Clinical trial NCT02431546: VIDA Mobile Health Cardiovascular Prevention Program
Official title: A Lifestyle-Based Mobile Health Strategy for Cardiovascular Disease Prevention in Graduates From Cardiac Rehabilitation: VIDA Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Cardiology
Vascular
CAD
Duke
Cardiac Rehabilitation
Prevention
CVD
Mobile Health
Exercise
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Vida Health, Inc.
First posted: 2015-05-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in fitness (peak VO2mL/kg/min) as measured by cardiopulmonary exercise test (CPET).
timeFrame: Baseline and 14-weeks
Secondary outcomes:
measure: Understand the feasibility and implementation of this novel mhealth treatment strategy.
timeFrame: 14-weeks
measure: Change in Physical Activity as measured using a Fitbit
timeFrame: Baseline and 14-weeks
measure: Change in Quality of Life (QOL) as measured by Seattle Angina Questionnaire (SAQ).
timeFrame: Baseline and 14-weeks
measure: Change in Medication Adherence as measured by Morisky Medication Adherence Scale (MMAS-8).
timeFrame: Baseline and 14-weeks
measure: Change in Body Mass
timeFrame: Baseline and 14-weeks
measure: Change in Body Mass Index
timeFrame: Baseline and 14-weeks
measure: Change in waist circumference
timeFrame: Baseline and 14-weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Medicine - Duke Molecular Physiology Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: William E Kraus, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duscha BD, Piner LW, Patel MP, Craig KP, Brady M, McGarrah RW 3rd, Chen C, Kraus WE. Effects of a 12-week mHealth program on peak VO2 and physical activity patterns after completing cardiac rehabilitation: A randomized controlled trial. Am Heart J. 2018 May;199:105-114. doi: 10.1016/j.ahj.2018.02.001. Epub 2018 Feb 7.