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. Data were collected from October 2018 to January 2021. We collected the data at 4 time points: baseline (prior to randomization, T0), 1 month after beginning the intervention (T1), after completing 3 months of the intervention (T2), and after completing 6 months of the intervention (T3).

Participants were recruited from the cardiovascular outpatient department at a medical center in northern Taiwan through convenience sampling. 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.

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 [26]. Finally, 116 participants were assigned into the intervention group and 116 participants were assigned into the control group. The patients in the intervention group received the web-based integrated management program, whereas those in the control group received consultations and were coached thrice by a research nurse over telephone.

This study was approved by the Institutional Review Board of the participating hospital (IRB: 2-107-05-081; ClinicalTrials.gov NCT04813094) and conducted in accordance with the principles of the Declaration of Helsinki revised in 2000. A research nurse explained the research process to each participant and obtained informed consent from them. We ensured that the participants were kept anonymous. In addition, participants were informed that they had the right to withdraw from the study at any time for any reason.

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 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, including age, gender, years of education, type of AF, modified European Heart Rhythm Association (mEHRA) classification, comorbidities, and use of anticoagulation medication. In the instructions on AF knowledge domain, participants were able to receive information about AF through texts and videos, including an introduction to AF, the risk factors and symptoms of AF, how to prevent stroke in patients with AF, and how to manage a healthy lifestyle. The videos were also available in Taiwanese and Mandarin. In the instructions on anticoagulation medicine domain, the participants were able to obtain descriptions about a variety of anticoagulant medicines. There was textual information about anticoagulant medicines, such as the effectiveness and adverse effects of these medicines, and precautions to be taken, as well as pictures of the corresponding medicines to serve as references for the participants. In the self-monitoring of symptoms domain, participants could provide record their symptoms every day, which could assist them in monitoring their disease progress and provide cardiologists with references to regulate their treatment. 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. 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).

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.

Patients in the control group received standard instructions. The AF management manual was provided to them with explanations. In addition, we provided telephonic coaching thrice, which taught participants how to manage their disease at 1 month, 3 months, and 6 months after random assignment.

A total of 258 patients were recruited from the outpatient department of the study hospital according to the inclusion criteria. Of these patients, 26 refused to participate. At the end of the study, the complete data of 115 participants in the intervention group and 116 participants in the control group were included for the statistical analysis. One participant in the intervention group was lost to follow-up owing to emigration (Figure 3). The mean age of the participants was 73.08 (SD 11.71) years. Half of the participants were male (116/231, 50.2%), and over half of the participants were married (155/231, 67.1%). Most participants were diagnosed with paroxysmal AF (171/231, 74%), and the most frequent comorbidity was hypertension (162/231, 70.1%). Assessing the classification of AF symptoms through mEHRA indicated that 44.6% (103/231) of the participants were class I, 22.9% (53/231) were class IIa, 14.7% (34/231) were class IIb, and 17.7% (41/231) were class III. Approximately 36.4% (84/231) of the participants received rivaroxaban, and 27.3% (63/231) received apixaban. There were no significant differences in the demographic and clinical characteristics, and the baseline scores of each scale between the two groups (Table 1).

The GEE model analysis showed a significant difference in the scores of the approach coping subscale between the intervention and control groups at 1 month (β=.792; 95% CI 0.143-1.172; P<.001), 3-months (β=1.297; 95% CI 0.441-2.153; P=.003), and 6 months (β=1.902; 95% CI 0.882-2.922; P<.001) (Table 2 and Figure 4).

In addition, the intervention group showed a significantly higher decrease in the scores of the avoidance coping subscale at 1 month (β=–2.284; 95% CI –2.885 to –1.683; P<.001), 3 months (β=–2.602; 95% CI –3.511 to –1.694; P<.001), and 6 months (β=–2.982; 95% CI –4.096 to –1.869; P<.001) compared with the control group (Table 2 and Figure 4). These findings indicated that the web-based integrated management program helped participants to use more approach coping strategies and less avoidance coping strategies in managing their AF-related issues.

The GEE model analysis showed significant differences in the scores of the MARS between the intervention and control groups at 1 month (β=.326; 95% CI 0.034-0.618; P=.03), 3 months (β=.595; 95% CI 0.24-0.95; P=.001), and 6 months (β=.606; 95% CI 0.253-0.96; P=.001) (Table 3 and Figure 5). These results indicated that after receiving the web-based integrated management program, the AF patients showed significantly better medication adherence than that shown by the patients in the control group.

The GEE model analysis showed no significant difference in the EQ-5D scores between the 2 groups at 1 month (β=.042; 95% CI –0.014 to 0.980; P=.14). However, the patients in the intervention group showed significantly higher EQ-5D scores at 3 months (β=.082; 95% CI 0.028-0.137; P=.003) and 6 months (β=.19; 95% CI 0.13-0.25; P<.001) than the patients in the control group (Table 4 and Figure 6).

