VIDA Mobile Health Cardiovascular Prevention Program
A Lifestyle-Based Mobile Health Strategy for Cardiovascular Disease Prevention in Graduates From Cardiac Rehabilitation: VIDA Pilot Study
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2015
CompletedFirst Posted
Study publicly available on registry
May 1, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2017
CompletedFebruary 5, 2018
January 1, 2018
1.7 years
April 28, 2015
January 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in fitness (peak VO2mL/kg/min) as measured by cardiopulmonary exercise test (CPET).
peak VO2mL/kg/min
Baseline and 14-weeks
Secondary Outcomes (7)
Understand the feasibility and implementation of this novel mhealth treatment strategy.
14-weeks
Change in Physical Activity as measured using a Fitbit
Baseline and 14-weeks
Change in Quality of Life (QOL) as measured by Seattle Angina Questionnaire (SAQ).
Baseline and 14-weeks
Change in Medication Adherence as measured by Morisky Medication Adherence Scale (MMAS-8).
Baseline and 14-weeks
Change in Body Mass
Baseline and 14-weeks
- +2 more secondary outcomes
Study Arms (2)
Mobile Health Application Group
EXPERIMENTALVIDA 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.
Usual Care Group
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Vida Health, Inc.collaborator
Study Sites (1)
Duke Medicine - Duke Molecular Physiology Institute
Durham, North Carolina, 27705, United States
Related Publications (1)
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.
PMID: 29754647DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William E Kraus, MD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2015
First Posted
May 1, 2015
Study Start
July 1, 2015
Primary Completion
March 20, 2017
Study Completion
March 20, 2017
Last Updated
February 5, 2018
Record last verified: 2018-01