A Web-Based Integrated Management Program for Improving Medication Adherence and Quality of Life, and Reducing Readmission in Patients With Atrial Fibrillation: Randomized Controlled Trial

Background Atrial fibrillation (AF) is related to a variety of chronic diseases and life-threatening complications. It is estimated that by 2050, there will be 72 million patients with AF in Asia, of which 2.9 million will have AF-associated stroke. AF has become a major issue for health care systems. Objective We aimed to evaluate the effects of a web-based integrated management program on improving coping strategies, medication adherence, and health-related quality of life (HRQoL) in patients with AF, and to detect the effect on decreasing readmission events. Methods The parallel-group, single-blind, prospective randomized controlled trial recruited patients with AF from a medical center in northern Taiwan and divided them randomly into intervention and control groups. Patients in the intervention group received the web-based integrated management program, whereas those in the control group received usual care. The measurement tools included the Brief Coping Orientation to Problems Experienced (COPE) scale, Medication Adherence Rating Scale (MARS), the three-level version of the EuroQoL five-dimension self-report questionnaire (EQ-5D-3L), and readmission events 2 years after initiating the intervention. Data were collected at 4 instances (baseline, 1 month, 3 months, and 6 months after initiating the intervention), and analyzed with generalized estimating equations (GEEs). Results A total of 231 patients were recruited and allocated into an intervention (n=115) or control (n=116) group. The mean age of participants was 73.08 (SD 11.71) years. Most participants were diagnosed with paroxysmal AF (171/231, 74%), and the most frequent comorbidity was hypertension (162/231, 70.1%). Compared with the control group, the intervention group showed significantly greater improvement in approach coping strategies, medication adherence, and HRQoL at 1, 3, and 6 months (all P<.05). In addition, the intervention group showed significantly fewer readmission events within 2 years (OR 0.406, P=.03), compared with the control group. Conclusions The web-based integrated management program can significantly improve patients' coping strategy and medication adherence. Therefore, it can empower patients to maintain disease stability, which is a major factor in improving their HRQoL and reducing readmission events within 2 years. Trial Registration ClinicalTrials.gov NCT04813094; https://clinicaltrials.gov/ct2/show/NCT04813094.


2a-i) Problem and the type of system/solution
"The main findings of this study were that the web-based integrated management program significantly improved coping strategies, medication adherence, and HRQoL in patients with AF after 1, 3, and 6 months of intervention. In addition, the AF patients receiving the web-based integrated management program had a lower probability of readmission within 2 years after intervention compared with the patients not receiving this program".

2a-ii) Scientific background, rationale: What is known about the (type of) system
"Prior studies support the use of eHealth to assist patients in conducting advanced disease management. A few randomized controlled trials had investigated the impact of eHealth on medication adherence in patients with AF for 3 months. Although the use of eHealth management significantly improved medication adherence at 3 months after intervention, the long-term effects on medication adherence remain to be investigated. Again, integrated management aims to improve patients' disease knowledge and empower patients to manage their disease. Integrated management needs the involvement of patients and multidisciplinary AF teams. Multidisciplinary professionals using technological support such as eHeath provide disease information and selfcare skills to AF patient. As a result,advanced and integrated disease management programs are expected to improve medication adherence and disease control in patients with AF". Does your paper address CONSORT subitem 2b?
"In this study, we aimed to evaluate the effects of a web-based integrated management program on improving coping strategies, medication adherence, and health-related quality of life (HRQoL) in patients with AF, and to detect its effect on decreasing readmission events. Therefore, we have two hypotheses. The first hypothesis is that the AF patients receiving the web-based integrated management program in the intervention group would use more approach coping strategies and improve their medication adherence and HRQoL compared with the patients in the control group. The second hypothesis is that the patients in the intervention group would have fewer 2-year readmission events than the patients in the control group". METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio "This study was a prospective, single-blind, randomized controlled trial with repeated measurements to determine the effects of a 6-month web-based integrated management program on improving the coping strategy, medication adherence, and HRQoL, and decreasing 2-year readmission events in patients with AF". "In total, 324 patients were screened in the cardiovascular outpatient department, and 258 patients were eligible to be included. Among the eligible patients, 26 patients refused to participate. The remaining 232 participants were randomly assigned into 2 groups by blocked randomization using a web-based system". 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons There were no important change to the methods after trial commencement. 3b-i) Bug fixes, Downtimes, Content Changes 4a) CONSORT: Eligibility criteria for participants "Patients were included if they met the following criteria: (1) diagnosed with AF by cardiologists, (2) receiving anticoagulant treatment, (3) aged above 20 years, (4) able to speak and read Taiwanese or Mandarin to understand and follow instructions, and (5) able to use a mobile phone or computer correctly. The exclusion criteria included the following: (1) diagnosed with mental disorders or (2) involved in other clinical trials" 4a-i) Computer / Internet literacy 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: "Participants were recruited from the cardiovascular outpatient department at a medical center in northern Taiwan through convenience sampling. ...." "The remaining 232 participants were randomly assigned into 2 groups by blocked randomization using a web-based system. Finally, 116 participants were assigned into the intervention group and 116 participants were assigned into the control group...." "The web-based integrated management program was conducted in the cardiovascular outpatient department. Participants had their own account and password to log in to the web-based program via mobile phones or computers........." "The research nurse also sent messages every day to monitor the participants' condition through the messaging function of this domain. When the participants had an emergency event, they could receive help to manage this situation through textual information or telephonic coaching." "After face-to-face presentations, we ensured that the participants fully understood the instructions for using this web-based program by the return demonstration method. We reviewed their understanding of the program at the next outpatient visit. In addition, we instructed participants on managing AF and anticoagulant treatment through the web-based program and provided the AF management manual to them." 4a-iii) Information giving during recruitment 4b) CONSORT: Settings and locations where the data were collected Participants were recruited from the cardiovascular outpatient department at a medical center in northern Taiwan through convenience sampling.

