HypertensionNCT01597843
Veterans Service Organizations and My HealtheVet (MHV)
A study testing Education in people with Hypertension and Hyperlipidemia, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Hyperlipidemia, Coronary Artery Disease
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not consent to survey
- Does not attend meeting where survey administered
Trial locations and contacts
1 site in 1 country.
United States1 site
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-1000
About this study
Official title: Working With Veterans Organizations to Encourage Use of My HealtheVet
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.
Read the detailed 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:
- To demonstrate that trained members of VSO can provide basic MHV education and support within their VSO unit using mobile computers.
- To demonstrate that this intervention increases MHV registration, in person authentication (IPA), and reported use of MHV among veteran post members.
- 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.
- Being tested
- Education
- Keywords
- education, self care, peer group, Computers, Attitude to computers
- Medical subject headings
- Hypertension, Hyperlipidemias, Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Also called Post 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.
| Study group | Role | What they receive |
|---|---|---|
| First educational intervention group | Experimental | Group that receives intervention first. The intervention is a 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. Receives: Other: Education |
| Second intervention group | Experimental | This arm receives a series of training sessions over study months 6-9. The training sessions are in person and on line and are directed at post superusers who will in turn educate post members on the utility and mechanics of use of MHV. They complete survey rounds 1 and 2 before the training and survey round 3 after the training. Receives: Other: Education |
| Education after data collection complete | No intervention | This group received a similar intervention, but after all quantitative data collection complete. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Registration for MHV
Measured by response to question: Have you ever used My HealtheVet online?
Measured: Baseline; After Group 1 Intervention; After Group 2 Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- The American Legion Department of Wisconsin
- Responsible party
- Sponsor
- Investigators
- Jeffrey C Whittle, MD MPH, Principal investigator, Clement J. Zablocki VA Medical Center, Milwaukee, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597843
- Sponsor's protocol ID
- RRP 11-408
- Status last verified
- Feb 2014
- First submitted
- 10 May 2012
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Working With Veterans Organizations to Encourage Use of My HealtheVet
- ClinicalTrials.gov ID
- NCT01597843
- Acronym / sponsor ID
- RRP 11-408
- Keywords
- education, self care, peer group, Computers, Attitude to computers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- The American Legion Department of Wisconsin
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 May 2012 (estimated)
- Results
- Posted 12 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- To demonstrate that trained members of VSO can provide basic MHV education and support within their VSO unit using mobile computers.
- To demonstrate that this intervention increases MHV registration, in person authentication (IPA), and reported use of MHV among veteran post members.
- 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First educational intervention group | Experimental | Other: EducationGroup that receives intervention first. The intervention is a 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. |
| Second intervention group | Experimental | Other: EducationThis arm receives a series of training sessions over study months 6-9. The training sessions are in person and on line and are directed at post superusers who will in turn educate post members on the utility and mechanics of use of MHV. They complete survey rounds 1 and 2 before the training and survey round 3 after the training. |
| Education after data collection complete | No intervention | –This group received a similar intervention, but after all quantitative data collection complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Two steps, first a post is enrolled, then a member participates.
- 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 of post
Key exclusion criteria (2 listed)
- Does not consent to survey
- Does not attend meeting where survey administered
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationAlso: Post educationSeries 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. | Other | First educational intervention group, Second intervention group |
Primary outcome
Registration for MHV
Time frame: Baseline; After Group 1 Intervention; After Group 2 Intervention
Measured by response to question: Have you ever used My HealtheVet online?
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- American Legion Website for Department of WisconsinLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey C Whittle, MD MPH principal investigator
Clement J. Zablocki VA Medical Center, Milwaukee, WI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Hypertension and Hyperlipidemia, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registration for MHV (time frame: Baseline; After Group 1 Intervention; After Group 2 Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.