded two-armed randomized controlled trial with a parallel design. Measurements were scheduled immediately before the first use of the system (t1), immediately after use (t2), and at 3-months follow-up (t3). Knowledge (primary outcome) and decisional conflict and preparation for decision making (secondary outcomes) were assessed immediately after the first visit. Patient empowerment (primary outcome) was assessed 3 months after the first visit. All measurements were online self-assessment questionnaires. The study design and procedures have been published in two study protocols [
The eligibility criteria were age ≥18 years, access to the Internet, sufficient computer/Internet literacy, and a self-reported diagnosis of T2D or CLBP. CLBP was defined as pain in the lower back almost every day for more than 12 weeks [
In general, based on the Cochrane review by Murray et al [
Recruitment took place using a number of pathways. Two pension funds and six health insurance companies were contacted to request whether they were interested in informing their insurants about the study (eg, via their website, magazine, or newsletter). Three outpatient treatment networks (in which mainly primary care and specialized practices are organized), 15 diabetology practices, 15 practices specialized in CLBP, 87 primary care practices, six rehabilitation centers and hospitals, seven patient associations, and 192 self-help groups were contacted and asked whether they were interested in displaying flyers. Additionally, information on the study and a link to it were disseminated via the mailing list of a population-representative online panel of the University of Münster. Information on the study was also available on the study website. Information and links were placed on the website of the University Medical Centre Hamburg-Eppendorf, as well as on websites that are structurally connected to the work group, one external private diabetes information website, and the website of a doctors’ and therapists’ CLBP network. An article was also published in a regional newspaper (Hamburger Abendblatt).
In this purely Web-based trial without any face-to-face component, every person meeting the eligibility criteria could register for the study on the study website (open survey on a site created exclusively for the study) by providing a unique email address and choosing a password for login. After providing online informed consent and completing the pre-assessment (T2D: eligibility criteria, demographic data, time since diagnosis, treatment; CLBP: eligibility criteria, demographic data, chronic pain grade [
All participants received an email 3 months after their first visit asking them to fill in the online follow-up questionnaire. Participants were reminded by email twice, at 2 weeks and 4 weeks after the first email. Because non-monetary incentives have been shown to reduce attrition in online trials [
Participants were free to use the intervention as often and as long as they wished. Between the post and follow-up assessments, no prompts or reminders were used. No recommendations were provided regarding the duration or frequency of use, but the IHCA was designed to be used in one “go”. Consequently, there were no prompts to use the intervention. No payment was required. Information on the frequency and duration of usage was gathered via server registrations. Usage data, data from the self-assessment questionnaires, and personal data such as name and email address were saved separately. Data were pseudonymized. After data collection, personal data were deleted. If participants withdrew their informed consent to study participation, their data were immediately erased. All data will be erased 5 years after the end of the study.
The study was approved by the Hamburg Medical Chamber ethics committee.
The informed consent outlined that participants would be randomly assigned in consecutive order (50:50) to one of two presentation formats holding the same content. The random allocation (simple randomization) of the participants was automatically performed by the software program, which also provided the website and triggered automatic emails to participants. This centralized, software-driven, computerized, simple randomization procedure to the intervention or control group assured the concealment of allocation, so that randomization could not be subverted by the team of researchers. The two formats were not further elucidated, so participants did not know whether they were in the intervention or control group.
The tailored IHCA is designed as a stand-alone intervention that complements usual care. The T2D content of both the tailored IHCA and the control website covered basic information on diabetes (pathophysiology, epidemiology, subtypes, symptoms) and its sequelae (neuropathy, nephropathy, retinopathy, heart and vessel problems, sexual dysfunction, and depression), information on health behavior and lifestyle changes, and treatment options (see
Overview over the IHCA contents.
