- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01838226
Randomized Controlled Trial of Group Prevention Coaching
July 19, 2023 updated by: VA Office of Research and Development
Prevention of cardiovascular disease is a primary focus of the Secretary's New Models of Care Transformational Initiative.
However, prevention has been hard to accomplish.
The VA is committed to using group visits to address a wide array of primary care problems.
Coaching is a method to help Veterans set and reach health goals by helping them overcome barriers to behavior change.
Coaching can be performed one-on-one or in groups.
This study will test the effectiveness of a group prevention coaching (GPC) intervention in improving cardiovascular risk.
GPCs will focus on changing a behavior of the patient's choice that is likely to lead to improvements in heart disease risk.
The coach will adopt a problem-solving approach to helping Veterans make these improvements.
The primary outcome will be change in 10-year risk of major cardiac event; the investigators will also assess improvements in food choice, physical activity and weight.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cardiovascular (CV) event prevention (e.g., myocardial infarction, cerebrovascular accident) remains the single most important public health problem in the United States, and cardiovascular disease is a leading cause of death among VA users.
Improving the provision of prevention services is a primary focus of the Secretary's New Models of Care Transformational Initiative.
However, prevention has been challenging to achieve.
Multifactorial behavioral interventions are effective in treating a number of chronic illnesses (e.g., hypertension, diabetes), but less is known about their ability to reduce risk among patients without a unifying chronic illness.
Group visits are an efficient, effective strategy for delivering a multifactorial behavior change intervention; the VA is committed to the group visit strategy to address a wide array of primary care problems.
Groups have been shown to be an effective means of improving a number of outcomes in a number of individual diseases, but, again, their role in cardiovascular prevention among patients without a single common illness is unknown.
Coaching is a type of multi-factorial behavioral intervention that involves goal-setting, and working to overcome barriers to behavior change.
Coaching can be performed one-on-one, but coaching interventions have been delivered in group settings.
The investigators have shown, in a 150-subject RCT, that group coaching plus individualized telephone coaching reduces cardiovascular risk, but the population in that study was very different from typical VA users.
The investigators propose a three-site, two-arm randomized trial measuring the effectiveness of a group prevention coaching (GPC) intervention in improving cardiovascular risk, compared to VA usual care.
The study will be performed at the Durham, Buffalo, and Syracuse VAMCs.
Each arm will have 200 patients; patients will be VA users without prior history of cardiovascular event, but with at least 5% risk of such an event, and with either inadequately controlled hypertension or dyslipidemia, or current smoking.
The GPC intervention will focus on changing a behavior of the patient's choice that is likely to lead to improvements in cholesterol, blood pressure, or to smoking cessation.
Behaviors that will be reinforced will include but not be limited to healthy eating, decreased caloric intake, increased physical activity, stress reduction, and participatory decision making with physicians.
Barriers to these behaviors will be identified.
The coach will adopt a problem-solving approach to overcoming the above barriers and reinforcing the above behaviors; problem-solving is a well-described framework for behavior change.
The GPC coach/interventionist for will be either the facility's Health Behavior Coordinator (HBC) or a person hired for the research enterprise but trained and credentialed identically to an HBC.
All outcomes will be obtained at baseline, 6, and 12 months after enrollment by blinded research personnel.
The primary outcome will be change in 10-year risk of fatal coronary event or non-fatal MI 6 months after enrollment, as measured by Framingham Risk Score.
Key secondary outcomes will include dietary content by Food Frequency Questionnaire, physical activity as measured by International Physical Activity Questionnaire, and weight.
The investigators will also determine if group cohesion, as measured by the Group Dynamics Inventory, influences the effectiveness of GPC.
The investigators well also assess whether time spent in contact with a coach influences the effectiveness, by database log-in timekeeping strategies.
