Enhancing Lifestyle Change in Cardiac Patients Through the Do CHANGE System (“Do Cardiac Health: Advanced New Generation Ecosystem”): Randomized Controlled Trial Protocol

Mirela Habibović,Eva Broers,Jordi Piera-Jimenez,Mart Wetzels,Johan Denollet,Jos Widdershoven,Idowu Ayoola

doi:10.2196/resprot.8406

Abstract

BackgroundPromoting a healthy lifestyle (eg, physical activity, healthy diet) is crucial for the primary and secondary prevention of cardiac disease in order to decrease disease burden and mortality.ObjectiveThe current trial aims to evaluate the effectiveness of the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) service, which is developed to assist cardiac patients in adopting a healthy lifestyle and improving their quality of life.MethodsCardiac patients (ie, people who have been diagnosed with heart failure, coronary artery disease, and/or hypertension) will be recruited at three pilot sites (Badalona Serveis Assistencials, Badalona, Spain [N=75]; Buddhist Tzu Chi Dalin General Hospital, Dalin, Taiwan [N=100] and Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands [N=75]). Patients will be assisted by the Do Something Different (DSD) program to change their unhealthy habits and/or lifestyle. DSD has been developed to increase behavioral flexibility and subsequently adopt new (healthier) habits. In addition, patients’ progress will be monitored with a number of (newly developed) devices (eg, Fitbit, Beddit, COOKiT, FLUiT), which will be integrated in one application.ResultsThe Do CHANGE trial will provide us with new insights regarding the effectiveness of the proposed intervention in different cultural settings. In addition, it will give insight into what works for whom and why.ConclusionsThe Do CHANGE service integrates new technologies into a behavior change intervention in order to change the unhealthy lifestyles of cardiac patients. The program is expected to facilitate long-term, sustainable behavioral change.Trial RegistrationClinicaltrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305 (Archived by WebCite at http://www.webcitation.org/6wfWHvuyU).

Highlights

Cardiovascular diseases are the leading cause of death worldwide and a major driver of health care costs [1]
In their recent call for action, the American Heart Association stressed the importance of lifestyle management and called for better lifestyle counseling and the development of interventions to support health behavior change in cardiac patients [5]
Patients primarily diagnosed with coronary artery disease (CAD), symptomatic heart failure (HF) (New York Heart Association class I-IV), and patients diagnosed with hypertension (HT) will be included in the study

Summary

Introduction

Cardiovascular diseases are the leading cause of death worldwide and a major driver of health care costs [1]. Evidence shows that a large proportion of the disease burden can be explained by behavioral factors (eg, low physical activity, unhealthy diet) [2], and that approximately 80% of heart disease, stroke, and type 2 diabetes can be prevented by attenuating or eliminating these health risk behaviors [3,4]. In their recent call for action, the American Heart Association stressed the importance of lifestyle management and called for better lifestyle counseling and the development of interventions to support health behavior change in cardiac patients [5]. Trial Registration: Clinicaltrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305 (Archived by WebCite at http://www.webcitation.org/6wfWHvuyU)

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Methods

Conclusion