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

University of Illinois

Status: Not yet enrolling

Conditions: Chronic Kidney Disease; Diabetes

Treatments: Behavioral: CKD Awareness, Referrals, Education, and Support (CARES); Behavioral: Attention control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07210710

2025-0858

P30DK092949 (U.S. NIH Grant/Contract)

Details and patient eligibility

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. 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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

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

Control group

Active Comparator group

Description:

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

Treatment:

Behavioral: Attention control