NCT00571038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4 years until next milestone

Results Posted

Study results publicly available

December 11, 2014

Completed
Last Updated

April 24, 2015

Status Verified

August 1, 2014

Enrollment Period

2.5 years

First QC Date

December 7, 2007

Results QC Date

October 10, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

HypertensionSelf-help groupsCommunity health networksHealth knowledge, attitudes, practicePatient participationRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Change in Systolic Blood Pressure

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

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

Secondary Outcomes (20)

  • Change in Diastolic Blood Pressure

    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 BMI

    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

  • +15 more secondary outcomes

Study Arms (2)

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.

Behavioral: Peer Led

Seminar

ACTIVE COMPARATOR

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

Behavioral: Seminar

Interventions

Peer LedBEHAVIORAL

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.

Also known as: Peer led education and support
Peer Led
SeminarBEHAVIORAL

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

Also known as: Professional didactic education
Seminar

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, 53295-1000, United States

Location

Related Publications (7)

  • 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.

    PMID: 23804172BACKGROUND
  • 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.

    PMID: 21881418BACKGROUND
  • 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.

    PMID: 21133786BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 20443327BACKGROUND
  • 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.

  • 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.

    RESULT

Related Links

MeSH Terms

Conditions

HypertensionBehaviorPatient Participation

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Jeff Whittle, MD, MPH
Organization
Clement J. Zablocki VA Medical Center

Study Officials

  • Jeffrey C Whittle, MD MPH

    Clement J. Zablocki VA Medical Center, Milwaukee, WI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2007

First Posted

December 11, 2007

Study Start

February 1, 2008

Primary Completion

August 1, 2010

Study Completion

December 1, 2010

Last Updated

April 24, 2015

Results First Posted

December 11, 2014

Record last verified: 2014-08

Locations