Efficacy of an mHealth application (eMOTIVA) in compliance with cardiac rehabilitation guidelines in patients with coronary artery disease: A randomized controlled clinical trial (Preprint)

Abstract

Cardiac rehabilitation is fundamental among patients recovering from a coronary event, and mHealth technology may constitute a useful tool that provides guidelines based on scientific evidence in an entertaining, attractive, and user-friendly format.

To compare the efficacy of an mHealth intervention involving the eMOTIVA application and usual care regarding compliance with cardiac rehabilitation guidelines in terms of lifestyle, the control are cardiovascular risk factors and satisfaction among patients that had suffered from an acute coronary syndrome.

A randomized controlled clinical trial with parallel group design was conducted including 300 patients (150 control group and 150 mHealth group) who underwent a percutaneous coronary intervention with stent implantation after an acute coronary syndrome. Both groups were given an initial evaluation (during hospitalisation) and then after three and six months in a face-to-face consultation. The app incorporates a virtual classroom that provides audio and video information about a healthy lifestyle, a section for the self-recording of cardiovascular risk factors, feedback through personalised messages and gamification to motivate the user. The primary outcome variables were: 1) adherence to the Mediterranean diet and frequency of consumption each food group; 2) level of physical activity, sedentary time, and exercise capacity; 3) smoking cessation and nicotine dependence; 4) adherence to treatment; 4) level of knowledge acquired about cardiovascular risk factors; and 6) app satisfaction and usability.

The study analysed 287 patients, 145 in the mHealth group and 142 in the control group; most were male (69%), with a mean age of 62.53±8.65. Significant improvements were observed in the mHealth group with regard to the control group after six months in terms of: 1) adherence to the Mediterranean diet (11.92±1.70 vs 8.92±2.66, P<.001) and frequency of eating certain foods (red meat ≤ 1/week: 97.9% vs 68.1%, P<.001; industrial pastries <2/week: 89.6% vs 56.8%, P<.001; oily fish ≥2/week: 86.1% vs 41.4%, P<.001; vegetables ≥2/day: 90.3% vs 55.3%, P<.001 and fruit ≥2/day: 88.9% vs 60.2%, P<.001) 2) physical activity (2112.66±1196.67 MET/week vs 1372.60±944.62 MET/week, P<.001) and sedentary time (8.38±1.88 hours vs. 9.59±2.09 hours (P<.001) 3) exercise capacity (473.49±102.28 metres vs 447.25±93.68 metres, P=.04), 4) adherence to medication (7.94±0.45 points vs 7.49±1.13 points, P<.001) and 5) level of knowledge (117.85±3.83 points vs 111.00±7.11, P<.001). Satisfaction with the app was high (42.53±6.38 points) and its usability was rated as excellent (95.60±4.03 points).

The eMOTIVA app significantly improved the following: adherence to the Mediterranean diet and frequency of eating certain foods, physical activity, sedentary time, exercise capacity, adherence to medication, level of knowledge, systolic blood pressure, heart rate and blood sugar levels. Furthermore, the participants reported a high level of satisfaction with the app and rated its usability as excellent, so this innovative tool is very promising.

ClinicalTrials.gov NCT05247606, https://clinicaltrials.gov/study/NCT05247606