Connecting clinics and community partners to address unmet social needs for people with diabetes in rural Kentucky
Official title: Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes Living in Rural Settings
Run by University of Kentucky · NCT07196007 · Data updated 2026-11-12
This project tries a clinic–community program to help adults with diabetes in two rural Kentucky communities get services for unmet social needs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12000 (estimated) |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Status | Recruiting |
| Started | March 10, 2026 |
| Main results expected | March 2027 |
| Study ends | October 2027 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07196007 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with a diagnosis of diabetes who receive care at one of the participating primary care clinics in the two rural Kentucky communities.
✕Probably not a fit
People under 18, those not receiving care at participating clinics, or patients without unmet social needs or needs already addressed by existing services are unlikely to gain benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Clinical and community partners in eastern and western Kentucky will co-create practical strategies through rapid process improvement workshops and implement them in participating primary care clinics. The core intervention combines patient navigators, health information technology, and quality-improvement support tailored to each community-clinical linkage. Clinics will be rolled out using a parallel-group cluster design and compared on referral rates, with secondary outcomes including changes in social needs status, patient-reported quality of life, and diabetes control (A1c < 9% vs ≥ 9%). Implementation outcomes will be examined with mixed methods to understand reach, acceptance, and fidelity and to identify strategies that can be scaled to other rural settings.
Why it matters
Potential benefit: If successful, the program could increase referrals to social services, reduce unmet social needs, and improve quality of life and diabetes control for patients in rural clinics.
How similar studies have gone: Similar community-clinical linkage and social-needs navigation programs have increased referrals and service use in prior work, but effects on clinical outcomes like A1c have been mixed and rigorous trials in rural settings remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Clinic/Staff Inclusion Criteria: * staff at the intervention or comparison clinic Participant Inclusion Criteria: * age 18 or older, * is a patient at the intervention or comparison clinic * diagnosed with diabetes Clinic/Staff Exclusion Criteria: * staff not at the intervention or comparison clinic Participant Exclusion Criteria: * being under the age of 18, * not a patient at the intervention or comparison clinic * not diagnosed with diabetes
Where it's running
-
University of Kentucky
Lexington, Kentucky, United States Recruiting
Study contacts
- Principal investigator: Beth Lacy Leigh — University of Kentucky
- Study coordinator: Carol R White, MPH
- Email: crwhit3@uky.edu
- Phone: 859-562-2684
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.