What this study is
This study is a hybrid type 2 design to evaluate the effectiveness and implementation of a community-clinical linkage intervention in primary clinics to address unmet social needs for patients with diabetes living in rural communities. The study will take place in two rural communities in Kentucky, one in eastern Kentucky and one in western Kentucky.
What's being tested
- Community-Clinical Intervention
Intervention · BEHAVIORAL
The intervention involves enhancing usual care for screening patients with diabetes for unmet social needs and referring those who screen positive to a Community Health Worker. Patients who screen positive for unmet social needs will work with CHWs to be connected to community organizations.
Study details
- Official title
- Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes Living in Rural Settings
- Sponsor
- Mary Lacy
- Conditions
- Diabetes · Diabetes Mellitus
- Enrolling
- 12,000 people
- Starts
- 2026-03-10
- Est. completion
- 2027-10
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedClinic/Staff
You may qualify if
- Staff at the intervention or comparison clinic
You can't join if
- Staff not at the intervention or comparison clinic
Participant
You may qualify if
- Age 18 or older,
- Is a patient at the intervention or comparison clinic
- Diagnosed with diabetes
You can't join if
- Being under the age of 18,
- Not a patient at the intervention or comparison clinic
- Not diagnosed with diabetes
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Kentucky
Lexington, Kentucky, United States
- Mary E Lacy, PhD · Contact8595621126mary.lacy@uky.edu
Recruiting
Study team
Sponsor
Mary Lacy
Study ID 100380
Principal investigator
Beth Lacy Leigh
University of Kentucky
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.