Randomized Controlled Trial of Group Prevention Coaching

NCT ID: NCT01838226

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 401 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-29
• Study Completion Date: 2019-04-30

Brief 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.

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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Problem Solving

Intervention Type: BEHAVIORAL

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).

Treatment as usual control

Usual VA care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Problem Solving

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).

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Edelman, MD MHS

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Locations

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 28600161 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32913914 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CRE 12-285

Identifier Type: -

Identifier Source: org_study_id