VIDA Mobile Health Cardiovascular Prevention Program

Coronary Artery Disease Clinical Trial

Official title:

A Lifestyle-Based Mobile Health Strategy for Cardiovascular Disease Prevention in Graduates From Cardiac Rehabilitation: VIDA Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431546
• Other study ID #: Pro00057493
• Status: Completed
• Phase: N/A
• First received: April 28, 2015
• Last updated: January 31, 2018
• Start date: July 2015
• Est. completion date: March 20, 2017

Study information

• Verified date: January 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 20, 2017
• Est. primary completion date: March 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• Mobile Health Application
Health coaching is an innovative, holistic approach oriented towards one's full health and wellbeing. Coaches provide mentoring and support regarding many areas of life that impact one's health with a focus on skill-building. Health coaches do not provide medical advice, treat any medical conditions, provide mental health therapy, or provide individualized assessments of nutrient needs. Health coaches will not conduct medication counseling activities that would alter the prescribed regimen nor provide medication information/advice that would be considered the practice of medicine or pharmacy. A Fitbit activity monitor will be used to track daily physical activity and provide real-time feedback to the participant.

Locations

Country	Name	City	State
United States	Duke Medicine - Duke Molecular Physiology Institute	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Vida Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fitness (peak VO2mL/kg/min) as measured by cardiopulmonary exercise test (CPET).	peak VO2mL/kg/min	Baseline and 14-weeks
Secondary	Understand the feasibility and implementation of this novel mhealth treatment strategy.	Patient Satisfaction Survey	14-weeks
Secondary	Change in Physical Activity as measured using a Fitbit	Total number of steps, distance traveled and floors climbed.	Baseline and 14-weeks
Secondary	Change in Quality of Life (QOL) as measured by Seattle Angina Questionnaire (SAQ).		Baseline and 14-weeks
Secondary	Change in Medication Adherence as measured by Morisky Medication Adherence Scale (MMAS-8).		Baseline and 14-weeks
Secondary	Change in Body Mass	Weight	Baseline and 14-weeks
Secondary	Change in Body Mass Index	Weight/Height (kg/m2)	Baseline and 14-weeks
Secondary	Change in waist circumference	Minimal and Abdominal	Baseline and 14-weeks