Chronic Kidney DiseaseCARESNCT07210710
CKD Awareness, Referrals, Education, and Support Intervention for Early-Stage CKD
A study testing CKD Awareness, Referrals, Education, and Support (CARES) in people with Chronic Kidney Disease and Diabetes, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Diabetes
- What is being tested?
- CKD Awareness, Referrals, Education, and Support (CARES)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2025to 31 Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- CKD of congenital or pediatric onset
- history of kidney transplant
- cognitive impairment as documented in the medical record
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Chicago Hospital
Chicago, Illinois, 60612
Eleanor Rivera Study PI, 312-996-7972, caresckd@uic.edu
About this study
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:
- Is this intervention feasible to deliver and acceptable to patients?
- What is the impact of the intervention on patient motivation, self-efficacy, kidney disease knowledge, and use of support services referrals?
Read more
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.
Read the detailed description
Chronic kidney disease (CKD) progression to kidney failure causes devastating declines in quality of life and mortality, with high healthcare costs. CKD affects ~15% of all adults in the U.S. and ~40% of adults with diabetes, with substantial variability in rate of progression to kidney failure. Negative social determinants of health (SDOH), such as food insecurity can speed up disease progression. However, if CKD progression to kidney failure can be prevented or delayed, patients can experience minimal impact on health and well-being. The diagnosis, treatment, and monitoring of early-stage, asymptomatic CKD occurs predominantly in the primary care setting, including for those with diabetes. Unfortunately, the rates of guideline-based CKD care delivery are low, and as a result, clinical diagnosis of early-stage CKD is as low as 50%. Delay in receiving a CKD diagnosis is associated with faster progression to kidney failure. Furthermore, because CKD is not always prioritized in the busy primary care setting, most patients are unaware they have CKD and have low rates of CKD knowledge, which impedes their ability to adhere to treatment. To address the issues of underdiagnosis, patients' lack of disease knowledge and self-efficacy, and the impact of SDOH for patients with diabetes and CKD, proactive action is critical. The investigators will target patients with diabetes who are eligible for an early-stage CKD diagnosis with a nurse-led, pre-primary care-visit 1:1 virtual session including evidence-based CKD education, motivational interviewing, and SDOH screening with referrals to services.
- Conditions
- Chronic Kidney Disease, Diabetes
- Being tested
- CKD Awareness, Referrals, Education, and Support (CARES), Attention control
- Keywords
- chronic kidney disease, diabetes, chronic disease self-management, disease awareness, intervention, social determinants of health, motivation
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD Awareness, Referrals, Education, and Support (CARES)Behavioural
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.
Attention controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will participate in a nurse-led virtual session delivering education about chronic kidney disease, motivational interviewing to set a self-management goal, and screening/referral for social determinants of health barriers to treatment adherence and engagement. Receives: Behavioral: CKD Awareness, Referrals, Education, and Support (CARES) |
| Control group | Active comparator | The attention control group will participate in a nurse-led virtual session delivering general information about diabetes and treatment. Receives: Behavioral: Attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation for diabetes-related self-care behaviour scale
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).
Measured: From enrollment to study completion (2-3 months)
Kidney Disease Knowledge Survey
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.
Measured: From enrollment to study completion (2-3 months)
CKD Self Efficacy Instrument
Participant self-report. The scale ranges from 1-10, with low scores indicating not at all confident and high scores indicating totally confident.
Measured: From enrollment to study completion (2-3 months)
Social referral uptake
Participant self-report of uptake of any support services for barriers to treatment adherence that are needed.
Measured: From enrollment to study completion (2-3 months)
Secondary outcomes (7)
Brief Illness Perceptions Questionnaire
Participant self-report. Scale from 1-10, with the meaning of numbers changing per item. Assessing participants' perspective and understanding of their chronic condition. Items assessed individually or using clustering approaches.
Measured: From enrollment to study completion (2-3 months)
Patient activation Measure
Participant self-report. Scales are 1-4 with a not applicable option, lower scores meaning less activated and engaged in care and higher scores meaning more activated and engaged in care.
Measured: From enrollment to study completion (2-3 months)
PROMIS Medication Adherence Scale
Participant self-report. Scale from 1-5 indicating agree to disagree, with items about performance of medication adherence behaviors.
Measured: From enrollment to study completion (2-3 months)
Dialysis Diet and Fluid Non-adherence Questionnaire
Participant self-report. One item asking how many days in the last week guidelines were not followed, and another item asking to what degree they were not followed, from completely to not at all.
Measured: From enrollment to study completion (2-3 months)
International Physical Activity Questionnaire
Participant self-report. Scale is 1-7 indicating the number of days a type of physical activity was performed in the previous week. Items are different types of physical activity behaviors.
Measured: From enrollment to study completion (2-3 months)
Care plan changes
review of EHR data related to PCP visit, assess if any CKD-related information or changes were documented
Measured: From enrollment to study completion (2-3 months)
Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences
Participant self-report. Items and response options vary and ask questions about social determinants of health issues (e.g., food insecurity, housing insecurity). Screening tool with no scores.
