Effects of a Mobile Health Behavior Change Intervention for Women with Coronary Heart Disease: A Pilot Randomized Controlled trial (Preprint)

BACKGROUND Coronary heart disease afflicts 7 million American women annually and is their leading cause of disability globally. Women are undertreated and underrepresented in research; rectifying sex-specific disparities in coronary heart disease outcomes is a national priority. Effective interventions for improving the cardiovascular health behaviors of women are vital for addressing this gap in care. OBJECTIVE In this pilot randomized controlled trial, we aimed to evaluate whether a novel mobile health intervention, HerBeatTM compared to Educational Usual Care, improved exercise capacity at 3 months among women with coronary heart disease. METHODS Women were randomized in a 1:1 ratio to the HerBeatTM group (n=23), a behavior change mobile health intervention with a smartphone, smartwatch, and health coach or to the Educational Usual Care group (n=24) that received a standardized cardiac rehabilitation workbook. Both groups received their usual health care throughout the study. The primary endpoint was exercise capacity measured with the six-minute walk test (6MWT). Secondary outcomes included changes in cardiovascular risk factors, and psychosocial well-being. RESULTS A total of 47 women (age 61.2 ± 9.1 years) underwent randomization. Retention in the study was 89% (42/47) at the 3-month follow-up. The HerBeat™ group improved exercise capacity from baseline to 3 months by 22.1 ± 39.5 meters and the Educational Usual Care group increased by 1.4 ± 46.3 meters on the 6MWT. The between group difference at 3 months of 38 meters (463.7 ± 71.9 meters vs 425.1 ± 92.6 meters) was not statistically significant. The HerBeat™ group significantly improved meters walked from baseline to 3 months (441.6 ± 57.7 meters to 463.7 ± 71.7 meters; P=.016, d=.558) while the Educational Usual Care group did not (423.8 ± 92.6 meters to 425.1 ± 92.6 meters; P=.894, d=-.030). The Educational Usual Care group and HerBeatTM group had similar improvements in secondary outcomes (all P >.05). The mean System Usability score for the HerBeatTM group was 82.0 ± 20.6 indicating that the participants viewed the system favorably. CONCLUSIONS The mobile health intervention led to greater improvements in exercise capacity from baseline to 3 months than the Educational Usual Care intervention. There was no statistically significant difference in exercise capacity between groups. The HerBeatTM intervention was feasible and acceptable with minimal attrition. The results of this trial support the feasibility and acceptability of conducting a large definitive randomized controlled trial. CLINICALTRIAL This study protocol was approved by the University of South Florida Institutional Review Board (PRO # 000400086). Because this study was primarily a pilot feasibility study, our Institutional Review Board did not believe this study was required to be registered at ClinicalTrials.gov. Therefore it was not registered. The reporting of this study was based on CONSORT (Consolidated Standards of Reporting Trials) guidelines.