Type 2 diabetes | Chronic low back pain |
1. Introduction: What is this website? | 1. Introduction: What is this website? |
1.1. Where does the information on this site come from? | 1.1. Where does the information on this site come from? |
2. Basics | 2. CLBP Basics |
2.1. Different diabetes types | 2.1. Physiological basics: back, spine, and intervertebral discs |
2.2. How do I know I have type 2 diabetes? | 2.2. What exactly is pain? |
2.3. What causes type 2 diabetes? | 2.3. What is the difference between acute and chronic pain? |
2.4. How many people live with type 2 diabetes? | 2.4. Why does the pain stay when the physical injury heals? |
2.5. How is type 2 diabetes diagnosed? | 2.5. How many people live with CLBP? |
2.6. Diabetes ABCs | 2.6. Managing CLBP in everyday life |
2.7. Blood sugar control | 3. How is CLBP diagnosed? |
3. How is type 2 diabetes treated? | 3.1. How much diagnostics makes sense and at which point? |
3.1. What are the goals of diabetes treatment? | 3.2. Diagnostic options |
3.2. What can you do to treat your diabetes? | 4. How is CLBP treated? |
3.3. When should you consider taking pills? | 4.1. How much treatment makes sense and at which point? |
3.4. Insulin treatment | 4.2. What is the natural, untreated course of CLBP? |
3.5. Summary and overview of the treatment options | 5. Are there accompanying conditions or sequelae of CLBP? |
4. Acute complications and sequelae | 6. Treatment options |
4.1. Which acute complications can occur? | 6.1. How do I recognize good treatment? |
4.2. Which sequelae can occur? | 7. Summary |
5. Additional information and literature | 8. Additional information and literature |
5.1. Associations and self-help | 8.1. Associations and self-help |
5.2. Websites | 8.2. Websites |
5.3. Journals | 8.3. Journals |
5.4. Books | 8.4. Books |
6. Glossary | 9. Glossary |
7. Legal notice | 10. Legal notice |
8. References | 11. References |
In the tailored condition, the delivery format was a dialogue-based, tunneled design tailoring the content and tone of the dialogue to relevant patient characteristics. It was developed based on two preliminary studies exploring the quality of existing websites [
Tailoring was performed using the following characteristics for diabetes patients: current T2D knowledge and preferred level of detail, attitudes toward self-care, and, if insulin treatment was a relevant topic, psychological barriers to it. The questionnaires that assessed patient characteristics were presented during the dialogue. At the beginning of the respective section (eg, diabetic foot), the participant was asked about their knowledge or attitude toward the topic, and the following section was then modified according to their answer.
Dialogue window.
Users’ attitudes toward self-care were assessed with items that we adapted from the Summary of Diabetes Self-care Activities Measure (SDSCA) [
For example, if a user attached great importance to the self-care behavior in question, this behavior was reinforced, positive consequences of the self-care behavior were stressed, and/or ideas were provided on how to keep up motivation. If a user found the self-care behavior in question “a little important”, an understanding of the users’ ambivalence was expressed, and the importance the user attached to the self-care behavior (little as it might be) was stressed and reinforced. Finally, if a user rated the self-care behavior as not important, the autonomy expressed in this answer was respected in order not to elicit resistance.
Example of self-care tailoring: Response to “If you feel thirsty and urinate frequently, it usually means your blood sugar is…”.
Response options | Reply |
High (correct answer) | That’s correct! If you want to learn more about what happens in the body and how you know that you have type 2 diabetes, you can go into more detail. Otherwise you can proceed to the next question. I’d like to learn more about that topic. I’d like to proceed to the next question. |
Low (wrong answer) | No, that’s not correct. Actually, it’s the other way around: When you have type 2 diabetes, there is too much sugar in your blood. Unfortunately, you don’t realize it in the beginning. However, there are warning signs. The most important signs are […] |
I don’t know | That’s ok, [name], that’s what we are here for: to learn, for example, what high blood sugar does to your body. |
Psychological barriers to insulin treatment were assessed using the Barriers to Insulin Treatment (BIT) questionnaire [
For CLBP, the concepts of coping style according to the avoidance endurance model (AEM) [
Example of tailoring to coping style (CLBP).
