Community-Clinical Intervention for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach to help people with diabetes in rural Kentucky manage their health more effectively. It combines healthcare support with community resources to address both medical and social needs, such as finding local services and support groups. Participants will either receive usual care or join a group that receives additional help from community health workers and technology tools as part of the Community-Clinical Intervention. This trial suits individuals diagnosed with diabetes who are patients at specific clinics in Kentucky. As an unphased trial, it offers a unique opportunity for patients to contribute to innovative healthcare solutions tailored to their community.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this community-clinical intervention is safe for patients with diabetes?
A previous study demonstrated good results for the community-clinical program in everyday settings. Research shows that this method can save money and improve health for people with diabetes. Other studies have found that using community health workers and technology to connect patients with resources helps manage diabetes more effectively. Reports have not indicated any serious side effects from this type of program, suggesting it is safe for participants.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it tackles diabetes management by addressing unmet social needs, which isn't a focus in standard care. Unlike typical treatments that concentrate on medication and lifestyle changes, this approach integrates patient navigation with the help of Community Health Workers and leverages health information technology to connect patients with local resources. This community-clinical intervention aims to improve health outcomes by linking clinical care with community support, potentially offering a more comprehensive solution for managing diabetes, especially in underserved rural areas.
What evidence suggests that this community-clinical intervention is effective for diabetes?
Research has shown that collaborating with community groups and clinics can manage diabetes more effectively. In this trial, one group of participants will receive a Community-Clinical Intervention, which includes support from community health workers (CHWs). Patients with CHW support tend to have better control of their A1C levels, a measure of blood sugar over time. Another study found that peer support in the community improved blood sugar levels, body weight, and mood. Additionally, mobile health tools provided by healthcare professionals helped control blood sugar more effectively. These findings suggest that integrating community resources with clinical care can lead to better diabetes outcomes.36789
Who Is on the Research Team?
Beth Lacy Leigh
Principal Investigator
University of Kentucky
Are You a Good Fit for This Trial?
This trial is for adults over 18 with diabetes who are patients at specific clinics in rural Kentucky. It's not open to those under 18, people without diabetes, or patients from other clinics.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention Development
Community-clinical partners develop the intervention through a rapid process improvement workshop
Implementation
Implementation of the community-clinical linkage intervention in primary care clinics
Follow-up
Participants are monitored for changes in social needs, quality of life, and diabetes control
What Are the Treatments Tested in This Trial?
Interventions
- Community-Clinical Intervention
Trial Overview
The study is testing a community-clinical linkage intervention aimed at helping diabetic patients in rural areas by connecting them with resources to meet their social needs through primary care clinics.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
Clinics randomized to the control arm will receive usual care
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mary Lacy
Lead Sponsor
Centers for Disease Control and Prevention
Collaborator
Citations
Impact of community health workers on diabetes ...
Patients with CHWs were better able to manage their A1C levels than patients without CHWs, both before and after the onset of the COVID-19 ...
2.
diabetesjournals.org
diabetesjournals.org/care/article/48/5/807/158051/Community-Based-Peer-Support-for-DiabetesCommunity-Based Peer Support for Diabetes Management
This study found significant intervention effects for HbA1c as the primary outcome, as well as improvement in BMI, FPG, and depressive symptoms ...
Mobile Health Intervention in Patients With Type 2 Diabetes
This randomized clinical trial found that a clinical pharmacist and health coach–delivered mHealth intervention improved HbA1c levels in African ...
4.
bmcpublichealth.biomedcentral.com
bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-22627-1Community-based diabetes self-management and support ...
This study examined pre- to post-program quality of life outcomes for participants in a community-based diabetes-self management and support (DSMS) program.
The Effect of a Diabetes Collaborative Care Management ...
Further, the data suggest that the DCCM program was associated with a less substantial increase in all-cause total costs in patients with uncontrolled T2DM ...
Implementing a Clinical Intervention in Community Settings
The intervention demonstrated positive implementation outcomes. It showed both cost and clinical effectiveness, with net savings of $566 per ...
7.
diabetesjournals.org
diabetesjournals.org/care/article/46/7/1316/151548/Use-of-Real-World-Data-in-Population-Science-toUse of Real-World Data in Population Science to Improve the ...
This report reviews the current landscape and applications of RWD in clinical effectiveness and population health research for diabetes
Public Health Research and Program Strategies for ...
The findings from the DPP trial, published in 2002, indicated a 58% reduction in the risk of developing type 2 diabetes among adults with ...
Community-Clinical Linkages for Diabetes Prevention and ...
CCLs can create the necessary change in systems' policies, practices, and norms to connect people at higher risk of developing diabetes with effective ...
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