VIDA Mobile Health Cardiovascular Prevention Program

January 31, 2018 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Medicine - Duke Molecular Physiology Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Health Application Group

VIDA is a mobile technology that is well positioned to provide healthcare coaching. After completing the CR program, each participant will have access to the VIDA mobile phone platform for the 12-week intervention, and be instructed to download the app on his/her smart phone. VIDA will assign an individual professional health coach selected from a pool of well-trained and experienced health professionals-nutritionists, fitness trainers, nurses and health educators. Each coach will engage their patient in a productive and meaningful health mentorship on a daily basis. The coach and patient work as a team to successfully set goals and make small changes that add up to significant improvements in the patients' dietary choices, physical activity, medication management, as well as understanding of their health status.

Physical Activity: A goal of "total number of steps" to attain daily will be provided by the Duke study team to the patient and monitored using a Fitbit activity tracker.
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.

Other Names:
  • Health Coaches
  • Physical Activity Tracker
No Intervention: Usual Care Group
Participants randomized to the usual care control arm will follow standard care as ordered by their individual, treating physician. Participants in the UC control arm will not receive any specific lifestyle recommendations from study personnel. They may, however, receive any lifestyle recommendations deemed appropriate by their usual clinical care providers. All participants will be contacted by study personnel in order to schedule visits at baseline and 12-weeks for the outcome assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fitness (peak VO2mL/kg/min) as measured by cardiopulmonary exercise test (CPET).
Time Frame: Baseline and 14-weeks
peak VO2mL/kg/min
Baseline and 14-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Understand the feasibility and implementation of this novel mhealth treatment strategy.
Time Frame: 14-weeks
Patient Satisfaction Survey
14-weeks
Change in Physical Activity as measured using a Fitbit
Time Frame: Baseline and 14-weeks
Total number of steps, distance traveled and floors climbed.
Baseline and 14-weeks
Change in Quality of Life (QOL) as measured by Seattle Angina Questionnaire (SAQ).
Time Frame: Baseline and 14-weeks
Baseline and 14-weeks
Change in Medication Adherence as measured by Morisky Medication Adherence Scale (MMAS-8).
Time Frame: Baseline and 14-weeks
Baseline and 14-weeks
Change in Body Mass
Time Frame: Baseline and 14-weeks
Weight
Baseline and 14-weeks
Change in Body Mass Index
Time Frame: Baseline and 14-weeks
Weight/Height (kg/m2)
Baseline and 14-weeks
Change in waist circumference
Time Frame: Baseline and 14-weeks
Minimal and Abdominal
Baseline and 14-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Vida Health, Inc.

Investigators

  • Principal Investigator: William E Kraus, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

March 20, 2017

Study Completion (Actual)

March 20, 2017

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 1, 2015

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00057493

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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