Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-1000, United States
NCT Number: NCT00571038
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.
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Interventional
Not applicable
Milwaukee, Wisconsin, 53295-1000, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Peer led education and support
Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.
Other names: Professional didactic education
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Mean/Standard Error (SE) change in systolic blood pressure
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Mean/SE change in diastolic blood pressure
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Mean/SE change in weight, measured in pounds (lbs)
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Mean/SE change in Body Mass Index (BMI) (kg/m2)
Time frame: 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.
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in mean # of months since last visit to a physician
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
% reporting non-clinic blood pressure (BP) checks at least once a month
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Change in mean # of prescription blood pressure medications
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 9/16/2008-8/9/2010; baseline and 12 months
Mean/SE change in # of steps per day (self report)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
US Department of Veterans Affairs
Fed
Acronym: POWER
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