Coping type | Adaptive coper | Happy endurer | Depressed endurer | Depressed avoider |
Description of coping style | You go about your pain in a matter-of-fact manner. You know that on one hand, there is no serious disease behind it but that on the other hand, it can signal to you physical strain. You are good at taking short breaks at the right time to keep up your daily routine – maybe temporarily a little slower than usual. | You tend to keep going in your daily routine even if the pain is strong. This is, on one hand, a personal strength. However, at the same time, you run the risk of actually straining your muscles, ligaments, joints, and intervertebral discs. | You are a multi-tasker. Saying “No” to someone or not getting things done is hard on you. To meet requirements and get things done, you push yourself to your limits and beyond. Often, you don’t listen to your body before it is overstrained. | You are unsettled by your pain. You are worried that there might be a serious disease behind it, and / or you avoid activities that might increase the pain. |
Take home message | Keep on like that! Make exercise part of your routine if you haven´t yet. Choose something fun and back-friendly. If you strengthen your muscles and stick to your relaxing breaks, the pain should soon vanish. | Even if it’s hard, try to pay more attention to your pain and take breaks early enough. Keep working, do things that are pleasant and fun, and keep moving – but remember to pause when you might need to! | Reconsider what you are asking from yourself: do you really have to demand so much? Maybe there are times when it is possible to leave something undone, to do it o.k. instead of perfectly, or to ask for assistance. These things are closely related to your pain. | Pain is unpleasant but not dangerous. Don’t let it suffocate you. Expand your limits step by step, and make pleasant activities a part of your everyday life. |
On the control website, the content was not tailored and was not presented in a dialogue format. In contrast to the tailored, interactive version, the control website was not tunneled, and there was no guidance through the content. On the right side of each page, a content tree displayed a menu of all content sections that the participant could click on to get to the content of interest (see
Control window.
Research focusing on the negative effects of Internet interventions is scarce. One recent study on the side effects of Internet interventions for social anxiety disorder found that 14% of participants experienced negative effects, of which the most frequent was the emergence of new symptoms [
The development process was user-oriented, evidence-based, and peer-reviewed. Two preliminary studies were conducted informing intervention development. To find out which topics are relevant to patients with T2D or CLBP, we performed a needs assessment with two steps. First, we conducted semistructured interviews with 12 physicians (T2D: 7 internists, 2 of whom were specialized in diabetology; CLBP: 5 physicians specialized in orthopedics) and 19 patients (10 with T2D, 9 with CLBP). In the second step, a self-assessment questionnaire was developed based on the main results of the interviews, and it was administered to a new and larger patient sample (T2D: N=178, CLBP: N=117). The needs assessment for T2D is described in more detail elsewhere [
The primary outcomes were knowledge (assessed immediately after the first visit) and patient empowerment (assessed at 3-months follow-up).
T2D knowledge was assessed immediately after the first visit with 16 items, and CLBP knowledge was assessed with 29 items. The items were developed to map the content covered in the sections of the tailored IHCA and could be answered with true/false/I don’t know.
For the context of long-term conditions, patient empowerment was defined as a feeling of confidence and the ability to manage the challenges resulting from the chronic disease [
The secondary outcomes were decisional conflict and preparation for decision making, assessed immediately after the first visit. Decisional conflict was assessed with the Decisional Conflict Scale (DCS) by O’Connor [
Preparation for decision making was measured with the Preparation for Decision Making Scale (PDMS) [
To avoid missing data, all questionnaires included validation checks that alerted participants when their answers were implausible or when items were skipped. Usage data were assessed via log files. Before going online, the usability and technical functionality of the electronic questionnaire was tested by members of the research team. All outcomes were self-assessed through online questionnaires. The questionnaires were not validated for online use.
Data on sample characteristics were analyzed using
To evaluate the effectiveness of the tailored IHCA, multiple linear regression analyses were performed using the intervention, the disease, and their interaction term as dummy-coded predictors. Intention-to-treat (ITT) and available cases (AC) analyses were performed for all outcomes. The ITT approach pooled 10 analyses, estimating missing values by a multiple regression approach using all outcomes, demographic data, and diseases but not intervention information for multiple data imputation (MI). In the primary ITT analysis, a corrected level of significance was used for testing the eight primary outcomes (Bonferroni adjustment); thus, the results with a type I error rate of
The AC analysis included all of the available participants providing valid data on t1 and/or t2. In both analyses, estimated marginal means with standard errors for both the tailored and control conditions were calculated with analysis of variance (ANOVA). Additionally, these parameters were also retained for subgroups stratified by condition. In all AC analyses, results with a type I error rate of
A total of 561 users agreed to participate in the study. Of these, 179 (31.9%) had T2D, and 382 (68.1%) had CLBP. Analyzable data (availability of at least basic demographic information such as age and gender) at t0 were available from 551 users. For data analysis at t1, data for 360 participants was available (availability of data for at least one of the outcomes of t1). Three months after system use, the questionnaires of 295 participants contained data on at least one of the three outcomes at t2 and could thus be used for analyses (
There was also selective dropout between t0 and t1among participants with CLBP. At t1, participants with CLBP were significantly (
Flow of participants after randomization (ITT=intention-to-treat, AC=available cases).
