VIDA Mobile Health Cardiovascular Prevention Program

Status Completed

Clinical Trial Summary

The purpose of this study is to understand the effects of a mobile health cardiovascular prevention program in patients who have recently graduated from cardiac rehabilitation. The mobile health program will focus on promoting healthy lifestyles through the use of a mobile application (app), mobile physical activity monitor and a system of remote health coaching.

By testing a novel mHealth intervention focused on lifestyle modification, this trial will address a critical evidence gap in the care of patients after they graduate from CR. Many patients who graduate from traditional CR struggle with unhealthy lifestyles, and these patients currently have no lifestyle-based care strategies to help them. The results of this study have the potential to lead to new sustainable and resource-efficient, lifestyle-based preventive care strategies for patients with stable CVD.

Clinical Trial Description

This is a single-center, randomized trial designed to examine the hypothesis that a lifestyle-based mobile health cardiovascular disease (CVD) prevention program administered to graduates of a cardiac rehabilitation (CR) program will improve physical activity, body composition, fitness, and quality of life (QOL).

The investigators may enroll up to 52 men and women volunteers from a pool of graduates of the Duke Cardiac Rehabilitation Program who are initially eligible to participate in this study. Of the 52 men and women volunteers who may be initially consented, it is anticipated that a portion (potentially 30%) may drop out during the study timeline, and approximately 40 are expected to complete this study. Following informed consent and baseline testing, the participants will be randomized in a 3:1 fashion to receive VIDA's 12-week mHealth program focused on lifestyle modification through remote health coaching in order to improve physical activity, body composition, and fitness. The multi-domain mHealth intervention will mirror traditional CR programs by focusing primarily on a structured physical activity intervention within the context of a comprehensive lifestyle program. Physical activity will be monitored by Fitbits and will be integrated into VIDA's mHealth platform which will also include modules on physical activity, weight management, heart healthy diet, medication adherence, coping with a chronic disease, psychosocial management, and stress management/sleep. Health coaches will be used to guide patients through the 12-week program. All participants will undergo measures of physical activity, body composition, fitness, and QOL at baseline and at 12-weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02431546
Study type	Interventional
Source	Duke University
Contact
Status	Completed
Phase	N/A
Start date	July 2015
Completion date	March 20, 2017

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