Clinical trial NCT00571038: Working With Veterans Organizations to Improve Blood Pressure
Official title: Working With Veterans Organizations to Improve Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Self-help groups
Community health networks
Health knowledge, attitudes, practice
Patient participation
Randomized clinical trial
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Medical College of Wisconsin
name: Veterans of Foreign Wars USA
name: Vietnam Veterans of America
name: National Association of Black Veterans
name: Korea Veterans of America, Inc.
name: Disabled American Veterans
name: AmVETS
name: Jewish War Veterans of the United States of America
name: The American Legion Department of Wisconsin
name: Wisconsin Elks Association (a branch of The Benevolent and Protective order of Elks of the United States of America)
First posted: 2007-12-11
Enrollment: 404
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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 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).

Primary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
Secondary outcomes:
measure: Change in Diastolic Blood Pressure
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Weight
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in BMI
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Health Status
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Time Since Last Physician Visit
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Non-Clinic Blood Pressure Checks
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Number of Blood Pressure Medications
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Hypertension Knowledge
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Hypertension Attitudes
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Satisfaction With Blood Pressure Treatment
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Alcohol Use
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Sodium Intake
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Physical Activity Level
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Daily Steps
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Fruit and Vegetable Intake
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Medication Adherence
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Self Efficacy
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Social Support
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Health Opinions
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
measure: Change in Patient Activation
timeFrame: 9/16/2008-8/9/2010; baseline and 12 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Clement J. Zablocki VA Medical Center, Milwaukee, WI
state: Wisconsin
Study officials:
affiliation: Clement J. Zablocki VA Medical Center, Milwaukee, WI
name: Jeffrey C Whittle, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.