The mean age was 52.2 years (SD 13.1) in the tailored condition and 52.7 years (SD 13.0) in the control condition. Of the participants using the IHCA, 58.5% (162/277) were female (control condition: 59.1%, 162/274). There were no statistically significant differences in further demographic variables such as marital status, educational level, and working status. Sample characteristics are shown in
Sample characteristicsa.
|
Tailored condition t0
|
Control condition t0
|
Baseline differences (tailored vs control condition), |
Total t1
|
Dropout analysis (t1available vs t1not available), |
|
Female, n (%) | 162 (58.5) | 162 (59.1) | .474 | 216 (60.0) | .467 | |
Age in years, mean (SD) | 52.2 (13.1) | 52.7 (13.0) | .668 | 51.8 (13.1) | .116 | |
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Single | 67 (24.2) | 77 (28.1) | .742 | 100 (27.8) | .341 |
|
Married | 162 (58.5) | 150 (54.7) |
|
194 (53.9) |
|
|
Divorced | 39 (14.1) | 37 (13.5) |
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52 (14.4) |
|
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Widowed | 9 (3.2) | 10 (3.6) |
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14 (3.9) |
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Educational level, highb, n (%) | 148 (53.4) | 140 (51.1) | .322 | 198 (55.0) | .089 | |
Working status, employed, n (%) | 145 (55.6) | 160 (58.4) | .282 | 207 (57.5) | .786 | |
Years since diagnosisc, mean (SD) | 11.1 (7.6) | 10.5 (8.0) | .649 | 10.7 (8.2) | .858 | |
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Dietary change | 40 (44.4) | 46 (51.7) | .371 | 57 (50.0) | .535 |
|
Insulin | 35 (38.9) | 25 (28.1) | .154 | 43 (37.7) | .139 |
|
Oral anti-diabetics | 59 (65.6) | 55 (61.8) | .643 | 80 (70.2) | .023 |
Disability scored, mean (SD) | 41.4 (22.5) | 42.7 (22.8) | .573 | 42.2 (20.9) | .855 | |
System usage in minutes, mean (SD) | 51.16 (39.7) | 37.6 (35.0) | <.001 | 49.7 (35.1) | <.001 |
at0 = demographic data available (ITT population); t1= at least one outcome after intervention reported.
bmore than 10 years of education.
cfor patients with diabetes.
dfor patients with back pain.
The following results were obtained using the ITT approach including all randomized participants. The results of the sensitivity analysis using the available cases approach are reported in a separate section.
With regard to knowledge of T2D or CLBP users in the tailored condition had a mean score of 77.9 (SE 1.2) compared with 76.3 (SE 1.3) in the control condition. There were no significant differences between groups (
The heiQ does not provide a total score for patient empowerment.
There was a highly significant disease main effect. After the first use of the system, decisional conflict was lower in the CLBP group than in the T2D group (
There was no significant main effect or interaction.
Results of ITT and AC analyses.