4b-i) Report if outcomes were (self-)assessed through online questionnaires
The research nurse administered self-complete questionnaires to patients at baseline, 1 month, 3 month, and 6 months. 4b-ii) Report how institutional affiliations are displayed 5) CONSORT: Describe 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 5-ii) Describe the history/development process 5-iii) Revisions and updating 5-iv) Quality assurance methods 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used

5-vii) Access
A secure website was designed to assist patients in performing safe self-management their disease. We assisted participants with free set-up required on their smartphones or tablets. 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework "The program included five domains: patient information collection, instructions on AF knowledge, instructions on anticoagulation medicine, self-monitoring of symptoms, and professional consultation". "In the patient information collection domain, the participants were able to provide and read their information...." "In the instructions on AF knowledge domain, participants were able to receive information about AF through texts and videos..." "In the instructions on anticoagulation medicine domain, the participants were able to obtain descriptions about a variety of anticoagulant medicines...." "In the self-monitoring of symptoms domain, participants could provide record their symptoms every day.." "In the professional consultation domain, participants could receive consultations from multidisciplinary professionals on any issues related to AF at any time..." "All the participants had their own private consultations with clinical professionals." 5-ix) Describe use parameters 5-x) Clarify the level of human involvement 5-xi) Report any prompts/reminders used "The research nurse also sent messages every day to monitor the participants' condition through the messaging function of this domain. When the participants had an emergency event, they could receive help to manage this situation through textual information or telephonic coaching (Figures 1 and  2)."

5-xii) Describe any co-interventions (incl. training/support)
..."a 6-month web-based integrated management program".... "The patients in the intervention group received the web-based integrated management program." 6a) CONSORT: Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed The research nurse administered self-complete questionnaires to patients at baseline, 1 month, 3 month, and 6 months. Primary outcomes: Coping Strategies(Brief Coping Orientation to Problems Experienced scale) Medication Adherence (Medication Adherence Rating Scale) Medication Adherence Rating Scale (three-level version of the EuroQol five-dimension self-report questionnaire (EQ-5D-3L)) Secondary outcomes: Readmission Events Within 2 Years (After recruiting the patients in the study, we followed their readmission events for 2 years. We collected these data through chart reviews of each participant.) 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained 6b) CONSORT: Any changes to trial outcomes after the trial commenced, with reasons Participants were recruited from the cardiovascular outpatient department at a medical center in northern Taiwan through convenience sampling. 7a) CONSORT: How sample size was determined 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size 7b) CONSORT: When applicable, explanation of any interim analyses and stopping guidelines The research nurse administered self-complete questionnaires to patients at baseline, 1 month, 3 month, and 6 months. Primary outcomes: Coping Strategies(Brief Coping Orientation to Problems Experienced scale) Medication Adherence (Medication Adherence Rating Scale) Medication Adherence Rating Scale (three-level version of the EuroQol five-dimension self-report questionnaire (EQ-5D-3L)) Secondary outcomes: Readmission Events Within 2 Years (After recruiting the patients in the study, we followed their readmission events for 2 years. We collected these data through chart reviews of each participant.) 8a) CONSORT: Method used to generate the random allocation sequence " In total, 324 patients were screened in the cardiovascular outpatient department, and 258 patients were eligible to be included. Among the eligible patients, 26 patients refused to participate. The remaining 232 participants were randomly assigned into 2 groups by blocked randomization using a web-based system....." 8b) CONSORT: Type of randomisation; details of any restriction (such as blocking and block size) " In total, 324 patients were screened in the cardiovascular outpatient department, and 258 patients were eligible to be included. Among the eligible patients, 26 patients refused to participate. The remaining 232 participants were randomly assigned into 2 groups by blocked randomization using a web-based system....." 9) CONSORT: 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 " In total, 324 patients were screened in the cardiovascular outpatient department, and 258 patients were eligible to be included. Among the eligible patients, 26 patients refused to participate. The remaining 232 participants were randomly assigned into 2 groups by blocked randomization using a web-based system....." 10) CONSORT: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions The statistician who generated the random allocation sequence by a web-based system. The research nurse who enrolled participants, and assigned participants to intervention based on the allocation sequence. 11a) CONSORT: Blinding -If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11a-i) Specify who was blinded, and who wasn't "A research nurse explained the research process to each participant and obtained informed consent from them." The analysis was conducted by researchers who were unaware of the random allocation. 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" 11b) CONSORT: If relevant, description of the similarity of interventions Not applicable to this trial. 12a) CONSORT: Statistical methods used to compare groups for primary and secondary outcomes "The effects of the web-based integrated management program on the coping strategy, medication adherence, HRQoL, and readmission events were examined using a generalized estimating equation (GEE). The significance level was defined by a two-tailed t test with P<.05." "We used univariate logistic regression to assess the association between patient characteristics, including group assignment, and readmission events within 2 years and identify the predictor variables. ....." 12a-i) Imputation techniques to deal with attrition / missing values Not applicable to this trial. 12b) CONSORT: Methods for additional analyses, such as subgroup analyses and adjusted analyses