Working With Veterans Organizations to Improve Blood Pressure

Not Applicable

Completed

Conditions: Hypertension

Interventions: Behavioral: Seminar
Behavioral: Peer Led

Registration Number: NCT00571038

Lead Sponsor: US Department of Veterans Affairs

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 404

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Seminar	Seminar	Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.
Peer Led	Peer Led	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Weight	9/16/2008-8/9/2010; baseline and 12 months	Mean/SE change in weight, measured in pounds (lbs)
Change in Diastolic Blood Pressure	9/16/2008-8/9/2010; baseline and 12 months	Mean/SE change in diastolic blood pressure
Non-Clinic Blood Pressure Checks	9/16/2008-8/9/2010; baseline and 12 months	% reporting non-clinic blood pressure (BP) checks at least once a month
Change in Number of Blood Pressure Medications	9/16/2008-8/9/2010; baseline and 12 months	Change in mean # of prescription blood pressure medications
Change in Medication Adherence	9/16/2008-8/9/2010; baseline and 12 months	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
Change in Self Efficacy	9/16/2008-8/9/2010; baseline and 12 months	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
Change in Health Status	9/16/2008-8/9/2010; baseline and 12 months	Response to the question "How would you rate your general health status?". Response options are scored as follows. 1. Excellent 2. Very Good 3. Good 4. Fair 5. Poor We report the change in health status from baseline to 12 months.
Change in Time Since Last Physician Visit	9/16/2008-8/9/2010; baseline and 12 months	Change in mean # of months since last visit to a physician
Change in Hypertension Attitudes	9/16/2008-8/9/2010; baseline and 12 months	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
Change in Satisfaction With Blood Pressure Treatment	9/16/2008-8/9/2010; baseline and 12 months	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)
Change in Sodium Intake	9/16/2008-8/9/2010; baseline and 12 months	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
Change in Patient Activation	9/16/2008-8/9/2010; baseline and 12 months	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)
Change in BMI	9/16/2008-8/9/2010; baseline and 12 months	Mean/SE change in Body Mass Index (BMI) (kg/m2)
Change in Daily Steps	9/16/2008-8/9/2010; baseline and 12 months	Mean/SE change in # of steps per day (self report)
Change in Fruit and Vegetable Intake	9/16/2008-8/9/2010; baseline and 12 months	Mean/SE change in # of servings per day; questions taken from the 2009 Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire
Change in Health Opinions	9/16/2008-8/9/2010; baseline and 12 months	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
Change in Hypertension Knowledge	9/16/2008-8/9/2010; baseline and 12 months	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
Change in Alcohol Use	9/16/2008-8/9/2010; baseline and 12 months	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
Change in Physical Activity Level	9/16/2008-8/9/2010; baseline and 12 months	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
Change in Social Support	9/16/2008-8/9/2010; baseline and 12 months	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