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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04334109
The ClinicalTrials.gov registry entry for NCT04334109 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 550 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (88% lower). The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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