Feasibility and Initial Efficacy of Home-Based Cardiac Telerehabilitation— A Pilot Study
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Background: Cardiovascular Disease (CVD) is the top health problem all over the world, including China. Home-based rehabilitation after cardiac surgery has been shown to be beneficial. In our study, a clinical study has been carried out to investigate the feasibility and effectiveness of using emergent mobile and information technology to deliver monitoring and feedback function in Home-Based Cardiac Telerehabilitation program (HBCTR). The main purpose of this study is to assess the feasibility and acceptance of the HBCTR program in low risk patients post Percutaneous Coronary Intervention (PCI). The secondary purpose is to assess the initial efficacy of the HBCTR program. Method: A single-blinded parallel two-arm Randomized Controlled Trial (RCT) has been conducted at the First Affiliated Hospital of Shantou University Medical College, China. A total of 24 post PCI patients were recruited and randomly divided into two equal groups. The control group (Usual Care (UC) program) received paper-based CVD educational booklets and biweekly outpatient review. The experiment group (HBCTR program) carried out outdoor walking/jogging exercise with real time physiological monitoring along with CVD education materials. Feasibility and acceptance of the HBCTR program were evaluated by using an acceptance questionnaire, a satisfaction questionnaire, patients’ adherence evaluation, system abnormalities analysis, and safety evaluation. The effectiveness of this program was measured by using 6 Minutes Walking Test (6MWT), Fagerstrom Test for Nicotine Dependence (FTND), Cardiac Depression Scale (CDS)), and SF-36 Health Survey. Results: A total of 53 respondents completed the HBCTR patient acceptance questionnaire, and 22 participants completed the RCT. One experiment group participant withdrew, and one control group participant lost contact during the RCT. 67.9% of participants deemed the HBCTR program acceptable due to real time exercise monitoring and emergency alert function. Features including real time exercise monitoring and emergency alerts are attributed to the high acceptance of the HBCTR program. The HBCTR program is perceived to allow patients to exercise in a safer and more independent manner compared to the UC method, and 81.8% of participants (n=9) felt satisfied with the HBCTR program. The average adherence rates of HBCTR in terms of exercise trainings, self-reporting, and medication intake are 92.9%, 88.4%, and 90.0% respectively. No serious adverse event was reported in the study; Out of the 184 exercise trainings the HBCTR remote monitoring system had only 7(3.8%) temporary system failures. After the six- week intervention, both groups resulted in statistically significant improvements in SF-36 physical component summary (PCS), SF-36 mental component summary (MCS), 6MWT, FTND, DASI, and CDS. Furthermore, patients in the experimental group had better improvements compared to patients in the control group in PCS scores in SF-36 (HBCTR: Δ12.5±7.8 vs UC: Δ 4.6±5.7), DASI (HBCTR: Δ0.7±0.5 vs UC: Δ 0.3±0.4), and 6 MWT (HBCTR: Δ45.5±17.4 vs UC: Δ27.6±14.7). Conclusion: The proposed HBCTR program is feasible and safe for low-risk post PCI patients. Although improvements were observed in both groups, the physical indicators of PCS and 6MWT of HBCTR patients exceeded those of the UC patients. The patients in the HBCTR program showed high satisfaction and decreased fears in performing rehabilitation exercise “at home” with remote monitoring. With this decreased fears in exercise, the adherence among the HBCTR patients was high which resulted in their benefit physical outcomes. Future study with multiple centers and a large-scale randomized controlled trial can be carried out to further assess the efficiency of the HBCTR program in long term. Cost analysis also can be added into the further study to compare the cost effective between HBCTR and traditional center-based CR.