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NCT02407132 · ClinicalTrials.gov registry record · NA
Family Model of Diabetes Self-Management Education in the Marshallese Community
A NA study, sponsored by University of Arkansas.
- Completed
- Registry status
- NA
- Development phase
- 221
- Enrollment target
NCT02407132: Completed NA study, sponsored by University of Arkansas.
NCT02407132 is a NA study that has completed, run by University of Arkansas. The registered enrollment target is 221 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02407132, a NA study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- NA
- Development phase
- 221 participants
- Enrollment target
Study Summary
The investigators will conduct a comparative effectiveness evaluation using a randomized control trial design of a culturally adapted family model of Diabetes Self-Management Education (Adapted DSME) compared with Standard DSME within the Marshallese population. The family model will cover the same concepts as the standard format. However, the family model will incorporate culturally-adapted education and recommendations aimed at engaging family members in the management of the primary participant's diabetes, and family members will be invited to fully participate in the study. By contrast, the standard model provides diabetes self- management education to the diabetic participant only, and the participant's family members do not participate in the classes or any other part of the study. Biometric and survey data will be collected pre-intervention, post-intervention, 6 months post-intervention, and 12 months post-intervention. A qualitative debriefing session will be held for each family between the final DSME session and the 6 month post-intervention to obtain qualitative data regarding the participant's perceptions of the intervention and implementation process.
Primary Outcome
A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant. The primary outcome measure was change in adjusted mean HbA1c (%) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. Analyses were adjusted for baseline sex, age, education, marital status, employment status, use of diabetes medication, and households containing multiple participants. The mean HbA1c values presented here have been adjusted, where
Interventions
- BEHAVIORAL Adapted DSME
- BEHAVIORAL Standard DSME
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2015-06 |
| Est. Completion | 2018-04-30 |
| Phase | NA |
What the finished NCT02407132 record still lists
NCT02407132 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Adapted DSME is the first listed.
NCT02407132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02407132 about?
NCT02407132 is a clinical study titled "Family Model of Diabetes Self-Management Education in the Marshallese Community". The investigators will conduct a comparative effectiveness evaluation using a randomized control trial design of a culturally adapted family model of Diabetes Self-Management Education (Adapted DSME) compared with Standard DSME within the Marshallese population. The family model will cover the same ...
What is the current status of trial NCT02407132?
This trial is currently completed. It is a NA study. The enrollment target is 221 participants. The study started on 2015-06. Estimated completion is 2018-04-30.
What interventions are being tested in trial NCT02407132?
The interventions under investigation include: Adapted DSME (BEHAVIORAL), Standard DSME (BEHAVIORAL).
Who is sponsoring clinical trial NCT02407132?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02407132's enrollment target sits among peer trials
221 481st of 2000 higher than 1,520 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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