Using m-health and wearable technologies to promote self-management and treatment adherence among cardiovascular disease patients: a clinical trial protocol
Authors: Sousa P , Ferreira P , Ventura F , Dixe M , Martinho R , Dias S , Morais J , Goncalves L 
Published: July 2023

Abstract

Funding Acknowledgements
Type of funding sources: None.

Background
Cardiovascular diseases (CVD) are the leading cause of death globally, taking an estimated 17.9 million lives each year. Cardiac rehabilitation (CR) is shown to reduce mortality and hospital readmissions, while improving physical fitness and quality of life. Despite the recommendations and proven benefits, acceptance and adherence remain low. Mobile health (mHealth) solutions may contribute to more personalized and tailored patient recommendations according to their specific needs.

Purpose
The main goal of this research is to determine the effectiveness of an e-therapeutic intervention in improving the adherence to treatment and self-management of cardiovascular outpatients, and on the reduction of recurrent cardiovascular events.

Methods
The study follows a multicentre randomized controlled design involving two cardiology units in the Centre Region of Portugal. Participants will be cardiovascular outpatients older than 18 years of age, after the onset of acute cardiac event or those who are engaged in a structured CR program). Sample size was calculated and we estimate to recruit a sample of 330 patients, per arm. The intervention length will be 6 months, with the direct support of an interdisciplinary team. There will be two groups of treatment: control group and the experimental group (standard outpatient protocol plus the e-therapeutic program). The e-therapeutic kit includes mobile apps and wearables according to the patient needs and profile, such as heart rate, blood pressure, peripheral oxygen saturation (SpO2), sleep and step trackers, symptoms, lifestyle self-monitoring tools, medication reminders or motivational resources.
Outcomes: Outcome measurements will be carried out at the 3-month (T1) and the 6-month interventions (T2). The primary outcome will be the reduction of recurrent cardiovascular events, which is a composite of (i) cardiovascular rehospitalization or urgent visit; or (ii) unplanned revascularization; (iii) cardiovascular mortality; or (iv) worsening heart failure.
Secondary outcomes measures will include: a) Quality of Life; b) Adherence to treatment; c) Nutrition and Physical Activity; d) Anthropometric measures; e) cardiovascular risk (SCORE).

Conclusion
The success of the e-therapeutic intervention will be a step toward the use of technological interfaces as an integral part of CR programs. Altogether, these programmes are likely to facilitate the management of resources for healthcare professionals and reduce inequality of access to healthcare for CVD patients. In the western world healthcare systems, the complementarity of mHealth solutions to the treatment, care and rehabilitation along the chronic diseases pathway is mandatory if aiming for sustainable, integrated healthcare systems that endorse patient’s willingness to be part of their treatment journey, while assisting them at distance.