Mode
Text Size
Log in / Sign up
N/A N=701 Randomized Treatment

Clinic to Community Navigation to Improve Diabetes Outcomes

Diabetes Mellitus

Enrolled (actual)
701
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Change in Hemoglobin A1c — -0.37; -0.15; -0.31; -0.20 percentage of glycated hemoglobin

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
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)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Nancy Schoenberg
Primary completion
Jul 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Hemoglobin A1c
-0.37; -0.15; -0.31; -0.20; -0.38; -0.37
SECONDARY
Change in Body Mass Index
-0.06; -0.23; -0.44; -0.14; -0.05; -0.34
SECONDARY
Change in Waist Circumference
-0.25; -0.41; -0.54; -0.46; -0.63; -0.89
SECONDARY
Number of Participants Attending a Clinic Visit
113; 118; 70; 87; 15; 22
SECONDARY
Change in Systolic Blood Pressure
-4.37; -0.47; -2.97; -3.86; -4.22; 0.46
SECONDARY
Change in Diastolic Blood Pressure
-2.25; -1.60; -3.01; -1.12; -1.79; -1.69
SECONDARY
High Density Lipoprotein (HDL)
SECONDARY
Low Density Lipoprotein (LDL)
SECONDARY
Total Cholesterol
SECONDARY
Change in Physical Component Summary Score of SF-36
0.29; -0.74; -1.39; 1.00; 1.00; -0.40
SECONDARY
Change in Mental Component Summary Score of SF-36
1.67; 1.73; 4.24; 1.21; 1.56; 1.66

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.

Eligibility Criteria

Inclusion Criteria

  • Adults (age 18+);
  • Appalachian residence, no plans to relocate out of the area in the next 18 months,
  • Willingness and ability to participate (i.e., no major cognitive impairment)
  • HbA1c levels at least 6.5% or Diagnosis of Diabetes.

Exclusion Criteria

-

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03474731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search