Randomized Controlled Trial of Group Prevention Coaching
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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). |
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: Treatment as usual control Usual VA care |
Outcome Measures
Primary Outcome Measures
- Risk of Fatal Coronary Event or Non-fatal MI [6 months]
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.
Secondary Outcome Measures
- Patient Activation Measure [6 months]
Measure of self-efficacy. Scored from 0-100, with 100 being higher self-efficacy and a better outcome.
- Risk of Fatal Coronary Event or Non-fatal MI [12 month]
The primary outcome will be 10-year risk of fatal coronary event or non-fatal MI 12 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.
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Western New York Healthcare System, Buffalo, NY | Buffalo | New York | United States | 14215 |
| 2 | Durham VA Medical Center, Durham, NC | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: David Edelman, MD MHS, Durham VA Medical Center, Durham, NC
Study Documents (Full-Text)
More Information
Publications
None provided.- CRE 12-285
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group Prevention Clinics | Treatment as Usual Control |
|---|---|---|
| Arm/Group Description | 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. 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). Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training. Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction). | Usual VA care |
| Period Title: Overall Study | ||
| STARTED | 202 | 199 |
| COMPLETED | 126 | 128 |
| NOT COMPLETED | 76 | 71 |
Baseline Characteristics
| Arm/Group Title | Group Prevention Clinics | Treatment as Usual Control | Total |
|---|---|---|---|
| Arm/Group Description | 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). | Usual VA care | Total of all reporting groups |
| Overall Participants | 202 | 199 | 401 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
62.9
(11.1)
|
61.9
(9.2)
|
62.4
(10.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
21
10.4%
|
19
9.5%
|
40
10%
|
| Male |
181
89.6%
|
180
90.5%
|
361
90%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
7
3.5%
|
4
2%
|
11
2.7%
|
| Not Hispanic or Latino |
195
96.5%
|
195
98%
|
390
97.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
60
29.7%
|
69
34.7%
|
129
32.2%
|
| White |
130
64.4%
|
116
58.3%
|
246
61.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
12
5.9%
|
14
7%
|
26
6.5%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
202
100%
|
199
100%
|
401
100%
|
| Framingham Risk Score (percent risk of event) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [percent risk of event] |
28.9
(15.2)
|
29.5
(17.2)
|
29.2
(16.2)
|
Outcome Measures
| Title | Risk of Fatal Coronary Event or Non-fatal MI |
|---|---|
| Description | 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. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group Prevention Clinics | Treatment as Usual Control |
|---|---|---|
| Arm/Group Description | 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. 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). Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training. Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction). | Usual VA care |
| Measure Participants | 202 | 199 |
| Mean (Standard Deviation) [percent risk of major cv event in 10 yrs] |
27.0
(17.2)
|
26.3
(15.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Prevention Clinics, Treatment as Usual Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.50 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.7 | |
| Confidence Interval |
(2-Sided) 95% -1.3 to 2.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Patient Activation Measure |
|---|---|
| Description | Measure of self-efficacy. Scored from 0-100, with 100 being higher self-efficacy and a better outcome. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group Prevention Clinics | Treatment as Usual Control |
|---|---|---|
| Arm/Group Description | 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. 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). Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training. Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction). | Usual VA care |
| Measure Participants | 202 | 199 |
| Mean (Standard Deviation) [units on a scale] |
62.1
(11.5)
|
62.6
(12.2)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Prevention Clinics, Treatment as Usual Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.9 | |
| Confidence Interval |
(2-Sided) 95% -1.3 to 3.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Risk of Fatal Coronary Event or Non-fatal MI |
|---|---|
| Description | The primary outcome will be 10-year risk of fatal coronary event or non-fatal MI 12 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. |
| Time Frame | 12 month |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group Prevention Clinics | Treatment as Usual Control |
|---|---|---|
| Arm/Group Description | 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. 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). Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training. Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction). | Usual VA care |
| Measure Participants | 202 | 199 |
| Mean (Standard Deviation) [percent risk of cv event in 10 years] |
25.7
(15.4)
|
28.2
(16.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group Prevention Clinics, Treatment as Usual Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -2.6 | |
| Confidence Interval |
(2-Sided) 95% -4.9 to -0.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | 12 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events were assessed without regard to specific adverse event terms. | |||
| Arm/Group Title | Group Prevention Clinics | Treatment as Usual Control | ||
| Arm/Group Description | 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. 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). Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training. Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction). | Usual VA care | ||
All Cause Mortality |
||||
| Group Prevention Clinics | Treatment as Usual Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/202 (0.5%) | 0/199 (0%) | ||
Serious Adverse Events |
||||
| Group Prevention Clinics | Treatment as Usual Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/202 (0.5%) | 0/199 (0%) | ||
| Cardiac disorders | ||||
| death | 1/202 (0.5%) | 1 | 0/199 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Group Prevention Clinics | Treatment as Usual Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/202 (0%) | 0/199 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. David Edelman |
|---|---|
| Organization | Durham VAHCS HSR&D |
| Phone | 919-286-6936 |
| david.edelman@va.gov |
- CRE 12-285