Measured: From enrollment to study completion (2-3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start15 Nov 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Chicago
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210710
- Sponsor's protocol ID
- 2025-0858
- Other IDs
- P30DK092949
- Acronym
- CARES
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected from participants includes: demographic, clinical history characteristics, comorbidity data, and new diagnoses or treatment plan changes will be collected through electronic medical record (EMR) abstraction. Social determinants of health barriers and uptake, self-efficacy, patient activation, motivation, treatment adherence, CKD knowledge, and CKD perceptions, feasibility, and acceptability quantitative data will be acquired through self-report questionnaires. All data will be collected in REDCap and de-identified prior to receipt by the repository, and a unique study identifier will be created for each subject. All deidentified quantitative study data that are not designated as restricted use by our repository, INtellectual property in DIGital form available online in an Open environment (INDIGO), will be shared openly.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CKD Awareness, Referrals, Education, and Support Intervention for Early-Stage CKD
- ClinicalTrials.gov ID
- NCT07210710
- Acronym / sponsor ID
- CARES / 2025-0858
- Conditions
- Chronic Kidney Disease, Diabetes
- Keywords
- chronic kidney disease, diabetes, chronic disease self-management, disease awareness, intervention, social determinants of health, motivation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Chicago
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 7 Oct 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.
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:
- Is this intervention feasible to deliver and acceptable to patients?
- 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.
Detailed description
Chronic kidney disease (CKD) progression to kidney failure causes devastating declines in quality of life and mortality, with high healthcare costs. CKD affects ~15% of all adults in the U.S. and ~40% of adults with diabetes, with substantial variability in rate of progression to kidney failure. Negative social determinants of health (SDOH), such as food insecurity can speed up disease progression. However, if CKD progression to kidney failure can be prevented or delayed, patients can experience minimal impact on health and well-being. The diagnosis, treatment, and monitoring of early-stage, asymptomatic CKD occurs predominantly in the primary care setting, including for those with diabetes. Unfortunately, the rates of guideline-based CKD care delivery are low, and as a result, clinical diagnosis of early-stage CKD is as low as 50%. Delay in receiving a CKD diagnosis is associated with faster progression to kidney failure. Furthermore, because CKD is not always prioritized in the busy primary care setting, most patients are unaware they have CKD and have low rates of CKD knowledge, which impedes their ability to adhere to treatment. To address the issues of underdiagnosis, patients' lack of disease knowledge and self-efficacy, and the impact of SDOH for patients with diabetes and CKD, proactive action is critical. The investigators will target patients with diabetes who are eligible for an early-stage CKD diagnosis with a nurse-led, pre-primary care-visit 1:1 virtual session including evidence-based CKD education, motivational interviewing, and SDOH screening with referrals to services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: CKD Awareness, Referrals, Education, and Support (CARES)Participants will participate in a nurse-led virtual session delivering education about chronic kidney disease, motivational interviewing to set a self-management goal, and screening/referral for social determinants of health barriers to treatment adherence and engagement. |
| Control group | Active comparator | Behavioral: Attention controlThe attention control group will participate in a nurse-led virtual session delivering general information about diabetes and treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- CKD of congenital or pediatric onset
- history of kidney transplant
- cognitive impairment as documented in the medical record
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 |
|---|---|---|
| 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. | Behavioural | Intervention group |
| Attention controlThe 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. | Behavioural | Control group |
Primary outcome
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.
7 secondary outcomes
Brief Illness Perceptions Questionnaire
Time frame: From enrollment to study completion (2-3 months)
Patient activation Measure
Time frame: From enrollment to study completion (2-3 months)
PROMIS Medication Adherence Scale
Time frame: From enrollment to study completion (2-3 months)
Dialysis Diet and Fluid Non-adherence Questionnaire
Time frame: From enrollment to study completion (2-3 months)
International Physical Activity Questionnaire
Time frame: From enrollment to study completion (2-3 months)
Care plan changes
Time frame: From enrollment to study completion (2-3 months)
Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences
Time frame: From enrollment to study completion (2-3 months)
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 9 Oct 2026.
- Individual participant dataSharing planned: Yes. Data collected from participants includes: demographic, clinical history characteristics, comorbidity data, and new diagnoses or treatment plan changes will be collected through electronic medical record (EMR) abstraction. Social determinants of health barriers and uptake, self-efficacy, patient activation, motivation, treatment adherence, CKD knowledge, and CKD perceptions, feasibility, and acceptability quantitative data will be acquired through self-report questionnaires. All data will be collected in REDCap and de-identified prior to receipt by the repository, and a unique study identifier will be created for each subject. All deidentified quantitative study data that are not designated as restricted use by our repository, INtellectual property in DIGital form available online in an Open environment (INDIGO), will be shared openly.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CKD Awareness, Referrals, Education, and Support (CARES) in people with Chronic Kidney Disease and Diabetes, run by University of Illinois Chicago 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?
The sponsor lists 5 inclusion and 3 exclusion criteria. 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 9 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivation for diabetes-related self-care behaviour scale (time frame: From enrollment to study completion (2-3 months)). The study lists 4 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 9 Oct 2026.