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Clinical Trials/NCT00571038
NCT00571038CompletedNot Applicable

Working With Veterans Organizations to Improve Blood Pressure

US Department of Veterans Affairs1 site in 1 country404 target enrollmentStarted: February 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
404
Locations
1
Primary Endpoint
Change in Systolic Blood Pressure

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Sex
All
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 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).

Arms & Interventions

Peer Led

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.

Intervention: Peer Led (Behavioral)

Seminar

Active Comparator

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

Intervention: Seminar (Behavioral)

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 Sodium Intake(9/16/2008-8/9/2010; baseline and 12 months)
  • 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 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)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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