Skip to main content
Clinical Trials/NCT00571038
NCT00571038
Completed
Not Applicable

Working With Veterans Organizations to Improve Blood Pressure

US Department of Veterans Affairs1 site in 1 country404 target enrollmentFebruary 2008
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
US Department of Veterans Affairs
Enrollment
404
Locations
1
Primary Endpoint
Change in Systolic Blood Pressure
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
December 2010
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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 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.
  • 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).

Outcomes

Primary Outcomes

Change in Systolic Blood Pressure

Time Frame: 9/16/2008-8/9/2010; baseline and 12 months

Mean/Standard Error (SE) change in systolic blood pressure

Secondary Outcomes

  • Change in Diastolic Blood Pressure(9/16/2008-8/9/2010; baseline and 12 months)
  • Non-Clinic Blood Pressure Checks(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Number of Blood Pressure Medications(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Medication Adherence(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Self Efficacy(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Weight(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Health Status(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Time Since Last Physician Visit(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Hypertension Attitudes(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Satisfaction With Blood Pressure Treatment(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Sodium Intake(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Patient Activation(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in BMI(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Daily Steps(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Fruit and Vegetable Intake(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Health Opinions(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Hypertension Knowledge(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Alcohol Use(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Physical Activity Level(9/16/2008-8/9/2010; baseline and 12 months)
  • Change in Social Support(9/16/2008-8/9/2010; baseline and 12 months)

Study Sites (1)

Loading locations...

Similar Trials