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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 is a Phase 3 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 156 participants.

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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.

Interventions

  • BEHAVIORAL PREVENT
  • BEHAVIORAL EUC (Enhanced Usual Care)

Trial Details

FieldValue
Enrollment Target 156 participants
Start Date 2019-01-10
Est. Completion 2023-09-30
Phase Phase 3

Sponsor

Thomas Jefferson University

292 total trials

What the Registry Record Tells You About NCT03466866

The ClinicalTrials.gov registry entry for NCT03466866 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which PREVENT is the first listed.

NCT03466866 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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