Working With Veterans Organizations to Improve Blood Pressure

Study Overview
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Brief Summary
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The primary purpose of this project is to establish the efficacy of a novel peer support intervention to reduce hypertension among members of veteran service organizations (VSOs). Specifically, we plan to demonstrate that veterans participating in a peer support intervention, as opposed to a purely didactic educational program, will have better blood pressure (BP) control, increased engagement in blood pressure lowering activities (such as exercise), and a more active stance as patients.

Detailed Description
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IMPACT ON VETERANS HEALTH It is anticipated that this intervention will help participating veterans achieve optimal hypertension (HTN) control. Doing so will reduce their risks for heart disease and stroke, and improve their quality of life. It is hoped that the collaborative nature of this intervention will strengthen the Department of Veterans Affairs (VA)'s ties to the veteran community, and establish important partnerships for health. If successful, this intervention could serve as a model for managing chronic disease both within and outside the VA system. BACKGROUND/RATIONALE Despite consensus that effective hypertension treatment reduces morbidity and mortality, many patients in the United States continue to have suboptimal blood pressure control. Even with the provider resources and motivated patients inherent in a randomized clinical trial, over a third of patients participating in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) were not at their goal blood pressure of 140/90 after five years. Similarly, within the Veterans Integrated Service Network (VISN) 12 we have found that as many as 30% of patients with hypertension are above the target BP of 140/90, despite routine physician reminders to patients who are above these goals. Moreover, preliminary results of an internally funded randomized trial suggest minimal impact of further physician-focused interventions to reduce patients' blood pressure. OBJECTIVES We will have two primary objectives. First, because the intervention proposed is novel, we believe we need to demonstrate its efficacy in a methodologically rigorous fashion. Specifically we plan to demonstrate that veterans participating in a peer support intervention will have improved blood pressure control, knowledge of blood pressure treatment, both generally and for themselves, and a more active stance as patients. Second, we will carefully examine the process by which our intervention achieves these goals, including examining such key structural variables as the frequency of peer support meetings, attendance of participants at these meetings, and use of healthcare professional support by the group leaders. As part of this second objective, we also seek to understand the fidelity with which the peer leaders are to deliver the intervention, and the satisfaction of both support group participants and leaders with the intervention. METHODS There are three primary activities in the present project. First, academicians from the Clement J. Zablocki VA Medical Center (VAMC) are working with the Veterans of Foreign Wars (VFW) and other community groups to develop a community-academic partnership that follows the principles of community-based participatory research. This key activity is underway and will continue beyond the present period of funding. Second, the centerpiece of the present grant is a cluster randomized clinical trial (RCT) of the use of peer-led support groups to improve BP control in patients with hypertension. Fifty posts drawn from the VFW, American Legion, Vietnam Veterans Association, and National Association of Black Veterans will be randomly assigned to receive professionally delivered education regarding hypertension or to a peer support intervention. The third activity is an evaluation of the processes involved in delivering the peer support intervention that will allow for successful replication, or to provide insight into why the expected improvement in BP control did not occur.

Official Title
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Working With Veterans Organizations to Improve Blood Pressure

