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

Overview

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.

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)]
• Kidney Disease Knowledge Survey [Time frame: From enrollment to study completion (2-3 months)]
• CKD Self Efficacy Instrument [Time frame: From enrollment to study completion (2-3 months)]
• Social referral uptake [Time frame: From enrollment to study completion (2-3 months)]

Secondary outcome measures (7)

• 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)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07210710 · 2025-0858 · P30DK092949

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