Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Nancy Schoenberg.
NCT03474731 is a NA study that has completed, run by Nancy Schoenberg. The registered enrollment target is 701 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Changes in hemoglobin A1c (HbA1c) will be measured with a Bayer DCA 2000+ Analyzer (21), which has a test coefficient of variation \< 5% consistent with requirements of the National Diabetes Data Group.
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
| Field | Value |
|---|---|
| Enrollment Target | 701 participants |
| Start Date | 2018-04-29 |
| Est. Completion | 2023-07-10 |
| Phase | NA |
What the finished NCT03474731 record still lists
NCT03474731 is an interventional study that assigns participants to a tested intervention. The registered 701 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 4 interventions - of which Diabetes Self-Management Program (DSMP) is the first listed.
NCT03474731 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03474731's enrollment target sits among peer trials
701 149th of 2000 higher than 1,852 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06027996 · 702 participants · NA
Melodi Matrix™ in Breast Reconstruction
- NCT00900419 · 700 participants
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
- NCT01804686 · 700 participants · Phase 3
A Long-term Extension Study of PCI-32765 (Ibrutinib)
- NCT02107989 · 700 participants
Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI