Clinic to Community Navigation to Improve Diabetes Outcomes

NCT03474731 | Completed Results DMC

• 2 other identifiers: 14-0314-P6HR01DK112136
• Study Type: interventional
• Target: 701
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c

  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.

  Baseline, month 3, month 6, month 9

Secondary Outcomes (10)

• Change in Body Mass Index

  Baseline, month 3, month 6, month 9

• Change in Waist Circumference

  Baseline, month 3, month 6, month 9

• Number of Participants Attending a Clinic Visit

  Baseline

• Change in Systolic Blood Pressure

  Baseline, month 3, month 6, month 9

• Change in Diastolic Blood Pressure

  Baseline, month 3, month 6, month 9

Study Arms (4)

Diabetes Self-Management Program (DSMP) only

EXPERIMENTAL

group education classes of the Diabetes Self-Management Program, (DSMP)

Behavioral: Diabetes Self-Management Program (DSMP)

Tailored Patient Navigation (PN) only

EXPERIMENTAL

assisting patients in navigation to physician offices, allowing for standard of care to follow.

Behavioral: Tailored Patient Navigation (PN) only

DSMP AND Tailored Patient Navigation

EXPERIMENTAL

Both group education classes and patient navigation

Behavioral: DSMP AND Tailored Patient Navigation

Diabetes Self-Management Program (DSMP) Delayed

ACTIVE COMPARATOR

group education classes of the Diabetes Self-Management Program, (DSMP)

Behavioral: Diabetes Self-Management Program (DSMP) Delayed

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.

Diabetes Self-Management Program (DSMP) only

Tailored Patient Navigation (PN) only BEHAVIORAL

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.

Tailored Patient Navigation (PN) only

DSMP AND Tailored Patient Navigation BEHAVIORAL

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

Also known as: Clinic to Community Navigation (CCN)

DSMP AND Tailored Patient Navigation

Diabetes Self-Management Program (DSMP) Delayed BEHAVIORAL

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.

Diabetes Self-Management Program (DSMP) Delayed

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Nancy Schoenberg: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (4)

• Smalls BL, Adegboyega A, Combs E, Rutledge M, Westgate PM, Azam MT, De La Barra F, Williams LB, Schoenberg NE. The mediating/moderating role of cultural context factors on self-care practices among those living with diabetes in rural Appalachia. BMC Public Health. 2021 Oct 2;21(1):1784. doi: 10.1186/s12889-021-11777-7.

  PMID: 34600524 BACKGROUND

• Smalls BL, Lacy ME, Adegboyega A, Hieronymus L, Bacha N, Nathoo T, Westgate PM, Azam T, Westneat S, Schoenberg NE. A New Look at Barriers to Clinical Care Among Appalachian Residents Living With Diabetes. Diabetes Spectr. 2023 Winter;36(1):14-22. doi: 10.2337/ds22-0001. Epub 2022 Nov 18.

  PMID: 36818407 BACKGROUND

• Smalls BL, Azam T, Dunfee M, Westgate PM, Westneat SC, Schoenberg N. The relationship between psychosocial factors, self-care, and blood sugar in an Appalachian population. J Appalach Health. 2023 Jan 1;4(3):1-22. doi: 10.13023/jah.0403.01. eCollection 2023.

  PMID: 38026048 BACKGROUND

• Smalls BL, Adegboyega A, Combs E, Travis EW, De La Barra F, Williams LB, Schoenberg N. Evaluating the Association Between Depressive Symptoms and Glycemic Control Among Residents of Rural Appalachia. J Appalach Health. 2023 Jan 1;4(3):39-55. doi: 10.13023/jah.0403.03. eCollection 2023.

  PMID: 38026049 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Single Person

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Results Point of Contact

• Title: Dr. Nancy Schoenberg
• Organization: University of Kentucky

nesch@uky.edu

(859) 323-8175

Study Officials

• Nancy Schoenberg, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 We 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.

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: March 23, 2018
• Study Start: April 29, 2018
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: August 29, 2024
• Results First Posted: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)