CKD Awareness, Referrals, Education, and Support Intervention for Early-Stage CKD

NCT07210710 | Not Yet Recruiting DMC

• 2 other identifiers: 2025-0858P30DK092949
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Is this intervention feasible to deliver and acceptable to patients?
2. 2.What is the impact of the intervention on patient motivation, self-efficacy, kidney disease knowledge, and use of support services referrals?

Conditions

Chronic Kidney Disease; Diabetes

Keywords

chronic kidney disease; diabetes; chronic disease self-management; disease awareness; intervention; social determinants of health; motivation

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  From enrollment to study completion (2-3 months)

Secondary Outcomes (7)

• Brief Illness Perceptions Questionnaire

  From enrollment to study completion (2-3 months)

• Patient activation Measure

  From enrollment to study completion (2-3 months)

• PROMIS Medication Adherence Scale

  From enrollment to study completion (2-3 months)

• Dialysis Diet and Fluid Non-adherence Questionnaire

  From enrollment to study completion (2-3 months)

• International Physical Activity Questionnaire

  From enrollment to study completion (2-3 months)

Study Arms (2)

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.

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.

Behavioral: Attention control

Interventions

CKD Awareness, Referrals, Education, and Support (CARES) BEHAVIORAL

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.

Intervention group

Attention control BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• CKD of congenital or pediatric onset
• history of kidney transplant
• cognitive impairment as documented in the medical record

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Chicago: collaborator

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus

Interventions

Referral and Consultation; Educational Status; Palliative Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration; Socioeconomic Factors; Population Characteristics; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: October 7, 2025
• Study Start: November 15, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: All data will be shared the end of the award period or the time of an associated publication, whichever comes first. Publication-specific data will be shared when the pre-print is available. A DOI will aid in findability and the DOI will be included in relevant publications whenever possible. Study data deposited in INDIGO will be available to the research community in perpetuity.
• Access Criteria: Users of the public use data must register with INDIGO and agree to the Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of any disclosure of study participant identity. Data users also agree not to share or redistribute any data downloads.