DiabetesNCT07196007
Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes
A study testing Community-Clinical Intervention in people with Diabetes and Diabetes Mellitus, run by Mary Lacy at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus
- What is being tested?
- Community-Clinical Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mary Lacy Leigh, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Mary E Lacy, PhD, 8595621126, mary.lacy@uky.edu
About this study
Official title: Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes Living in Rural Settings
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.
Read the detailed description
This study will convene clinical and community partners to complete a rapid process improvement workshop (RPIW) to co-create scalable strategies to address unmet social needs and to implement the developed strategy in primary care clinics in two rural communities in Kentucky. Results from the RPIW will be used to design an implementation template with specific implementation strategies tailored to each unique community-clinical linkage (CCL). While implementation strategies will be tailored to each CCL, the overarching intervention components for all CCL include: 1) patient navigators; 2) health information technology; and 3) quality improvement support to clinical and community partners. The finalized intervention will then be rolled out across partner clinics using a parallel-group cluster design that facilitates pragmatic randomization. The effect of the intervention on referrals will be assessed by comparing referrals between intervention and control clinics. Secondary effectiveness outcomes include status of social needs (improved or not), patient-reported quality of life, and diabetes control (A1c < 9.0% controlled vs A1c =9% uncontrolled). To evaluate implementation outcomes, we will use a mixed methods approach to examine process factors that affect reach, acceptance, and fidelity of the CCL intervention. This approach allows us to examine which strategies can be replicated and scaled up for implementation in other communities.
- Conditions
- Diabetes, Diabetes Mellitus
- Being tested
- Community-Clinical Intervention
- Keywords
- Unmet social needs
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-Clinical InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Usual Screening Patients with Diabetes for Unmet Social Needs Plus a Community-Clinical Intervention | Experimental | The intervention will be developed by community-clinical partners and then implemented in primary care clinics in two rural communities in Kentucky. Intervention components include patient navigation using a Community Health Worker (CHW), health information technology (HIT) and quality improvement (QI) support to both clinical and community partners. Patients who screen positive for unmet social needs will work with CHWs to be connected to community organizations. The HIT support component includes implementing the Kentucky Health Information Exchange referral communication tool between clinics and community organizations and using the Kynect resource directory to refer patients to location-specific social services and community resources. The QI component includes identifying a quality improvement team and site champion, one-on-one calls with a QI advisor, action periods to test QI strategies, and support to validate health outcomes and social needs screening data. Receives: Behavioral: Community-Clinical Intervention |
| Usual Care | No intervention | Clinics randomized to the control arm will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants screened for social needs
Number of participants screened for social needs intervention compared to control
Measured: Baseline, month 6 and month 12
Number of referrals to community based organization by primary care clinic
Number of referrals to community based organization in intervention compared to control
Measured: Baseline, month 6 and month 12
Secondary outcomes (3)
Change in Status of social needs
Change in status of social needs, answered by a yes/no question as to accessed or not. Social needs include food insecurity, housing instability, difficulty with utilities, transportation issues, and intimate partner violence. Data will be reported as aggregate across needs.
Measured: Baseline, month 6 and month 12
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) -29
The PROMIS - 29 measures health-related quality of life across seven domains. Scores are standardized on a T-score metric, with a mean of 50 and a standard deviation of 10 in a referent population. A higher score means more of the concept being measured.
Measured: Baseline, month 6 and month 12
Percent of participants with A1c greater than or equal to 9.0%
Change in A1c level; Diabetes control (A1c < 9.0% controlled vs A1c =9% uncontrolled) via Electronic Health Record extract
Measured: Baseline, month 6 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start10 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A hybrid type 2 design to evaluate the effectiveness and implementation of a community-clinic linkage (CCL) intervention in primary care clinics and a mixed methods approach to examine process factors that affect reach, acceptance, and fidelity of the CCL intervention.
- Masking
- None (open label)
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mary Lacy
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor-investigator, Mary Lacy, University of Kentucky
- Investigators
- Beth Lacy Leigh, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196007
- Sponsor's protocol ID
- 100380
- Other IDs
- 75D30124C20318
- Status last verified
- Feb 2026
- First submitted
- 19 Sep 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes Living in Rural Settings
- ClinicalTrials.gov ID
- NCT07196007
- Acronym / sponsor ID
- 100380
- Conditions
- Diabetes, Diabetes Mellitus
- Keywords
- Unmet social needs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Mary LacyUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will convene clinical and community partners to complete a rapid process improvement workshop (RPIW) to co-create scalable strategies to address unmet social needs and to implement the developed strategy in primary care clinics in two rural communities in Kentucky. Results from the RPIW will be used to design an implementation template with specific implementation strategies tailored to each unique community-clinical linkage (CCL). While implementation strategies will be tailored to each CCL, the overarching intervention components for all CCL include: 1) patient navigators; 2) health information technology; and 3) quality improvement support to clinical and community partners. The finalized intervention will then be rolled out across partner clinics using a parallel-group cluster design that facilitates pragmatic randomization. The effect of the intervention on referrals will be assessed by comparing referrals between intervention and control clinics. Secondary effectiveness outcomes include status of social needs (improved or not), patient-reported quality of life, and diabetes control (A1c < 9.0% controlled vs A1c =9% uncontrolled). To evaluate implementation outcomes, we will use a mixed methods approach to examine process factors that affect reach, acceptance, and fidelity of the CCL intervention. This approach allows us to examine which strategies can be replicated and scaled up for implementation in other communities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A hybrid type 2 design to evaluate the effectiveness and implementation of a community-clinic linkage (CCL) intervention in primary care clinics and a mixed methods approach to examine process factors that affect reach, acceptance, and fidelity of the CCL intervention.
| Arm | Type | Receives |
|---|---|---|
| Usual Screening Patients with Diabetes for Unmet Social Needs Plus a Community-Clinical Intervention | Experimental | Behavioral: Community-Clinical InterventionThe intervention will be developed by community-clinical partners and then implemented in primary care clinics in two rural communities in Kentucky. Intervention components include patient navigation using a Community Health Worker (CHW), health information technology (HIT) and quality improvement (QI) support to both clinical and community partners. Patients who screen positive for unmet social needs will work with CHWs to be connected to community organizations. The HIT support component includes implementing the Kentucky Health Information Exchange referral communication tool between clinics and community organizations and using the Kynect resource directory to refer patients to location-specific social services and community resources. The QI component includes identifying a quality improvement team and site champion, one-on-one calls with a QI advisor, action periods to test QI strategies, and support to validate health outcomes and social needs screening data. |
| Usual Care | No intervention | –Clinics randomized to the control arm will receive usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-Clinical InterventionThe 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. | Behavioural | Usual Screening Patients with Diabetes for Unmet Social Needs Plus a Community-Clinical Intervention |
Primary outcome
Number of participants screened for social needs
Time frame: Baseline, month 6 and month 12
Number of participants screened for social needs intervention compared to control
Number of referrals to community based organization by primary care clinic
Time frame: Baseline, month 6 and month 12
Number of referrals to community based organization in intervention compared to control
3 secondary outcomes
Change in Status of social needs
Time frame: Baseline, month 6 and month 12
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) -29
Time frame: Baseline, month 6 and month 12
Percent of participants with A1c greater than or equal to 9.0%
Time frame: Baseline, month 6 and month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Lacy Leigh, PhD contact
Beth Lacy Leigh principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-Clinical Intervention in people with Diabetes and Diabetes Mellitus, run by Mary Lacy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carol R White, MPH (859-562-2684, crwhit3@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants screened for social needs (time frame: Baseline, month 6 and month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.