|
N | Tailored condition | Control condition | Intervention main effect |
Disease main effect |
Intervention x disease |
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T2D,M (SE) | CLBP,M (SE) | Total, M (SE) | T2D, M (SE) | CLBP, M (SE) | Total, M (SE) | |||||||
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Knowledge | 551 | 81.3 (1.9) | 74.4 (1.2) | 77.9 (1.2) | 82.9 (2.3) | 69.8 (1.4) | 76.3 (1.3) | .53 | <.001 | .04 |
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|
Positive and active engagement in life | 551 | 71.9 (2.5) | 69.7 (1.8) | 70.8 (1.4) | 71.4 (2.3) | 70.9 (1.8) | 71.2 (1.4) | .88 | .86 | .43 |
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Health directed behavior | 551 | 63.5 (3.9) | 68.7 (2.4) | 66.1 (2.4) | 63.7 (3.3) | 68.3 (2.4) | 66.0 (2.0) | .97 | .28 | .92 |
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|
Emotional well-being | 551 | 68.8 (3.9) | 63.2 (2.8) | 66.0 (2.6 ) | 62.6 (3.7) | 60.2 (2.8) | 61.4 (2.3) | .28 | .60 | .66 |
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Constructive attitudes and approaches | 551 | 78.3 (2.9) | 75.4 (2.1) | 76.8 (1.9) | 75.8 (2.5) | 75.6 (1.9) | 75.7 (1.6) | .498 | .95 | .59 |
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Skill and technique acquisition | 551 | 77.6 (2.6) | 65.1 (1.7) | 71. 4 (1.5) | 75.8 (2.9) | 67.6 (1.7) | 71.7 (1.8) | .62 | .01 | .36 |
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Self-monitoring and insight | 551 | 80.1 (2.1) | 70.8 (1.4) | 75.4 (1.4) | 79.5 (2.2) | 73.4 (1.3) | 76.5 (1.2) | .85 | .04 | .52 |
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Health service navigation | 551 | 77.9 (3.1) | 70.0 (2.1) | 73.9 (2.0) | 74.0 (2.9) | 69.7 (1.8) | 71.8 (1.6) | .32 | .24 | .44 |
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Decisional conflict | 551 | 79.7 (2.3) | 61.3 (1.6) | 70.5 (1.5) | 75.5 (2.3) | 60.3 (1.7) | 67.9 (1.4) | .15 | <.001 | .33 |
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Preparation for decision making | 551 | 60.5 (3.4) | 53.8 (2.5) | 56.7 (2.1) | 57.6 (3.7) | 51.2 (2.3) | 54.4 (2.2) | .57 | .14 | .85 |
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Primary outcome | |||||||||||
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Knowledge | 330 | 81.1 (1.9) | 77.1 (1.4) | 79.1 (1.2) | 81.8 (2.1) | 68.7 (1.3) | 75.2 (1.2) | .02 | <.001 | .008 |
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Positive and active engagement in life | 295 | 71.8 (2.6) | 69.9 (1.8) | 70.9 (1.6) | 71.3 (2.8) | 71.3 (1.8) | 71.3 (1.6) | .86 | .68 | .68 |
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Health directed behavior | 295 | 63.0 (3.4) | 69.4 (2.5) | 66.2 (2.1) | 64.9 (3.7) | 68.7 (2.4) | 66.8 (2.2) | .84 | .10 | .68 |
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|
Emotional well-being | 295 | 70.8 (3.7) | 66.1 (2.6) | 68.5 (2.3) | 60.7 (3.9) | 59.3 (2.5) | 60.0 (2.3) | .009 | .35 | .60 |
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Constructive attitudes and approaches | 295 | 78.8 (2.8) | 76.1 (2.0) | 77.5 (1.7) | 3.2 (0.09) | 74.5 (3.0) | 75.2 (1.9) | .30 | .68 | .51 |
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Skill and technique acquisition | 295 | 78.3 (2.4) | 64.3 (1.7) | 71.3 (1.5) | 75.0 (2.6) | 68.8 (1.6) | 71.9 (1.5) | .78 | <.001 | .06 |
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Self-monitoring and insight | 295 | 80.3 (1.9) | 70.0 (1.3) | 75.2 (1.2) | 79.3 (2.0) | 74.7 (1.3) | 77.0 (1.2) | .27 | <.001 | .09 |
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Health service navigation | 295 | 79.1 (2.7) | 71.2 (1.9) | 75.2 (1.6) | 73.4 (2.9) | 69.8 (1.8) | 71.6 (1.7) | .13 | .02 | .37 |
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Decisional conflict | 324 | 79.9 (2.4) | 61.9 (1.8) | 70.9 (1.5) | 74.8 (2.7) | 60.4 (1.7) | 67.6 (1.6) | .13 | <.001 | .47 |
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Preparation for decision making | 324 | 61.0 (3.3) | 52.1 (2.4) | 56.4 (2.0) | 55.7 (3.6) | 51.2 (2.2) | 53.5 (2.1) | .29 | .02 | .47 |
In addition to the ITT approach, we performed all calculations following the AC approach, including only participants who filled in all of the questionnaires. The aim of this procedure was to determine the extent to which missing data impacted the results reported above (sensitivity analysis).
