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NCT03466866 · ClinicalTrials.gov registry record · Phase 3
Reducing Emergency Diabetes Care for Older African Americans
A Phase 3 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 3
- Development phase
- 156
- Enrollment target
NCT03466866: Completed Phase 3 study, sponsored by Thomas Jefferson University.
NCT03466866 is a Phase 3 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 156 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03466866, a Phase 3 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 156 participants
- Enrollment target
Study Summary
This RCT will compare the efficacy of Preventing and Reducing Emergency Visits in Diabetes through Education and Trust (PREVENT) vs. intensive home-based diabetes (DM) education \[i.e., Enhanced Usual Care (EUC)\] to reduce DM-related emergency department (ED) visits and/or hospitalizations over 12 months (primary outcome) in 230 blacks with diabetes, 50 years and older, after an ED visit. A moderation analysis will determine whether participants who reside in low- vs. high-need communities \[defined by Community Need Index scores (i.e., an indicator of the built environment)\] respond differently to treatment. PREVENT is a collaborative intervention of Primary Care Physicians, (PCPs), a DM nurse educator, and Community Health Workers (CHWs) that extends from the ED into the community. The CHWs will: 1) deliver in-home DM education to increase participants' knowledge and skills to manage DM; 2) use DM-specific Behavioral Activation to reinforce DM self-care; and 3) facilitate telehealth visits with PCPs and a DM nurse educator to increase access to care. The control treatment, EUC, is home-based intensive DM education. EUC matches PREVENT in treatment intensity (i.e., number and duration of in-home visits) and delivery of DM self-care education, but does not include PREVENTS's other active elements (i.e., Behavioral Activation and telehealth). The treatment comparison will identify PREVENTS's specific efficacy over and above EUC. We hypothesize that PREVENT will halve the rate of incident DM-related ED visits and/or hospitalizations relative to EUC. The three secondary outcomes are: 1) subjective perceptions of access to care; 2) receipt of DM Quality Metrics (i.e., objective indicators of realized access to care); and 3) DM self-care.
Primary Outcome
The primary efficacy analysis will consider the number of incident diabetes-related ED visits and/or hospitalizations (i.e., an "event") over 12 months after the index ED visit. Each ED visit or hospitalization is counted as a single event (although an ED visit that leads to a hospitalization is counted once). ED visits and hospitalization will be ascertained through chart reviews and subject self-report.
Interventions
- BEHAVIORAL PREVENT
- BEHAVIORAL EUC (Enhanced Usual Care)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2019-01-10 |
| Est. Completion | 2023-09-30 |
| Phase | Phase 3 |
What the finished NCT03466866 record still lists
NCT03466866 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which PREVENT is the first listed.
NCT03466866 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03466866 about?
NCT03466866 is a clinical study titled "Reducing Emergency Diabetes Care for Older African Americans". This RCT will compare the efficacy of Preventing and Reducing Emergency Visits in Diabetes through Education and Trust (PREVENT) vs. intensive home-based diabetes (DM) education \[i.e., Enhanced Usual Care (EUC)\] to reduce DM-related emergency department (ED) visits and/or hospitalizations over 12 ...
What is the current status of trial NCT03466866?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 156 participants. The study started on 2019-01-10. Estimated completion is 2023-09-30.
What interventions are being tested in trial NCT03466866?
The interventions under investigation include: PREVENT (BEHAVIORAL), EUC (Enhanced Usual Care) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03466866?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03466866's enrollment target sits among peer trials
156 1506th of 2000 higher than 492 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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