Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: December 1, 2014
Last verified: December 2014
Results First Received: October 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Hypertension
Interventions: Behavioral: Peer Led
Behavioral: Seminar

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We wrote letters to posts located within 60 miles of the study hospital and followed up with a phone call to arrange for an in-person presentation. Before and after the presentation, we measured blood pressures and asked about diagnoses of hypertension. We scheduled individual appointments with potential subjects to confirm eligibility and consent.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Posts had to identify two potential peer leaders to be eligible for the trial. The post membership voted on whether to participate, even though many would not be followed as study members. All enrollment activities occurred before posts were assigned to an intervention. All participants within a post received the assigned intervention.

Reporting Groups
  Description
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.
Seminar Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.

Participant Flow:   Overall Study
    Peer Led     Seminar  
STARTED     219     185  
6 Month Follow up     208     176  
18 Month Survey Only     199     163  
COMPLETED     208 [1]   171 [2]
NOT COMPLETED     11     14  
Lost to Follow-up                 1                 4  
Death                 7                 5  
Withdrawal by Subject                 1                 3  
Moved out of state                 2                 2  
[1]

7 died 2 moved

1 asked to be withdrawn

1 unable to reach

[2] 5 died 2 moved 3 asked to be withdrawn 4 unable to reach



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Seminar Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
Total Total of all reporting groups

Baseline Measures
    Peer Led     Seminar     Total  
Number of Participants  
[units: participants]
  219     185     404  
Age  
[units: years]
Mean ± Standard Deviation
  68.8  ± 9.97     67.4  ± 10.3     68.2  ± 10.1  
Gender  
[units: participants]
     
Female     34     17     51  
Male     185     168     353  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     2     1     3  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     3     8     11  
White     214     175     389  
More than one race     0     1     1  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     219     185     404  



  Outcome Measures
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1.  Primary:   Change in Systolic Blood Pressure   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

2.  Secondary:   Change in Diastolic Blood Pressure   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

3.  Secondary:   Change in Weight   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

4.  Secondary:   Change in BMI   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

5.  Secondary:   Change in Health Status   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

6.  Secondary:   Change in Time Since Last Physician Visit   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

7.  Secondary:   Non-Clinic Blood Pressure Checks   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

8.  Secondary:   Change in Number of Blood Pressure Medications   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

9.  Secondary:   Change in Hypertension Knowledge   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

10.  Secondary:   Change in Hypertension Attitudes   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

11.  Secondary:   Change in Satisfaction With Blood Pressure Treatment   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

12.  Secondary:   Change in Alcohol Use   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

13.  Secondary:   Change in Sodium Intake   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

14.  Secondary:   Change in Physical Activity Level   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

15.  Secondary:   Change in Daily Steps   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

16.  Secondary:   Change in Fruit and Vegetable Intake   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

17.  Secondary:   Change in Medication Adherence   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

18.  Secondary:   Change in Self Efficacy   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

19.  Secondary:   Change in Social Support   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

20.  Secondary:   Change in Health Opinions   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]

21.  Secondary:   Change in Patient Activation   [ Time Frame: 9/16/2008-8/9/2010; baseline and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jeff Whittle, MD, MPH
Organization: Clement J. Zablocki VA Medical Center
phone: 414-384-2000 ext 46444
e-mail: jeffrey.whittle@va.gov


Publications of Results:
Other 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
Results First Received: October 10, 2014
Last Updated: December 1, 2014
Health Authority: United States: Federal Government