Abstract 189: Why Digital Health Trials Can Fail: Lessons Learned from the SmartGUIDE Randomized Trial of Virtual Cardiac Rehabilitation

Abstract

Background: We performed a trial to evaluate the efficacy of a blended intervention with a custom-designed smartphone app combined with health coaching to improve medication adherence and cardiovascular risk factors. The trial failed to achieve objectives due to a number of factors. Here, we describe findings from a root cause analysis and lessons learned. Methods: SmartGUIDE was an open-label, single center trial of patients with coronary artery disease who were prescribed a statin and/or P 2 Y 12 antagonist that randomized 1:1 to either usual care or the use of a mobile app paired with personal virtual coaching. The primary outcome for medication adherence was the proportion of days covered (PDC). The planned sample size was 132 for 80% power. However, the study was terminated early with only 63 patients randomized and data of 26 patients ultimately available for analysis. We performed a root cause analysis using the 5-Whys technique to evaluate processes from study development to closure. Results: Figure 1 shows an Ishikawa cause-and-effect diagram for root cause analysis of trial failure. Root causes included aspects of intervention design, study design, enrollment, and retention. Many factors were related to the startup partner’s product design, inexperience in health care, and insufficient funding. Conclusion: We identified important and preventable factors leading to failure to achieve the trial objectives. These factors may be common across digital health trials and may explain prior observations that many such trials are never completed. Careful vetting of technology partners and more pragmatic study designs may be important lessons.