Interactive Computer-adaptive Chronic Kidney Disease Education Program

NCT ID: NCT06364358

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2026-09-30

Brief Summary

The goal of this pilot clinical trial is to evaluate a culturally tailored computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The main question it aims to answer are: does computerized adaptive education (CAE) increase patients' knowledge about CKD self-care and renal replacement therapy (RRT) options compared to usual care (UC) and will CAE will be increase patients' intent to participate in CKD self-care and RRT preparation compared to UC

Detailed Description

The goal of this pilot clinical trial is to evaluate a culturally tailored adaptive computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The investigator's first hypothesis is that computerized adaptive education (CAE) will be more effective than standard of care in improving knowledge about self-care for advanced CKD and renal replacement therapy (RRT) options (Primary Outcome). The primary outcome is knowledge about CKD and knowledge about RRT. The study team will measure this using the Kidney Disease Knowledge Survey (KiKs). The investigator's second hypothesis is that CAE will increase patients' intent to participate in CKD self-care (to take diabetes and/or hypertension meds, see a nephrologist, and make additional lifestyle changes like smoking cessation, exercise, low-salt diet) compared to standard of care. The study team will measure this using an investigator-developed Health Intent Survey and measure patient activation through the Patient Activation Measure (PAM). Similarly, the investigator hypothesizes that CAE will increase patients' intent to obtain non-catheter access prior to dialysis initiation, to initiate self-care dialysis (peritoneal (PD) or home hemodialysis (HHD), and/or have transplant evaluation compared to standard of care. The study team will measure this using an investigator-developed Health Intent Survey. The investigator's final hypothesis is that CAE will increase patients' action at 30 days post-discharge in participating in CKD self-care and CKD health-seeking behavior compared to standard of care controls.

Conditions

Chronic Kidney Diseases; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Usual Care

The research assistant (RA) will use tablet to give participants baseline General Health Knowledge and Intent survey and leave printed patient education materials about general health maintenance. In the initial consent, pre-intervention survey and education materials, investigators will not provide CKD specific knowledge or inform participants about their CKD.

Group Type: ACTIVE_COMPARATOR

Usual Hospital Care

Intervention Type: BEHAVIORAL

Computer based patient education materials about general healthy lifestyle that will include information about the importance of a healthy diet, physical activity and medical adherence

Computerized Patient Education

The RA will assist participants in starting the computer program and encourage review of the advanced CKD education module. The computer-adaptive education module will alter the content of education topics based on some preliminary participant information.

Group Type: EXPERIMENTAL

Computerized CKD Education

Intervention Type: BEHAVIORAL

The intervention is a culturally tailored computer-based adaptive program (developed during this intervention) to educate patients about kidney disease and renal replacement therapy options.

Interventions

Computerized CKD Education

The intervention is a culturally tailored computer-based adaptive program (developed during this intervention) to educate patients about kidney disease and renal replacement therapy options.

Intervention Type: BEHAVIORAL

Usual Hospital Care

Computer based patient education materials about general healthy lifestyle that will include information about the importance of a healthy diet, physical activity and medical adherence

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• African-American inpatients
• Ages 18-70
• estimated glomerular filtration rate (eGFR)<45
• Enrolled in the Hospitalist Project

Exclusion Criteria

• Does not self-identify as African American
• Not able to consent
• Unable to speak English
• eGFR <45 due to acute kidney injury
• In Intensive Care Unit
• has had a transplant
• currently on dialysis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 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: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Milda Saunders, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Medicine

Locations

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Milda Saunders, MD

Role: CONTACT

msaunder@bsd.uchicago.edu

7737025941

Akilah King, MSW

Role: CONTACT

Akilah.King@bsd.uchicago.edu

Facility Contacts

Milda Saunders, MD

Role: primary

msaunders@uchicago.edu

773-702-5941

Akilah King, MSW

Role: backup

Akilah.King@bsd.uchicago.edu

References

King A, Omoniyi T, Zasadzinski L, Gaspard C, Gorman D, Saunders M. Interactive Computer-Adaptive Chronic Kidney Disease (I-C-CKD) Education for Hospitalized African American Patients: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 17;14:e66846. doi: 10.2196/66846.

Reference Type: DERIVED

PMID: 40245387 (View on PubMed)

Other Identifiers

5R21DK121262

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB23-0385

Identifier Type: -

Identifier Source: org_study_id