CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 401 enrolled
Drug / intervention
Problem Solvingbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01838226
NCT01838226N/ACompleted

Randomized Controlled Trial of Group Prevention Coaching

VA Office of Research and Development·interventional·Posted Apr 23, 2013·Updated Jul 27, 2023

In Brief

A clinical study evaluating Problem Solving for Cardiovascular Disease. Completed, enrolled 401 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 23, 2013
Enrollment StartAug 29, 2014
Primary CompletionOct 31, 2018
Study CompletionApr 30, 2019
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 13.2 years ago

Interventions

Problem Solvingbehavioral

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).