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

NCT ID: NCT07210710

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-15
• Study Completion Date: 2026-07-31

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. 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Control group

The attention control group will participate in a nurse-led virtual session delivering general information about diabetes and treatment.

Group Type: ACTIVE_COMPARATOR

Attention control

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P30DK092949

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025-0858

Identifier Type: -

Identifier Source: org_study_id