Coronary Artery DiseaseNCT02431546
VIDA Mobile Health Cardiovascular Prevention Program
A study testing Mobile Health Application in people with Coronary Artery Disease, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Mobile Health Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 20 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Medicine - Duke Molecular Physiology Institute
Durham, North Carolina, 27705
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Mobile Health Application
- Keywords
- Cardiology, Vascular, CAD, Duke, Cardiac Rehabilitation, Prevention, CVD, Mobile Health, Exercise
- Medical subject headings
- Coronary Artery Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health ApplicationBehavioural
Also called Health Coaches, Physical Activity Tracker
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Health Application Group | Experimental | 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. Receives: Behavioral: Mobile Health Application |
| Usual Care Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in fitness (peak VO2mL/kg/min) as measured by cardiopulmonary exercise test (CPET).
peak VO2mL/kg/min
Measured: Baseline and 14-weeks
Secondary outcomes (7)
Understand the feasibility and implementation of this novel mhealth treatment strategy.
Patient Satisfaction Survey
Measured: 14-weeks
Change in Physical Activity as measured using a Fitbit
Total number of steps, distance traveled and floors climbed.
Measured: Baseline and 14-weeks
Change in Quality of Life (QOL) as measured by Seattle Angina Questionnaire (SAQ).
Measured: Baseline and 14-weeks
Change in Medication Adherence as measured by Morisky Medication Adherence Scale (MMAS-8).
Measured: Baseline and 14-weeks
Change in Body Mass
Weight
Measured: Baseline and 14-weeks
Change in Body Mass Index
Weight/Height (kg/m2)
Measured: Baseline and 14-weeks
Change in waist circumference
Minimal and Abdominal
Measured: Baseline and 14-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startJul 2015
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Vida Health, Inc.
- Responsible party
- Sponsor
- Investigators
- William E Kraus, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431546
- Sponsor's protocol ID
- Pro00057493
- Status last verified
- Jan 2018
- First submitted
- 28 Apr 2015
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29754647
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Lifestyle-Based Mobile Health Strategy for Cardiovascular Disease Prevention in Graduates From Cardiac Rehabilitation: VIDA Pilot Study
- ClinicalTrials.gov ID
- NCT02431546
- Acronym / sponsor ID
- Pro00057493
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiology, Vascular, CAD, Duke, Cardiac Rehabilitation, Prevention, CVD, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Vida Health, Inc.
- Study start
- Jul 2015
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Health Application Group | Experimental | Behavioral: Mobile Health ApplicationVIDA 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 intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Acute symptoms of coronary artery disease
- Decompensated heart failure
- Severe valvular heart disease
- Severe pulmonary hypertension
- End stage renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health ApplicationAlso: Health Coaches, Physical Activity TrackerHealth 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. | Behavioural | Mobile Health Application Group |
Primary outcome
Change in fitness (peak VO2mL/kg/min) as measured by cardiopulmonary exercise test (CPET).
Time frame: Baseline and 14-weeks
peak VO2mL/kg/min
7 secondary outcomes
Understand the feasibility and implementation of this novel mhealth treatment strategy.
Time frame: 14-weeks
Change in Physical Activity as measured using a Fitbit
Time frame: Baseline and 14-weeks
Change in Quality of Life (QOL) as measured by Seattle Angina Questionnaire (SAQ).
Time frame: Baseline and 14-weeks
Change in Medication Adherence as measured by Morisky Medication Adherence Scale (MMAS-8).
Time frame: Baseline and 14-weeks
Change in Body Mass
Time frame: Baseline and 14-weeks
Change in Body Mass Index
Time frame: Baseline and 14-weeks
Change in waist circumference
Time frame: Baseline and 14-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Derived from this study: PubMed 29754647Duscha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William E Kraus, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health Application in people with Coronary Artery Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fitness (peak VO2mL/kg/min) as measured by cardiopulmonary exercise test (CPET). (time frame: Baseline and 14-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02431546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.