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NCT04259047 · ClinicalTrials.gov registry record · Phase 2
Health Beliefs, Glycemic Control, and Preventing Cognitive Decline in African Americans with Diabetes and Mild Cognitive Impairment: a Randomized Clinical Trial
A Phase 2 study of Diabetes and Mild Cognitive Impairment, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 2
- Development phase
- 145
- Enrollment target
- 1
- Study location
NCT04259047: Completed Phase 2 study of Diabetes and Mild Cognitive Impairment, sponsored by Thomas Jefferson University.
NCT04259047 is a Phase 2 study of Diabetes and Mild Cognitive Impairment that has completed, run by Thomas Jefferson University. The registered enrollment target is 145 participants, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04259047, a Phase 2 study of Diabetes and Mild Cognitive Impairment, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 145 participants
- Enrollment target
- 1
- Study location
Study Summary
This double-masked, 2-year, single-site, phase II RCT will test the efficacy of DREAM (Diabetes Regulation for Eye Sight and Memory to prevent cognitive decline in African Americans (AAs) with amnestic multiple domain mild cognitive impairment (MCI) and poorly controlled diabetes (i.e., hemoglobin A1c \[HbA1c\] level ≥ 7.5%). Participants will be randomized to DREAM \[11 home-based treatment sessions with a community health worker (CHW), and 4 telehealth visits with a Diabetes Nurse Educator over 2 years\] or Enhanced Usual Care (EUC), which is usual care enhanced with home-based diabetes education. The primary outcome is decline in verbal memory over 2 years. Follow-up data will be collected at 6, 12, 18, and 24 months. In addition, participants will have ophthalmology assessments (at Wills) at baseline, 12 and 24 months to determine whether retinal Vessel Area Density, and/or Retinal Nerve Fiber Layer thickness mediate DREAM's treatment effect.
Primary Outcome
Scores on the Hopkins Verbal Learning Test total recall (HVLT)
Conditions Studied
Interventions
- BEHAVIORAL Enhanced Usual Care
- BEHAVIORAL Diabetes Regulation for Eyesight and Memory
Study Locations (1)
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2021-10-25 |
| Est. Completion | 2024-08-31 |
| Phase | Phase 2 |
What the finished NCT04259047 record still lists
NCT04259047 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 3,028-participant average among 338 other Diabetes trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Enhanced Usual Care is the first listed.
NCT04259047 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04259047 about?
NCT04259047 is a clinical study titled "Health Beliefs, Glycemic Control, and Preventing Cognitive Decline in African Americans with Diabetes and Mild Cognitive Impairment: a Randomized Clinical Trial". This double-masked, 2-year, single-site, phase II RCT will test the efficacy of DREAM (Diabetes Regulation for Eye Sight and Memory to prevent cognitive decline in African Americans (AAs) with amnestic multiple domain mild cognitive impairment (MCI) and poorly controlled diabetes (i.e., hemoglobin A...
What is the current status of trial NCT04259047?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 145 participants. The study started on 2021-10-25. Estimated completion is 2024-08-31.
What conditions does trial NCT04259047 study?
This clinical trial studies the following conditions: Diabetes, Mild Cognitive Impairment.
What interventions are being tested in trial NCT04259047?
The interventions under investigation include: Enhanced Usual Care (BEHAVIORAL), Diabetes Regulation for Eyesight and Memory (BEHAVIORAL).
Who is sponsoring clinical trial NCT04259047?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04259047 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04259047's enrollment target sits among peer trials
145 174th of 338 higher than 165 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes 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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