N/A
N=401
Randomized Controlled Trial of Group Prevention Coaching
Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT01838226 ↗Enrolled (actual)
401
Serious AEs
0.3%
Results posted
May 2020
Primary outcome: Primary: Risk of Fatal Coronary Event or Non-fatal MI — 27.0; 26.3 percent risk of major cv event in 10 yrs — p=0.50
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Problem Solving (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Risk of Fatal Coronary Event or Non-fatal MI |
25.7; 28.2 | — |
| SECONDARY Patient Activation Measure |
62.1; 62.6 | — |
| SECONDARY Risk of Fatal Coronary Event or Non-fatal MI |
25.7; 28.2 | — |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01838226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.