Connecting clinics and community partners to address unmet social needs for people with diabetes in rural Kentucky
Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes Living in Rural Settings
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT07196007 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lexington, Kentucky
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.