Working With Veterans Organizations to Improve Blood Pressure (POWER)
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Purpose
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 |
|---|---|
|
Hypertension |
Behavioral: Peer support meetings Behavioral: Educational presentations |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Working With Veterans Organizations to Improve Blood Pressure |
- Change in systolic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Self report of: diet, physical activity, adherence to medications, knowledge and attitudes about hypertension [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 404 |
| Study Start Date: | February 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
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 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.
|
|
Active Comparator: Arm 2
Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.
|
Behavioral: Educational presentations
Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 SBP greater than 140 or 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 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).
Contacts and Locations| United States, Wisconsin | |
| Clement J. Zablocki VAMC | |
| Milwaukee, Wisconsin, United States, 53295-1000 | |
| Principal Investigator: | Jeffrey C. Whittle, MD MPH | Clement J. Zablocki VAMC |
More Information
Additional Information:
Publications:
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00571038 History of Changes |
| Other Study ID Numbers: | IAB 06-086 |
| Study First Received: | December 7, 2007 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Hypertension Self-help groups Community health networks |
Health knowledge, attitudes, practice Patient participation Randomized clinical trial |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013