Effects on Adherence to a Mobile App–Based Self-management Digital Therapeutics Among Patients With Coronary Heart Disease: Pilot Randomized Controlled Trial

Abstract

Background The adherence to secondary prevention treatment in patients with coronary heart disease (CHD) is low. Digital therapeutics (DTx) refers to an emerging branch of medicine that delivers medical interventions directly to patients using evidence-based, clinically evaluated, technology-based software algorithms or apps to facilitate disease management, which may be an efficient tool to optimize adherence. Objective This paper aims to investigate the effect of mobile app–based self-management DTx on long-term use of secondary prevention medications in patients with CHD in China. Methods This pilot study was a parallel-designed, open-labeled, single-center, randomized controlled trial. Hospitalized patients with CHD admitted to Peking University First Hospital between April 2016 and June 2017 were randomized before discharge on a 1:1 ratio. The intervention group received regular follow-up combined with DTx, which is a self-management mobile app already installed on an Android 5 (Mi Pad 1, Xiaomi Corporation) tablet. Structured data from the hospital informatics system were integrated automatically, and medication, lifestyle intervention plan, follow-up protocol, and patient education materials were also provided according to the diagnosis. Participants could use DTx for self-management at home. The control group was under conventional hospital–based follow-up care. Patients were followed up for 1 year, and the primary end point was the percentage of all guideline-recommended medications at 12 months. The secondary end points included the percentage adhered to standard secondary prevention medications at 6 months, the control rate of lipid profile, and blood pressure at 6 months and 1 year. Results Among 300 randomized patients with CHD, 290 (96.7%) were included in the final analysis, including 49.3% (143/290) and 50.7% (147/290) of patients from the intervention and control groups, respectively. Baseline characteristics were similar between the 2 groups. There was a statistically significant improvement in the percentage of all guideline-recommended medications at 12 months in the intervention group compared with the control group (relative risk [RR] 1.34, 95% CI 1.12-1.61; P=.001), and there was no interaction with baseline characteristics. The intervention group had a significantly higher proportion of patients achieving blood pressure under control (systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg) and low-density lipoprotein cholesterol <1.8 mmol/L (RR 1.45, 95% CI 1.22-1.72; P<.001 and RR 1.40, 95% CI 1.11-1.75; P=.004, respectively) at 12 months. Furthermore, on logistic regression, the intervention group had a lower risk of withdrawing from guideline-recommended medications (odds ratio 0.46, 95% CI 0.27-0.78; P=.004). Conclusions Among patients with CHD, using a mobile app–based self-management DTx in addition to traditional care resulted in a significant improvement in guideline-recommended medication adherence at 12 months. The results of the trial will be applicable to primary care centers, especially in rural areas with less medical resources. Trial Registration ClinicalTrials.gov NCT03565978; https://clinicaltrials.gov/ct2/show/NCT03565978

Digital therapeutics in the clinic

“…DTx products are presented as highquality software that are designed to treat, manage, or prevent a medical condition. 27,28 The software can be further divided into subtypes such as mobile applications, 29 web applications, 30,31 virtual reality (VR), 32 AI, 33,34 video games, 35 and approved devices, among others.…”

“…DTx have shown promise in various disease areas including psychiatric, [36][37][38] cardiovascular, 29,39 metabolism, 40 gastrointestinal, 41 neurodevelopmental, 33,42 and neurological diseases, 43,44 among others. With such a broad application, DTx hold great potential in translatability and treatment across different disease areas among the general population.…”

Digital health technology in the prevention of heart failure and coronary artery disease

“…Mobile digital technology has also been found to be effective in risk factor management in the secondary prevention of coronary artery disease. A recent single-center RCT published in 2022 24 randomized 290 patients with coronary artery disease to receive conventional care or conventional care and a smartphone app for self-management. Patients were enrolled during admission to a tertiary hospital in China and required a diagnosis of coronary artery disease, as defined by a previous myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, or ≥50% stenosis in at least 1 major epicardial vessel on coronary angiography.…”

“… 27 Future research agendas should consider access and usability of digital health technology for patients; system integration and harmonization for provider workflow; and technology costs and healthcare utilization. 24 The longest minimum follow-up period for the above-mentioned studies in both HF and coronary artery disease study was 12 months. A longer duration of monitoring may have allowed for a difference in readmission rates and mortality to have been identified, particularly for patients with acute coronary syndromes, which may take many years to recur after suboptimal risk factor management.…”

“…Poor patient adherence. Standard care No difference in all-cause mortality or readmission for any cause Koehler, 2018 18 Multicenter RCT, heart failure 1571 patients, 393 days Telemonitoring system, patient education, monthly phone calls Standard care Reduction in days lost to unplanned hospital admission or mortality Chen, 2019 21 Single-center RCT, heart failure 767 patients, 180 days 2 arms; structured telephone support and SMS-based support system Inpatient nurse heart failure education Reduced readmission rates and improved self-care (medication compliance) in SMS group vs control Tekkeşin, 2021 23 Single-center RCT, high-cardiovascular-risk patients 483 patients, 12 months Smartphone app + remote monitoring devices + motivational text messages Standard care Reduction in 10-year cardiovascular risk Li, 2022 24 Single-center, RCT, coronary artery disease 290 patients, 12 months Smartphone self-management app + remote monitoring device Standard care Increase in use of guideline-directed medical therapy, reduction in blood pressure and LDL cholesterol HF = heart failure; RCT = randomized controlled trial. …”