Randomized Controlled Trial of Group Prevention Coaching

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01838226
First received: April 18, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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. Our 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; we will also assess improvements in food choice, physical activity and weight


Condition Intervention Phase
Cardiovascular Disease
Behavioral: Problem Solving
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Randomized Controlled Trial of Group Prevention Coaching

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Risk of fatal coronary event or non-fatal MI [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • International Physical Activity Questionnaire [ Time Frame: 6 mos ] [ Designated as safety issue: No ]
    self-reported measure of physical activity

  • Block Brief 2000 Food Frequency Questionnaire [ Time Frame: 6 mos ] [ Designated as safety issue: No ]
    self-reported dietary intake

  • Patient Activation Measure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measure of self-efficacy

  • Connor-Davidson Resilience Scale [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Measure of resilience to stressful occurrences


Estimated Enrollment: 400
Study Start Date: May 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
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).
Behavioral: 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).
No Intervention: Control
Usual VA care

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. We 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. We 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. We will also determine if group cohesion, as measured by the Group Dynamics Inventory, influences the effectiveness of GPC. We well also assess whether time spent in contact with a coach influences the effectiveness, by database log-in timekeeping strategies.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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)
  • or diabetes (codes 250.x)
  • or use of a medication in formulary classes OH501 or OH502 (diabetic medications)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838226

Contacts
Contact: Amy C Harris (919) 286-0411 ext 5649 amy.harris1@va.gov
Contact: Dana C Tucker, BA (919) 286-0411 ext 5741 dana.tucker@va.gov

Locations
United States, New York
VA Western New York Healthcare System, Buffalo, NY Not yet recruiting
Buffalo, New York, United States, 14215
Contact: Laura Wray, PhD    716-862-8598    laura.wray@va.gov   
United States, North Carolina
Durham VA Medical Center Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: David Edelman, MD MHS    (919) 286-6936    david.edelman@va.gov   
Sub-Investigator: Corrine I. Voils, PhD         
Principal Investigator: David Edelman, MD MHS         
Sub-Investigator: George Lee Jackson, PhD MHA         
Sponsors and Collaborators
Investigators
Principal Investigator: David Edelman, MD MHS Durham VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01838226     History of Changes
Other Study ID Numbers: CRE 12-285
Study First Received: April 18, 2013
Last Updated: April 14, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Chronic Disease
Prevention
cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014