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NCT04334109 · ClinicalTrials.gov registry record · NA
Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations
A NA study of Diabetes Mellitus, Type 2, sponsored by University of Arkansas.
- Completed
- Registry status
- NA
- Development phase
- 550
- Enrollment target
- 1
- Study location
NCT04334109: Completed NA study of Diabetes Mellitus, Type 2, sponsored by University of Arkansas.
NCT04334109 is a NA study of Diabetes Mellitus, Type 2 that has completed, run by University of Arkansas. The registered enrollment target is 550 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04334109, a NA study of Diabetes Mellitus, Type 2, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- NA
- Development phase
- 550 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators will conduct a fully-powered, comparative effectiveness randomized controlled trial that includes up to 600 patients with type 2 diabetes (T2D) and 600 of their family members. Patients with T2D will be randomly assigned to either the Family-DSMES arm or the Standard-DSMES arm, with 300 patients in each arm. In the Family-DSMES arm, one of each patient's family members will take part in the educational sessions (family members defined below). Baseline and follow-up data (immediate post-intervention, 6 months post-intervention, and 12 months post-intervention) will be collected from patients and family members in both study arms. In the Standard-DSMES arm, data will be collected from family members, but they will not participate in educational sessions. In both arms, the investigators will obtain a medical records release to abstract outcomes at 18 months post-intervention.
Primary Outcome
A Siemens DCA Vantage analyzer was utilized to collect HbA1c from participants via finger stick blood collection (except for 12 months post-intervention and 18 months post-intervention, which was collected through medical record abstractions).
Conditions Studied
Interventions
- BEHAVIORAL Family Diabetes Self-Management Education and Support
- BEHAVIORAL Standard Diabetes Self-Management Education and Support
Study Locations (1)
Arkansas
- University of Arkansas for Medical Sciences Northwest - Fayetteville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2021-01-04 |
| Est. Completion | 2024-09-17 |
| Phase | NA |
What the finished NCT04334109 record still lists
NCT04334109 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Family Diabetes Self-Management Education and Support is the first listed.
NCT04334109 reports a single indexed study location in Arkansas.
Frequently Asked Questions
What is clinical trial NCT04334109 about?
NCT04334109 is a clinical study titled "Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations". The investigators will conduct a fully-powered, comparative effectiveness randomized controlled trial that includes up to 600 patients with type 2 diabetes (T2D) and 600 of their family members. Patients with T2D will be randomly assigned to either the Family-DSMES arm or the Standard-DSMES arm, wit...
What is the current status of trial NCT04334109?
This trial is currently completed. It is a NA study. The enrollment target is 550 participants. The study started on 2021-01-04. Estimated completion is 2024-09-17.
What conditions does trial NCT04334109 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT04334109?
The interventions under investigation include: Family Diabetes Self-Management Education and Support (BEHAVIORAL), Standard Diabetes Self-Management Education and Support (BEHAVIORAL).
Who is sponsoring clinical trial NCT04334109?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04334109 being conducted?
This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04334109's enrollment target sits among peer trials
550 69th of 348 higher than 280 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 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.
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