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Peer Led
* Behavioral: Seminar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Member of a post or auxiliary of a participating veterans' service organization or Elks Lodge in the 70 miles surrounding the Milwaukee VAMC. Hypertension as established by one of: a) Average systolic blood pressure (SBP) greater than 140 or diastolic blood pressure (DBP) greater than 90 at two baseline visits; b) SBP greater than 130 or DBP greater than 90 at two baseline visits, plus patient report of diabetes mellitus and use of a hypoglycemic agent at the baseline visit; or c) self-reported hypertension plus self-reported current treatment with at least one antihypertensive drug at baseline visit. Willingness to sign informed consent document. Exclusion Criteria: Medical or social condition preventing routine attendance at a monthly meeting. Inability to communicate with other post members because of language barrier or physical limitation (e.g., prior stroke).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer Led<br>Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members. | Behavioral: Peer Led<br>* Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.<br>* Other names: Peer led education and support;|
| Active Comparator: Seminar<br>Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. | Behavioral: Seminar<br>* Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.<br>* Other names: Professional didactic education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure | Mean/Standard Error (SE) change in systolic blood pressure | 9/16/2008-8/9/2010; baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diastolic Blood Pressure | Mean/SE change in diastolic blood pressure | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Weight | Mean/SE change in weight, measured in pounds (lbs) | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in BMI | Mean/SE change in Body Mass Index (BMI) (kg/m2) | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Health Status | Response to the question How would you rate your general health status?. Response options are scored as follows. Excellent Very Good Good Fair Poor We report the change in health status from baseline to 12 months. | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Time Since Last Physician Visit | Change in mean # of months since last visit to a physician | 9/16/2008-8/9/2010; baseline and 12 months | 
| Non-Clinic Blood Pressure Checks | % reporting non-clinic blood pressure (BP) checks at least once a month | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Number of Blood Pressure Medications | Change in mean # of prescription blood pressure medications | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Hypertension Knowledge | Mean/SE change in score on: Scale: Hypertension Evaluation of Lifestyle and Management (HELM) Construct: Knowledge of hypertension and lifestyle factors related to hypertension Minimum Score: 0 Maximum Score: 14 Interpretation of Score: Higher is better | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Hypertension Attitudes | Mean/SE change in score on: Scale: Not applicable; series of agree/disagree statements that we wrote Construct: Attitudes around blood pressure diagnosis, treatment (including lifestyle changes), and seriousness of the condition Minimum Score: 12 Maximum Score: 60 Interpretation of Score: Lower is better | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Satisfaction With Blood Pressure Treatment | Mean/SE change in score on: Scale: Modified Holmes-Ravnor Satisfaction with Decision (SWD) Construct: Satisfaction with current blood pressure treatment Minimum Score: 1 Maximum Score: 5 Interpretation of Score: Lower is better (NOTE: Original instrument's scoring is reversed; i.e., higher is better) | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Alcohol Use | Mean/SE change in score on: Scale: Alcohol Use Disorders Identification Test (AUDIT) Construct: Alcohol use and abuse Minimum Score: 0 Maximum Score: 12 Interpretation of Score: Lower is better | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Sodium Intake | Mean/SE change in score on: Scale: Hopkins Dietary Questionnaire (only the dietary salt avoidance questions) Construct: Dietary sodium intake Minimum Score: 2 Maximum Score: 12 Interpretation of Score: Higher is better | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Physical Activity Level | Mean/SE change in score on: Scale: International Physical Activity Questionnaire (IPAQ), Metabolic Equivalent of Task (MET) Construct: Total metabolic equivalents (a measure of energy expenditure) in the last 7 days Minimum Score: 0 Maximum Score: Not applicable; based on physical activity done Interpretation of Score: Higher is better | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Daily Steps | Mean/SE change in # of steps per day (self report) | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Fruit and Vegetable Intake | Mean/SE change in # of servings per day; questions taken from the 2009 Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Medication Adherence | Mean/SE change in score on: Scale: Morisky Adherence; questions modified to ask specifically about blood pressure medication Construct: Adherence to prescribed medication-taking regimen Minimum Score: 0 Maximum Score: 4 Interpretation of Score: Lower is better | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Self Efficacy | Mean/SE change in score on: Scale: Schwarzer General Perceived Self-Efficacy Construct: Perceived self-efficacy Minimum Score: 10 Maximum Score: 40 Interpretation of Score: Higher is better | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Social Support | Mean/SE change in overall score on: Scale: Medical Outcomes Study (MOS) Social Support Survey Construct: Overall measure of social support, including tangible, affectionate, positive social interaction, and emotional/informational Minimum Score: 0 Maximum Score: 100 Interpretation of Score: Higher is better | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Health Opinions | Mean/SE change in overall score on: Scale: Krantz Health Opinion Survey Construct: Opinions about healthcare and healthcare providers Minimum Score: 0 Maximum Score: 16 Interpretation of Score: Higher is better | 9/16/2008-8/9/2010; baseline and 12 months | 
| Change in Patient Activation | Mean/SE change in score on: Scale: Hibbard Patient Activation Measure (PAM) Construct: Level of patient activation and engagement in health care Minimum Score: 0 Maximum Score: 100 Interpretation of Score: Lower is better (NOTE: Original instrument's scoring is reversed; i.e., higher is better) | 9/16/2008-8/9/2010; baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Self-help groups, Community health networks, Health knowledge, attitudes, practice, Patient participation, Randomized clinical trial