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Sponsors and Collaborators: |
Department of Veterans Affairs Medical College of Wisconsin Veterans of Foreign Wars Vietnam Veterans of America National Association of Black Veterans Wisconsin Elks Association Korean War Veterans of America Disabled American Veterans AmVETS Jewish War Veterans of the U.S.A. |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | 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 control, increased engagement in blood pressure lowering activities (such as exercise), and a more active stance as patients.
Condition | Intervention |
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Hypertension |
Behavioral: Peer support meetings Behavioral: Educational presentations |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Working With Veterans Organizations to Improve Blood Pressure |
Estimated Enrollment: | 600 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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.
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Behavioral: Peer support meetings
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.
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2: Active Comparator
Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.
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Behavioral: Educational presentations
Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.
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IMPACT ON VETERANS HEALTH It is anticipated that this intervention will help participating veterans achieve optimal hypertension 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 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 (BP) control. Even with the provider resources and motivated patients inherent in a randomized clinical trial, over a third of patients participating in the ALLHAT study were not at their goal blood pressure of 140/90 after five years. Similarly, within 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 Zablocki VA are working with the 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 Veterans of Foreign Wars, 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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kristyn M Ertl, BA | (414) 384-2000 ext 46441 | kristyn.ertl@va.gov |
Contact: Jeffrey C Whittle, MD MPH | (414) 384-2000 ext x46441 | Jeffrey.Whittle@va.gov |
United States, Wisconsin | |
Clement J. Zablocki VAMC | Recruiting |
Milwaukee, Wisconsin, United States, 53295-1000 | |
Contact: Kristyn M Ertl, BA 414-384-2000 ext 46441 kristyn.ertl@va.gov | |
Contact: Jeffrey C Whittle, MD MPH (414) 384-2000 ext x46441 Jeffrey.Whittle@va.gov | |
Principal Investigator: Jeffrey C. Whittle, MD MPH |
Principal Investigator: | Jeffrey C. Whittle, MD MPH | Clement J. Zablocki VAMC |
Responsible Party: | Department of Veterans Affairs ( Whittle, Jeffrey - Principal Investigator ) |
Study ID Numbers: | IAB 06-086 |
Study First Received: | December 7, 2007 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00571038 |
Health Authority: | United States: Federal Government |
Hypertension Self-help groups Community health networks |
Health knowledge, attitudes, practice Patient participation Randomized clinical trial |
Vascular Diseases Mineral Oil Hypertension |
Cardiovascular Diseases |