Working With Veterans Organizations to Improve Blood Pressure

NCT ID: NCT00571038

Last Updated: 2015-04-24

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-12-31

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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Peer Led

Intervention Type BEHAVIORAL

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.

Seminar

Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.

Group Type ACTIVE_COMPARATOR

Seminar

Intervention Type BEHAVIORAL

Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.

Interventions

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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.

Intervention Type BEHAVIORAL

Seminar

Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.

Intervention Type BEHAVIORAL

Other Intervention Names

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Peer led education and support Professional didactic education

Eligibility Criteria

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Inclusion Criteria

1. Member of a post or auxiliary of a participating veterans' service organization or Elks Lodge in the 70 miles surrounding the Milwaukee VAMC.
2. 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.
3. Willingness to sign informed consent document.

Exclusion Criteria

1. Medical or social condition preventing routine attendance at a monthly meeting.
2. Inability to communicate with other post members because of language barrier or physical limitation (e.g., prior stroke).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role collaborator

Veterans of Foreign Wars USA

OTHER

Sponsor Role collaborator

Vietnam Veterans of America

UNKNOWN

Sponsor Role collaborator

National Association of Black Veterans

UNKNOWN

Sponsor Role collaborator

Korea Veterans of America, Inc.

OTHER

Sponsor Role collaborator

Disabled American Veterans

OTHER

Sponsor Role collaborator

AmVETS

UNKNOWN

Sponsor Role collaborator

Jewish War Veterans of the United States of America

OTHER

Sponsor Role collaborator

The American Legion Department of Wisconsin

OTHER

Sponsor Role collaborator

Wisconsin Elks Association (a branch of The Benevolent and Protective order of Elks of the United States of America)

UNKNOWN

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey C Whittle, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Locations

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Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Rosenwald K, Ertl K, Fletcher KE, Whittle J. Patterns of arthritis medication use in a community sample. J Prim Care Community Health. 2012 Oct 1;3(4):272-7. doi: 10.1177/2150131912442388. Epub 2012 Apr 4.

Reference Type BACKGROUND
PMID: 23804172 (View on PubMed)

Patterson L, Morzinski J, Ertl K, Wurm C, Hayes A, Whittle J. Engaging community-based veterans' organizations in health promotion programs. Fam Community Health. 2011 Oct-Dec;34(4):311-8. doi: 10.1097/FCH.0b013e31822b5425.

Reference Type BACKGROUND
PMID: 21881418 (View on PubMed)

Whittle J, Fletcher KE, Morzinski J, Ertl K, Patterson L, Jensen W, Schapira MM. Ethical challenges in a randomized controlled trial of peer education among veterans service organizations. J Empir Res Hum Res Ethics. 2010 Dec;5(4):43-51. doi: 10.1525/jer.2010.5.4.43.

Reference Type BACKGROUND
PMID: 21133786 (View on PubMed)

Shirk J, Fletcher K, Patterson L, Grippen A, Eastwood D, Whittle JC. Peer leader characteristics do not predict their ability to deliver a peer support intervention. [Abstract]. Journal of general internal medicine. 2010 Jul 1; 25(Supple 3):S347.

Reference Type BACKGROUND

Hayes A, Morzinski J, Ertl K, Wurm C, Patterson L, Wilke N, Whittle J. Preliminary description of the feasibility of using peer leaders to encourage hypertension self-management. WMJ. 2010 Apr;109(2):85-90.

Reference Type BACKGROUND
PMID: 20443327 (View on PubMed)

Whittle J, Schapira MM, Fletcher KE, Hayes A, Morzinski J, Laud P, Eastwood D, Ertl K, Patterson L, Mosack KE. A randomized trial of peer-delivered self-management support for hypertension. Am J Hypertens. 2014 Nov;27(11):1416-23. doi: 10.1093/ajh/hpu058. Epub 2014 Apr 22.

Reference Type RESULT
PMID: 24755206 (View on PubMed)

Whittle JC, Hayes A, Eastwood D, Morzinski J, Ertl K, Wurm C. Effect on health behaviors of a health promotion intervention delivered through veterans service organizations. [Abstract]. Journal of general internal medicine. 2010 Jul 1; 25(Supple 3):S264.

Reference Type RESULT

Related Links

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http://www.milwaukee.va.gov/Power/Power.asp

Click here for more information about this study: Working with Veterans Organizations to Improve Blood Pressure

Other Identifiers

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IAB 06-086

Identifier Type: -

Identifier Source: org_study_id

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