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 (a branch of The Benevolent and Protective order of Elks of the United States of America)
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00571038
First received: December 7, 2007
Last updated: April 6, 2015
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 (BP) control, increased engagement in blood pressure lowering activities (such as exercise), and a more active stance as patients.


Condition Intervention
Hypertension
Behavioral: Peer Led
Behavioral: Seminar

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: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]
    Mean/Standard Error (SE) change in systolic blood pressure


Secondary Outcome Measures:
  • Change in Diastolic Blood Pressure [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]
    Mean/SE change in diastolic blood pressure

  • Change in Weight [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]
    Mean/SE change in weight, measured in pounds (lbs)

  • Change in BMI [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]
    Mean/SE change in Body Mass Index (BMI) (kg/m2)

  • Change in Health Status [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]

    Response to the question "How would you rate your general health status?". Response options are scored as follows.

    1. Excellent
    2. Very Good
    3. Good
    4. Fair
    5. Poor We report the change in health status from baseline to 12 months.

  • Change in Time Since Last Physician Visit [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]
    Change in mean # of months since last visit to a physician

  • Non-Clinic Blood Pressure Checks [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]
    % reporting non-clinic blood pressure (BP) checks at least once a month

  • Change in Number of Blood Pressure Medications [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]
    Change in mean # of prescription blood pressure medications

  • Change in Hypertension Knowledge [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]

    Mean/SE change in score on:

    Scale: Hypertension Evaluation of Lifestyle and Management (HELM) Construct: Knowledge of hypertension and lifestyle factors related to hypertension Minimum Score: 0 Maximum Score: 14 Interpretation of Score: Higher is better


  • Change in Hypertension Attitudes [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]

    Mean/SE change in score on:

    Scale: Not applicable; series of agree/disagree statements that we wrote Construct: Attitudes around blood pressure diagnosis, treatment (including lifestyle changes), and seriousness of the condition Minimum Score: 12 Maximum Score: 60 Interpretation of Score: Lower is better


  • Change in Satisfaction With Blood Pressure Treatment [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]

    Mean/SE change in score on:

    Scale: Modified Holmes-Ravnor Satisfaction with Decision (SWD) Construct: Satisfaction with current blood pressure treatment Minimum Score: 1 Maximum Score: 5 Interpretation of Score: Lower is better (NOTE: Original instrument's scoring is reversed; i.e., higher is better)


  • Change in Alcohol Use [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]

    Mean/SE change in score on:

    Scale: Alcohol Use Disorders Identification Test (AUDIT) Construct: Alcohol use and abuse Minimum Score: 0 Maximum Score: 12 Interpretation of Score: Lower is better


  • Change in Sodium Intake [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]

    Mean/SE change in score on:

    Scale: Hopkins Dietary Questionnaire (only the dietary salt avoidance questions) Construct: Dietary sodium intake Minimum Score: 2 Maximum Score: 12 Interpretation of Score: Higher is better


  • Change in Physical Activity Level [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]

    Mean/SE change in score on:

    Scale: International Physical Activity Questionnaire (IPAQ), Metabolic Equivalent of Task (MET) Construct: Total metabolic equivalents (a measure of energy expenditure) in the last 7 days Minimum Score: 0 Maximum Score: Not applicable; based on physical activity done Interpretation of Score: Higher is better


  • Change in Daily Steps [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]
    Mean/SE change in # of steps per day (self report)

  • Change in Fruit and Vegetable Intake [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]
    Mean/SE change in # of servings per day; questions taken from the 2009 Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire

  • Change in Medication Adherence [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]

    Mean/SE change in score on:

    Scale: Morisky Adherence; questions modified to ask specifically about blood pressure medication Construct: Adherence to prescribed medication-taking regimen Minimum Score: 0 Maximum Score: 4 Interpretation of Score: Lower is better


  • Change in Self Efficacy [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]

    Mean/SE change in score on:

    Scale: Schwarzer General Perceived Self-Efficacy Construct: Perceived self-efficacy Minimum Score: 10 Maximum Score: 40 Interpretation of Score: Higher is better


  • Change in Social Support [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]

    Mean/SE change in overall score on:

    Scale: Medical Outcomes Study (MOS) Social Support Survey Construct: Overall measure of social support, including tangible, affectionate, positive social interaction, and emotional/informational Minimum Score: 0 Maximum Score: 100 Interpretation of Score: Higher is better


  • Change in Health Opinions [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]

    Mean/SE change in overall score on:

    Scale: Krantz Health Opinion Survey Construct: Opinions about healthcare and healthcare providers Minimum Score: 0 Maximum Score: 16 Interpretation of Score: Higher is better


  • Change in Patient Activation [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ] [ Designated as safety issue: No ]

    Mean/SE change in score on:

    Scale: Hibbard Patient Activation Measure (PAM) Construct: Level of patient activation and engagement in health care Minimum Score: 0 Maximum Score: 100 Interpretation of Score: Lower is better (NOTE: Original instrument's scoring is reversed; i.e., higher is better)



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: 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.
Behavioral: 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.
Other Name: Peer led education and support
Active Comparator: Seminar
Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.
Behavioral: Seminar
Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health.
Other Name: Professional didactic education

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

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 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).
  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 VA Medical Center, Milwaukee, WI
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 (a branch of The Benevolent and Protective order of Elks of the United States of America)
Investigators
Principal Investigator: Jeffrey C Whittle, MD MPH Clement J. Zablocki VA Medical Center, Milwaukee, WI
  More Information

Additional Information:
Publications:
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.
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.

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
Results First Received: October 10, 2014
Last Updated: April 6, 2015
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

ClinicalTrials.gov processed this record on September 02, 2015