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NCT03474731 · ClinicalTrials.gov registry record · NA

Clinic to Community Navigation to Improve Diabetes Outcomes

A NA study, sponsored by Nancy Schoenberg.

Completed
Registry status
NA
Development phase
701
Enrollment target

NCT03474731 is a NA study that has completed, run by Nancy Schoenberg. The registered enrollment target is 701 participants.

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The verdict

NCT03474731, a NA study, has completed, sponsored by Nancy Schoenberg.

COMPLETED
Registry status
NA
Development phase
701 participants
Enrollment target

Study Summary

Background and justification: Nearly 29 million Americans (9.3% of the population) have type 2 Diabetes Mellitus (T2DM) and another 86 million are considered prediabetic, 20-30% of whom will develop diabetes within five years.4,5 T2DM disproportionately affects those from lower socioeconomic status (SES) and rural backgrounds. Appalachian residents represent an extreme version of this already vulnerable population, with rates of diabetes 46% higher than national averages.6,7 The investigators have developed, pilot tested (N=41) and refined (N=48 in-depth interviews, 4 focus groups with 31 participants, and 2 CAB meetings with 16 members), a culturally appropriate, feasible, and promising intervention that combines diabetes self-management education and tailored patient navigation intervention., Goal: Our goal focuses on reducing HbA1c, BMI, blood pressure, lipids, and waist circumference and improving T2DM self-management and clinic attendance. Leveraging local assets, including faith communities, local health facilities, trained community health workers, and social support, the investigators will expand a promising and refined pilot study and assess outcomes, satisfaction and cost effectiveness. Innovation and impact: The proposed project is among the first RCT to combine the two most influential approaches to diabetes control-- self-management education and tailored patient navigation in a community setting. The Community to Clinic Navigation (CCN) intervention has the potential to sustainably empower hard to reach populations with effective self-management education and enhance the quality of healthcare in traditionally underserved communities, greatly improving T2DM outcomes.

Interventions

  • BEHAVIORAL Diabetes Self-Management Program (DSMP)
  • BEHAVIORAL Tailored Patient Navigation (PN) only
  • BEHAVIORAL DSMP AND Tailored Patient Navigation
  • BEHAVIORAL Diabetes Self-Management Program (DSMP) Delayed

Trial Details

FieldValue
Enrollment Target 701 participants
Start Date 2018-04-29
Est. Completion 2023-07-10
Phase NA

Sponsor

Nancy Schoenberg

5 total trials

What the Registry Record Tells You About NCT03474731

The ClinicalTrials.gov registry entry for NCT03474731 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 701 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nancy Schoenberg, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Diabetes Self-Management Program (DSMP) is the first listed.

NCT03474731 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03474731 about?

NCT03474731 is a clinical study titled "Clinic to Community Navigation to Improve Diabetes Outcomes". Background and justification: Nearly 29 million Americans (9.3% of the population) have type 2 Diabetes Mellitus (T2DM) and another 86 million are considered prediabetic, 20-30% of whom will develop diabetes within five years.4,5 T2DM disproportionately affects those from lower socioeconomic status ...

What is the current status of trial NCT03474731?

This trial is currently completed. It is a NA study. The enrollment target is 701 participants. The study started on 2018-04-29. Estimated completion is 2023-07-10.

What interventions are being tested in trial NCT03474731?

The interventions under investigation include: Diabetes Self-Management Program (DSMP) (BEHAVIORAL), Tailored Patient Navigation (PN) only (BEHAVIORAL), DSMP AND Tailored Patient Navigation (BEHAVIORAL), Diabetes Self-Management Program (DSMP) Delayed (BEHAVIORAL).

Who is sponsoring clinical trial NCT03474731?

This trial is sponsored by Nancy Schoenberg, which has 5 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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