In addition, the GEE model analysis revealed significant differences between the 2 groups in the EQ-VAS scores at 1 month (β=2.071; 95% CI 0.551-3.592; P=.008), 3 months (β=3.838; 95% CI 2.169-5.506; P<.001), and 6 months (β=5.782; 95% CI 3.837-7.727; P<.001) (Table 4 and Figure 6). These results indicated that the AF patients receiving the web-based integrated management program showed a significantly higher HRQoL improvement than that shown by the patients in the control group.

During the study, we followed the readmission events within 2 years after intervention. A total of 34 readmission events occurred. There were 11 readmission events in the intervention group and 23 in the control group. The predictor variables with P<.20 were based on univariate logistic regression. The predictor variables meeting the criteria were patients aged over 65 years, the mEHRA IIa class, comorbidities such as valvular heart disease and heart failure, receiving clopidogrel, and group assignment (Table 5). According to the multivariate logistic regression model, the intervention group showed significantly fewer readmission events within 2 years (OR 0.406; 95% CI 0.178-0.926; P=.03) compared with the control group (Table 5). These results indicated that the patients with AF receiving the web-based integrated management program had a lower probability of readmission within 2 years, compared with the control group.

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.

The findings of this study identified that the AF patients receiving this program increased the usage of approach coping strategies and decreased the usage of avoidance coping strategies, as opposed to the patients in the control group. Individuals who used approach coping strategies were able to actively solve problems and conduct positive reappraisals [34]. As the patients were able to receive information immediately and appropriately through this web-based program, they became more confident in solving their problems. On the other hand, the patients in the control group received the manual for AF management to address their problems. They always complained that they did not have sufficient disease information and immediate discussions with clinical professionals when they faced problems. They resorted to using more avoidance coping strategies. Although avoidance coping strategies may be useful in temporarily reducing stress, they increase suffering and mortality, and decrease medication adherence and quality of life [35-37].

Furthermore, in our study, patients receiving the web-based program showed significant improvements in medication adherence and HRQoL, which resulted from the improved disease knowledge and empowerment to solve their problems. Wang et al pointed out three reasons why knowledge may improve medication adherence in patients with AF; first, they become more knowledgeable about the importance of anticoagulant treatment; second, they develop the ability to detect the adverse effects of anticoagulant medicines; third, they received more self-care information about managing the symptoms of AF and adverse effects of the medicines [38]. In addition, Ammenwerth et al suggested that integrated management with eHealth schemes can increase motivated lifestyles and adherence to medical recommendations, thereby improving the health status and HRQoL [39]. Our findings were consistent with those of previous studies [40,41]. All the findings proved that patients were able to manage their treatment and lifestyle by themselves through a web-based program providing positive coping strategies and sufficient disease knowledge and could therefore improve their medication adherence and HRQoL.

To test the second hypothesis that the patients in the intervention group would experience fewer 2-year readmission events than those in the control group, we followed the readmission status of AF patients for 2 years. Our findings showed significantly fewer readmission events within 2 years in patients who received the web-based integrated management program compared to those in the control group. Marcolino et al proposed that implementing web-based intervention programs can improve communication between patients and medical providers and provide assistance in disease management to promote health recovery of patients [42]. In our study, through the web-based integrated management program, direct communication between the patients/their families and health professionals was possible when the patients went back home. A randomized control trial involving patients with heart failure showed that using a remote medication monitoring system can greatly improve patients’ medication adherence and reduce all-cause readmission events. It reduced the risk of readmission by 80% [43]. Our findings were consistent with these previous ones [44,45]. Because of the web-based integrated management program, we empowered patients to change their coping strategies and increase their compliance to medical treatment. Ultimately, it improved the HRQoL and long-term beneficial clinical effects in patients with AF in terms of reducing 2-year readmission events.

The study provides useful information for health care professionals regarding web-based integrated management programs for optimizing AF management. The most important findings of the study are summarized as follows: The web-based integrated management program can significantly improve patients' coping strategies and medication adherence, and help patients maintain disease stability, which has a major influence on improving the HRQoL and reducing adverse clinical events and readmission episodes. Overall, the program may improve the quality of patient care while reducing medical costs.

Some limitations of this study should be considered. First, the sample may not reflect the entire AF population owing to the disease severity of most patients being mild or moderate. If AF patients had severe symptoms, they were hospitalized to receive medical interventions. Therefore, most of the AF patients in the community only had mild or moderate symptoms. However, they still had very limited knowledge on self-managing their symptoms. After receiving this program, they were able to take care of themselves, leading to decreased readmission events. Second, the single-center design limited the generalization of the findings. Third, factors that affect medication adherence and readmission, such as social support and economic status, were not included in the present study. As there were no differences in the educational levels and marital statuses of the patients in the intervention and control groups, we assumed that both groups of patients had similar social support levels and economic statuses. Nevertheless, future studies should examine these two factors and control their influence.