Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Jul 19, 2021
Date Accepted: Dec 10, 2021
Date Submitted to PubMed: Dec 15, 2021
The Effects on Adherence of a Mobile Application-based Self-management Digital Therapeutics among Coronary Heart Disease Patients: Pilot Randomized Controlled Trial
ABSTRACT
Background:
The adherence to secondary prevention treatment in coronary heart disease (CHD) patients is low. Digital therapeutics (DTx) may be an efficient tool to optimize the adherence.
Objective:
To investigate the effect of a mobile application-based self-management DTx on long-term use of secondary prevention medications in CHD patients in China.
Methods:
This BAMA pilot study was a parallel-designed, open-labeled, single-center, randomized controlled trial. CHD patients were randomized (1:1) into the intervention group receiving a mobile application-based intervention besides standard care and the control group receiving conventional hospital-based follow-up care. Primary endpoint was the percentage of all guideline-recommended medications at 12 months.
Results:
Among 300 randomized CHD patients, 290 were included in the final analysis, including 143 and 147 patients of the intervention and control groups, respectively. There was a statistically significant improvement in the primary endpoint in the intervention group compared with control (relative risk [RR] 1.34 [95% confidence interval [CI]: 1.12-1.61], P=0.001), and there was no interaction with baseline characteristics. The intervention group had a significantly higher proportion of patients achieving blood pressure under control and low-density lipoprotein cholesterol (LDL-C) <1.8 mmol/L (RR 1.45 [95%CI: 1.22-1.72], P<0.001 and RR 1.40 [95%CI: 1.11-1.75], P=0.004, respectively) at 12 months. On logistic regression, the intervention group had a lower risk of withdrawing guideline-recommended medications (odds ratio [OR] 0.46 [95%CI: 0.27-0.78], P=0.004).
Conclusions:
Among CHD patients, using a mobile application-based self-management DTx in addition to traditional care resulted in a significant improvement in guideline-recommended medication adherence at 12 months. Clinical Trial: Clinical.gov registration: NCT03565978
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.