Randomized Controlled Trial of Group Prevention Coaching

NCT01838226 | Completed Results

• 1 other identifier: CRE 12-285
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Disease

Keywords

Chronic Disease; Prevention; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Risk of Fatal Coronary Event or Non-fatal MI

  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 Outcomes (2)

• Patient Activation Measure

  6 months

• Risk of Fatal Coronary Event or Non-fatal MI

  12 month

Study Arms (2)

Group Prevention Clinics

EXPERIMENTAL

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).

Behavioral: Problem Solving

Treatment as usual control

NO INTERVENTION

Usual VA care

Interventions

Problem Solving 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).

Group Prevention Clinics

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Any
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215-1129, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Related Publications (2)

• 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.

  PMID: 28600161 RESULT

• 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.

  PMID: 32913914 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. David Edelman
• Organization: Durham VAHCS HSR&D

david.edelman@va.gov

919-286-6936

Study Officials

• David Edelman, MD MHS

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 23, 2013
• Study Start: August 29, 2014
• Primary Completion: October 31, 2018
• Study Completion: April 30, 2019
• Last Updated: July 27, 2023
• Results First Posted: May 19, 2020

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2)