NCT04568486

Brief Summary

This study seeks to describe and evaluate the impact of social support on self-care and clinical outcomes in rural-dwelling older adults with T2DM, test the feasibility and preliminary effectiveness of a 6-week intervention administered by community health workers targeting rural dwelling older adults with T2DM (seed) and an individual within their social support network (alter).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 13, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

3.2 years

First QC Date

September 16, 2020

Results QC Date

November 26, 2024

Last Update Submit

February 12, 2025

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    The change in participants' hemoglobin A1c measures will be abstracted from their medical records pre- and post-training with the DEEP program. Improved hemoglobin A1c figures suggest an overall success of the DEEP program and a better ability for patients to manage their diabetes.

    12 months

Secondary Outcomes (6)

  • Systolic Blood Pressure

    12 months

  • Diastolic Blood Pressure

    12 months

  • Lipids

    6 weeks

  • Self-care

    12 months

  • Medication Adherence

    12 months

  • +1 more secondary outcomes

Study Arms (1)

Rural-dwelling older adults (seed) and Key players (alter

OTHER

Rural-dwelling older adults will be interviewed to map their social network structure, determine the types of social support provided by members of their social network, and identify key players within these networks. This group will be paired with their key players (identified during interviews) to receive the diabetes education. The pair complete the intervention as a dyad.

Other: Diabetes Empowerment Education Program

Interventions

Diabetes Empowerment Education ProgramOTHER

The Diabetes Empowerment Education Program (DEEP) is an education curriculum designed to help people with pre-diabetes, diabetes, relatives and caregivers gain a better understanding of diabetes self-care. Classes last a total of six weeks, providing participants with eight unique learning modules. Health literacy will be assessed before and after participating in DEEP.

Rural-dwelling older adults (seed) and Key players (alter

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed diagnosis of T2DM via electronic medical record
  • age 65 years or older
  • lives within Leslie County
  • able to provide consent
  • have had at least one clinic visit in the past year

You may not qualify if:

  • no diagnosis of T2DM via electronic medical record
  • under 65 years of age
  • unable to speak and understand English
  • unable to consent
  • years of age or older
  • able to provide consent
  • has at least weekly contact with the seed
  • under 18 years of age
  • unable to speak and understand English
  • unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UK Center for Excellence in Rural Health, Kentucky Homeplace

Hyden, Kentucky, 41749, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Brittany Smalls
Organization
University of Kentucky
brittany.smalls@uky.edu
859-323-4916

Study Officials

  • Brittany Smalls, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 29, 2020

Study Start

October 1, 2020

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

February 13, 2025

Results First Posted

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)