The AC analysis showed a significant intervention main effect for knowledge (
We found a significant intervention main effect for Emotional Well-being (meaning less health-related negative effects such as anxiety, anger, and depression [
We found a significant disease main effect (
There was a significant disease main effect (
In a randomized controlled trial, we compared a Web-based, tailored, dialogue-based information system containing information on T2D or CLBP (tailored condition) with a website providing identical information without dialogue structure, tailoring, or interactive elements (control condition). The primary outcomes of the trial were knowledge and patient empowerment. Secondary outcomes were decisional conflict and preparation for decision making.
We expected that the tailored IHCA would be more attractive than the control website, be used more, and would thus lead to more knowledge and more empowerment. Indeed, participants spent significantly more time with the tailored website than the control website. Still, this did not lead to more knowledge or empowerment in the primary ITT analysis. In the AC analysis, the participants in the tailored condition displayed more knowledge at t1 and more Emotional Well-being at t2. This indicates that the tailored IHCA was more effective on these two dimensions than the control website. This was not the case for all users included; this was only the case for those who remained in the study and thus spent more time using the system. Contrary to the hypothesis, the tailored IHCA did not result in higher scores on the other six heiQ scales. It is possible that the effect was limited to the emotional level and could not be transferred to the cognitive or behavior level. This is in line with the results of Pal et al, who found that positive effects on cognitive outcomes could not be converted into behavioral changes [
Other recent studies aimed directly at behavioral changes found effects on behavioral outcomes [
There were no significant effects regarding decisional conflict or preparation for decision making. A recent Cochrane review found that decision aids have, among other outcomes, an impact on knowledge and decisional conflict [
Users with T2D yielded significantly better results regarding knowledge, preparation for decision making (only AC), and three (ITT: two) dimensions of the heiQ than participants with CLBP. One possible explanation might be that education and empowerment are traditionally cornerstones of diabetes management [
The work presented is the first trial on a German language IHCA on T2D or CLBP. The intervention was designed carefully based on two preliminary studies. There are some limitations to the work. One limitation concerns the representativeness of the sample. Only people with Internet access could be included in the study. Of the German general population, 73% are online [
We did not include quantitative or qualitative feedback on user acceptance. We also did not assess potential confounders (eg, which other interventions the participants used while enrolled in the study). These variables might have added to our understanding of the IHCA effects. Going beyond the scope of our study, investigating the effectiveness of the tested intervention, further research should focus on the mechanisms of change and the role of context variables through analyzing potential mediators and moderators [
Another limitation arises from the measures used. First, there are concerns regarding data quality and response rates in online questionnaires [
Finally, the intervention had multiple components. We cannot know which component resulted in which effect. Future research should determine which components are effective and which are not.
The tailored IHCA enhanced knowledge and empowerment in persons who actually used it but failed to have effects in the total study population and on more distal outcomes. It might be concluded that tailoring and interactivity do not have effects with regard to these outcomes. Intervention components more specifically targeting cognitive and behavioral outcomes might enhance the effects. Pathways of change connecting intervention components and effects should be explored.
With regard to implementation, the IHCA could function outside of the study without major changes. Still, it would require some resources for updates and maintenance. Involving sponsors from the beginning might facilitate implementation. If our IHCA had made it to this stage, there would have been steps taken to extend its reach and effectiveness. In addition to being more specific, adaptability to tablets and mobile phones might have been an asset [
American Diabetes Association
avoidance endurance model
analysis of covariance
Decisional Conflict Scale
Health Education Impact Questionnaire
Interactive Health Communication Application
Preparation for Decision Making Scale
This study was funded by the German Federal Ministry of Education and Research (grant number: 01GX0710).
NW participated in the conception and design of the study, interpreted the findings, and drafted the manuscript. JD participated in the conception and design of the study, interpreted the findings, and revised the manuscript. AW analyzed the data, interpreted the findings, and participated in drafting and revising the manuscript. LK participated in the conception and design of the study, analyzed the data, interpreted the findings, and participated in revising the manuscript. MH was awarded the grant, participated in the conception and design of the study and the interpretation of the findings, and revised the manuscript.
All authors read and approved the final manuscript.
NW, JD, and MH were among the developers of the intervention.
CONSORT-EHEALTH checklist V1.6.2 [