NCT07210710 · University of Illinois at Chicago
CKD Awareness, Referrals, Education, and Support Intervention for Early-Stage CKD
(CARES)
What this study is about
The goal of this pilot clinical trial is to learn if an intervention delivering education, motivational support, and social support can prevent worsening kidney disease in adults with diabetes and early-stage kidney disease. The main questions it aims to answer are: 1. Is this intervention feasible to deliver and acceptable to patients? 2.
View original scientific description
The goal of this pilot clinical trial is to learn if an intervention delivering education, motivational support, and social support can prevent worsening kidney disease in adults with diabetes and early-stage kidney disease. The main questions it aims to answer are: 1. Is this intervention feasible to deliver and acceptable to patients? 2. What is the impact of the intervention on patient motivation, self-efficacy, kidney disease knowledge, and use of support services referrals? The investigators will compare information collected about participants' response to this intervention with a group of similar patients who receive general diabetes information. Participants will meet virtually with a nurse approximately 1 week before a scheduled primary care provider visit and complete surveys over the phone three times in a period of three months.
Interventions
BEHAVIORAL
CKD Awareness, Referrals, Education, and Support (CARES)
We will target diabetic patients eligible for an early-stage CKD diagnosis with a nurse-delivered, pre-PCP-visit 1:1 virtual session including 1) tailored, evidence-based CKD education 2) motivational interviewing with self-management goal setting, and 3) social determinants of health screening with referrals to services as needed.
BEHAVIORAL
Attention control
The control group will receive an attention control session of general education about diabetes-related health behaviors (e.g., diet and physical activity) that does not refer to CKD, based on American Diabetes Association materials.
Primary outcome measures
Motivation for diabetes-related self-care behaviour scale
Time frame: From enrollment to study completion (2-3 months)
Participant self-report. A scale from 1-5, with a lower score meaning not motivated and a higher score meaning highly motivated. Items are different self-management behaviors (e.g., medication, diet, exercise).
Kidney Disease Knowledge Survey
Time frame: From enrollment to study completion (2-3 months)
Participant self-report. A set of fact-based questions about kidney disease which has a right and a wrong answer. Participants will be scored based on % correct answers.
CKD Self Efficacy Instrument
Time frame: From enrollment to study completion (2-3 months)
Participant self-report. The scale ranges from 1-10, with low scores indicating not at all confident and high scores indicating totally confident.
Social referral uptake
Time frame: From enrollment to study completion (2-3 months)
Participant self-report of uptake of any support services for barriers to treatment adherence that are needed.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- adults (18+)
- diabetes diagnosis (type 1 or 2)
- CKD Stage 3 diagnosis eligible
- \>1 prior visit at the UIHealth primary care clinics
- can speak English
Exclusion criteria
- CKD of congenital or pediatric onset
- history of kidney transplant
- cognitive impairment as documented in the medical record
Where
- Chicago, Illinois
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Chicago
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2026 · Source of record for eligibility and locations