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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01597843
Other study ID # RRP 11-408
Secondary ID
Status Completed
Phase N/A
First received May 10, 2012
Last updated April 6, 2015
Start date June 2012
Est. completion date January 2014

Study information

Verified date February 2014
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This project will design, deliver, and evaluate a peer support intervention that will help veterans become familiar with and register for Veterans Health Administration (VHA) My HealtheVet (MHV). It will lay the groundwork for 2 types of future projects. First, the investigators will develop materials that can be used in other settings to increase registration, authentication, and meaningful use of MHV. Second, it will allow us to develop and study interventions that use informed, peer-supported Internet use to improve health behaviors and outcomes among veterans.


Description:

BACKGROUND/RATIONALE: Despite the promise of electronic health resources, there is evidence that they have not led to the improved self management that many envisioned. There is evidence for this from a variety of sources, including the Veterans Health Administration (VHA). Although there is appropriate attention to improving the functionality and ease of use of the system, a key barrier is patient acceptance and familiarity. Peer support, particularly in group settings, can improve health-related behaviors. Such approaches may increase and improve MHV use.

OBJECTIVES: Our goal in the present project is to develop and test a peer-based mechanism to increase MHV use by member of veterans service organizations (VSO) such as the American Legion. The investigators will address 3 specific aims:

1. To demonstrate that trained members of VSO can provide basic MHV education and support within their VSO unit using mobile computers.

2. To demonstrate that this intervention increases MHV registration, in person authentication (IPA), and reported use of MHV among veteran post members.

3. To create clear, concise, and portable resources that will make it possible to replicate this process in other VSO units or other community settings.

METHODS: This implementation study is a quasi-randomized intervention with delayed controls. Working with the leadership of selected veterans groups, the investigators will identify 12 posts that have the appropriate resources and interests to serve as pilot posts for the present project. The investigators will train 2 peer mentors (super-users or SU) from 4 of these posts using adaptations of the peer training approach the investigators used for a previous project. The investigators will work with the SU to install computers with wireless broadband Internet access at their posts. The investigators will load the computers with software that documents unique sessions, sites visited, and amount of time at each site. The investigators will help the SU provide lessons regarding MHV use to his/her fellow post members at 4 monthly post meetings. After 4 months, the investigators will move the computers to the next 4 posts and repeat the intervention. Finally, the investigators will move the computers to the last 4 posts, providing remote support and our training materials to the SU at those posts. The investigators will use computer tracking data, surveys, focus groups, and interviews to assess the impact of the program. The investigators will test changes in registration, IPA, and use with before and after surveys. Our analysis will adjust for clustering within posts. The investigators will transcribe our focus groups and interviews verbatim and analyze them using a case study approach.


Recruitment information / eligibility

Status Completed
Enrollment 282
Est. completion date January 2014
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Two steps, first a post is enrolled, then a member participates.

Post eligible if:

- The post leadership agrees that the post will support participation.

- Two or more members of the post agree to serve as MHV super-users.

- There is an identifiable location within the post for the computer.

Member eligible if:

- Member of post

- Attends the meeting at which the survey is administered

Exclusion Criteria:

- Does not consent to survey

- Does not attend meeting where survey administered

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Intervention

Other:
Education
Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV.

Locations

Country Name City State
United States Clement J. Zablocki VA Medical Center, Milwaukee, WI Milwaukee Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
VA Office of Research and Development The American Legion Department of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Registration for MHV Measured by response to question: Have you ever used My HealtheVet online? Baseline; After Group 1 Intervention; After Group 2 Intervention No
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