Study Type
Interventional
Enrollment (Actual)
401
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
-
-
New York
-
Buffalo, New York, United States, 14215-1129
- VA Western New York Healthcare System, Buffalo, NY
-
-
North Carolina
-
Durham, North Carolina, United States, 27705-3875
- Durham VA Medical Center, Durham, NC
-
-
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
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
A diagnosis of inadequately controlled hypertension, as defined by an outpatient ICD-9 code of 401.x and a most recent blood pressure with either systolic > 140 mmHg or diastolic > 90 mmHg
- OR (2) inadequately controlled dyslipidemia, as defined by most recent total cholesterol > 200 mg/dl or HDL cholesterol < 35 mg/dl
- OR (3) current smoking, which can be identified using the CPRS Health Factor tied to the smoking clinical reminder.
- Medication-taking status for these illnesses is neither required nor excluded.
Exclusion Criteria:
- Subjects with very high risk of cardiovascular event, as determined by any personal history of coronary artery disease (CAD) or other major cardiovascular disease (ICD-9 code of 410-414, or 425-429)
- cerebrovascular disease (code 433-438)
- peripheral arterial disease (codes 440.x or 443.x)
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group Prevention Clinics
A group problem-solving intervention, with interval phone calls delivered to check in on goal progress and reinforce group learning.
Groups will meet monthly for 6 months, and each patient will be called once between each group session.
Each group will consist of 10 patients.
Problem-solving teaches patients to overcome internal barriers to healthful behaviors.
Problem solving will be combined, at all group sessions, with self-efficacy training, so that patients will be taught simultaneously to overcome both internal and external barriers.
Participants will be asked to develop personal goals related to cardiovascular disease (CVD)-related behaviors (e.g., smoking and weight reduction).
|
A group problem-solving intervention, with interval phone calls delivered to check in on goal progress and reinforce group learning.
Groups will meet monthly for 6 months, and each patient will be called once between each group session.
Each group will consist of 10 patients.
Problem-solving teaches patients to overcome internal barriers to healthful behaviors.
Problem solving will be combined, at all group sessions, with self-efficacy training, so that patients will be taught simultaneously to overcome both internal and external barriers.
Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction).
|
No Intervention: Treatment as usual control
Usual VA care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk of Fatal Coronary Event or Non-fatal MI
Time Frame: 6 months
|
The primary outcome will be 10-year risk of fatal coronary event or non-fatal MI 6 months after enrollment, as measured by Framingham Risk Score.
Scores range from 0 - 100, as this is a percentage of risk.
Higher scores are worse, as they represent higher risk.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Activation Measure
Time Frame: 6 months
|
Measure of self-efficacy.
Scored from 0-100, with 100 being higher self-efficacy and a better outcome.
|
6 months
|
Risk of Fatal Coronary Event or Non-fatal MI
Time Frame: 12 month
|
The primary outcome will be 10-year risk of fatal coronary event or non-fatal MI 12 months after enrollment, as measured by Framingham Risk Score.
Scores range from 0 - 100, as this is a percentage of risk.
Higher scores are worse, as they represent higher risk.
|
12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David Edelman, MD MHS, Durham VA Medical Center, Durham, NC
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
- Nieuwsma JA, Wray LO, Voils CI, Gierisch JM, Dundon M, Coffman CJ, Jackson GL, Merwin R, Vair C, Juntilla K, White-Clark C, Jeffreys AS, Harris A, Owings M, Marr J, Edelman D. A problem-solving intervention for cardiovascular disease risk reduction in veterans: Protocol for a randomized controlled trial. Contemp Clin Trials. 2017 Sep;60:42-50. doi: 10.1016/j.cct.2017.06.001. Epub 2017 Jun 23.
- Olsen MK, Stechuchak KM, Hung A, Oddone EZ, Damschroder LJ, Edelman D, Maciejewski ML. A data-driven examination of which patients follow trial protocol. Contemp Clin Trials Commun. 2020 Aug 13;19:100631. doi: 10.1016/j.conctc.2020.100631. eCollection 2020 Sep.
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 (Actual)
August 29, 2014
Primary Completion (Actual)
October 31, 2018
Study Completion (Actual)
April 30, 2019
Study Registration Dates
First Submitted
April 18, 2013
First Submitted That Met QC Criteria
April 18, 2013
First Posted (Estimated)
April 23, 2013
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 19, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRE 12-285
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
fully deidentified data will be shared as resources allow.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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