VIDA Mobile Health Cardiovascular Prevention Program
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/5/2017 |
| Start Date: | July 2015 |
| End Date: | March 20, 2017 |
A Lifestyle-Based Mobile Health Strategy for Cardiovascular Disease Prevention in Graduates From Cardiac Rehabilitation: VIDA Pilot Study
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.
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.
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.
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.
Inclusion Criteria:
- Graduates of CR, who were originally enrolled in CR following myocardial infarction
(MI), percutaneous coronary intervention (PCI), or coronary artery bypass graft
(CABG) or with stable angina
- Adequate clinical stability has been achieved in the judgment of the investigator to
allow participation in study assessments and the intervention
- Ability to participate in a mobile health program with access to smartphones
utilizing Apple and Android platforms
- Signed informed consent document indicating that the patient understands the purpose
of and procedures required for the study and is willing to participate in the study
Exclusion Criteria:
- Acute symptoms of coronary artery disease
- Decompensated heart failure
- Severe valvular heart disease
- Severe pulmonary hypertension
- End stage renal disease
- Heart failure, New York Heart Association (NYHA) class IV
- Cardiac transplantation
- Terminal illness with life expectancy < 1 year
- Impairment from stroke, injury or other medical disorder that precludes participation
in the intervention
- Dementia that precludes ability to participate in and follow study protocols
- Enrollment in a clinical trial not approved for co-enrollment
- Inability or unwillingness to comply with the study requirements
We found this trial at
1
site
Durham, North Carolina 27705
Principal Investigator: William E Kraus, MD
Phone: 919-660-6781
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