Veterans Service Organizations and My HealtheVet (MHV)

This study has been completed.
Sponsor:
Collaborator:
The American Legion, Department of Wisconsin
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01597843
First received: May 10, 2012
Last updated: September 12, 2014
Last verified: September 2014
Results First Received: September 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Conditions: Hypertension
Hyperlipidemia
Coronary Artery Disease
Diabetes Mellitus
Intervention: Other: Education

  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 recruited 12 posts at the outset of the study, with the help of the Legion's state leadership. We invited all post members to complete surveys at times 0, 5 months and 10 months. The surveys were distributed by post leadership at a post meeting. We did not obtain informed consent; we obtained no personal identifiers but we obtained post.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Education in First Round Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were 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. The participants at these 4 posts received the intervention in study months 1-5. They completed survey round 1 before receiving the intervention and survey rounds 2 and 3 after receiving the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
Control First Round; Education in Second Round Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were 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. The participants at these 4 posts received the intervention in study months 6-9. They completed survey rounds 1 and 2 before receiving the intervention and survey round 3 after they received the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
Control First Round; Control Second Round; Intervention Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were 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. The participants at these 4 posts received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.

Participant Flow:   Overall Study
    Education in First Round     Control First Round; Education in Second Round     Control First Round; Control Second Round; Intervention  
STARTED     79     122     81  
Survey 1 Responses     45     71     59  
Survey 2 Responses     52     42     58  
Survey 3 Responses     65     56     76  
COMPLETED     79     122     81  
NOT COMPLETED     0     0     0  



  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.
We included the mean number of post members across the three data collection times as our best measure of participants

Reporting Groups
  Description
First Educational Intervention Group

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.

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.

Second Intervention Group

The group that receives the intervention second. The intervention is the same as for the first group.

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.

Education After Data Collection Complete This group received a similar intervention, but after all quantitative data collection complete.
Total Total of all reporting groups

Baseline Measures
    First Educational Intervention Group     Second Intervention Group     Education After Data Collection Complete     Total  
Number of Participants  
[units: participants]
  79     122     81     282  
Age [1]
[units: Years]
Mean ± Standard Deviation
  69.9  ± 10.3     65.0  ± 10.7     66.6  ± 12.4     67.1  ± 11.4  
Gender [2]
[units: Participants]
       
Female     0     0     0     0  
Male     79     122     81     282  
Proportion at Educational level [3]
[units: Proportion¬†of¬†participants]
Mean ± Standard Deviation
       
Less than high school     0.068  ± 0.25     0.030  ± 0.17     0.057  ± 0.23     0.052  ± 0.22  
High school or GED     0.617  ± 0.48     0.438  ± 0.50     0.674  ± 0.469     0.580  ± 0.494  
College or technical degree     0.241  ± 0.428     0.479  ± 0.500     0.233  ± 0.423     0.315  ± 0.465  
Missing     0.074  ± 0.262     0.053  ± 0.224     0.036  ± 0.186     0.053  ± 0.224  
[1] Age from self reported survey. We combined data from all three survey rounds to obtain the most stable estimate of age. Note that we do not have data on all people in intervention groups, just the respondents. The mean age presented is at the person level. Thus, for each group, data from all survey respondents in the 4 posts in that group are included.
[2] Since the vast majority (> 95%)of members are male, we did not gather gender data. We report them as 100% male, knowing this is likely incorrect.
[3] Self report on survey. The mean presented is the mean proportion of all survey responses from each of the posts in each group. We treated all surveys as independent. Thus, the proportion of responses in each category (i.e., Less than high school; High school or GED; college or technical degree; Missing) adds up to 1.0 for each group.



  Outcome Measures

1.  Primary:   Registration for MHV   [ Time Frame: Baseline; After Group 1 Intervention; After Group 2 Intervention ]


  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
Response rates on surveys were lower than expected. One of the first round intervention posts almost certainly did not deliver anything resembling the planned educational intervention at any point.


  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


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01597843     History of Changes
Other Study ID Numbers: RRP 11-408
Study First Received: May 10, 2012
Results First Received: September 8, 2014
Last Updated: September 12, 2014
Health Authority: United States: Federal Government