Working With Veterans Organizations to Improve Blood Pressure (POWER)

This study has been completed.
Sponsor:
Collaborators:
Medical College of Wisconsin
Veterans of Foreign Wars
Vietnam Veterans of America
National Association of Black Veterans
Korean War Veterans of America
Disabled American Veterans
AmVETS
Jewish War Veterans of the U.S.A.
American Legion Department of Wisconsin
Wisconsin Elks Association
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00571038
First received: December 7, 2007
Last updated: August 5, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in systolic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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 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.
  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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571038

Locations
United States, Wisconsin
Clement J. Zablocki VAMC
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
Medical College of Wisconsin
Veterans of Foreign Wars
Vietnam Veterans of America
National Association of Black Veterans
Korean War Veterans of America
Disabled American Veterans
AmVETS
Jewish War Veterans of the U.S.A.
American Legion Department of Wisconsin
Wisconsin Elks Association
Investigators
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: August 5, 2014
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 October 01, 2014