CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 701 enrolled
Drug / intervention
Diabetes Self-Management Program (DSMP) +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03474731
NCT03474731N/ACompleted

Clinic to Community Navigation to Improve Diabetes Outcomes

Nancy Schoenberg·interventional·Posted Mar 23, 2018·Updated Aug 29, 2024

In Brief

A clinical study evaluating Diabetes Self-Management Program (DSMP), Tailored Patient Navigation (PN) only, and 2 other interventions for Diabetes Mellitus. Completed, enrolled 701 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 23, 2018
Enrollment StartApr 29, 2018
Primary CompletionJul 10, 2023
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 8.3 years ago

Interventions

Diabetes Self-Management Program (DSMP)behavioral

The the Diabetes Self Management Program (DSMP) in a group setting: participants will attend a six week, evidence-based diabetes home self-management program. The goal of this arm of the project is to try to get participants to engage in better diabetes self-care (blood glucose testing, medication taking, diet, exercise, stress reduction, etc.). Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.

Tailored Patient Navigation (PN) onlybehavioral

Tailored Patient Navigation (PN) only: trained Community Health Workers (CHW) will meet one-on-one with participants to assess the barriers experienced in adhering to medical appointments and will implement a navigation program accordingly. The goal of this arm of the project is to try to get participants to attend recommended medical appointments. PN has been shown to improve health behavior and increase self-efficacy, all with low costs.

DSMP AND Tailored Patient Navigationbehavioral

DSMP AND Tailored Patient Navigation : patient navigation followed by 6 weeks of DSMP classes after the 3 month post-test interview.

Diabetes Self-Management Program (DSMP) Delayedbehavioral

Groups randomized to DSMP Delayed will receive 6 weeks of DSMP classes after the 3 month post-test interview. Participants will complete biometric data and surveys at 3, 6, and 9 months post randomization.