Ignite Creation Date:
2024-05-06 @ 4:02 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02431546
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2015-04-28
Brief Title:
VIDA Mobile Health Cardiovascular Prevention Program
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Lifestyle-Based Mobile Health Strategy for Cardiovascular Disease Prevention in Graduates From Cardiac Rehabilitation VIDA Pilot Study
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 31 fashion to receive VIDAs 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 VIDAs 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 managementsleep 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
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 31 fashion to receive VIDAs 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 VIDAs 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 managementsleep 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None