Clinic to Community Navigation to Improve Diabetes Outcomes

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.

Conditions

• Diabetes Mellitus

Interventions

BEHAVIORAL

Diabetes Self-Management Program (DSMP)

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.

BEHAVIORAL

Tailored Patient Navigation (PN) only

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.

BEHAVIORAL

DSMP AND Tailored Patient Navigation

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

BEHAVIORAL

Diabetes Self-Management Program (DSMP) Delayed

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Nancy Schoenberg

  lead OTHER

Principal Investigators

• Nancy Schoenberg, PhD · University of Kentucky

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-29

Primary Completion

2023-07-10

Completion

2023-07-10

Countries

• United States

Study Locations