NCT04210024

Brief Summary

The objective of this study is to recruit influential community members using Snowball Sampling Methods. Community members identified through social network analysis as influential and well-connected will be trained as community health workers (CHW) using the Diabetes Empowerment Education Program (DEEP). These CHW will be used in a future trial to educate other members of the community.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 3, 2024

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

4.3 years

First QC Date

December 20, 2019

Results QC Date

July 12, 2024

Last Update Submit

November 26, 2024

Conditions

Keywords

Diabetes Empowerment Education Program (DEEP)social network analysisIntegrated Behavioral Model (IBM)ruralcommunityAppalachia

Outcome Measures

Primary Outcomes (2)

  • Change in Diabetes Knowledge

    The change in participants' knowledge of Type 2 Diabetes Mellitus (T2DM) will be assessed using the Diabetes Knowledge Questionnaire (DKQ) pre- and post-training with the DEEP program. The DKQ is a 24-item survey assessing diabetes knowledge. Scores range from 0-24; higher scores indicate increased knowledge of diabetes.

    6 weeks

  • Change in Health Literacy

    Change in health literacy pre- and post-education with the DEEP program will be assessed using the Newest Vital Sign (NVS) survey tool. NVS assesses health literacy based on participant interpretation of food labels. Scores range from 0-6. Lower scores indicate a high likelihood of limited literacy while higher scores indicate adequate literacy.

    6 weeks

Study Arms (1)

Rural-Dwelling Community Members/Residents

OTHER

Rural-dwelling 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. A subset of participants (\~4) will be identified as Community Health Workers and will receive training with the Diabetes Empowerment Education Program (DEEP).

Other: Diabetes Empowerment Education Program

Interventions

Individuals identified as Community Health Workers will participate in the Diabetes Empowerment Education Program (DEEP™). 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 Community Members/Residents

Eligibility Criteria

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

You may qualify if:

  • residents of Leslie County, Kentucky
  • speak and understand English

You may not qualify if:

  • 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 (2)

UK Center for Excellence in Rural Health, Kentucky Homeplace

Hyden, Kentucky, 41749, United States

Location

Stinnett Area Community Center

Stinnett, Kentucky, 40868, United States

Location

Results Point of Contact

Title
Dr. Brittany Smalls
Organization
University of Kentucky

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

December 20, 2019

First Posted

December 24, 2019

Study Start

May 3, 2019

Primary Completion

August 10, 2023

Study Completion

August 10, 2023

Last Updated

December 3, 2024

Results First Posted

December 3, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations