Interactive Computer-adaptive Chronic Kidney Disease Education Program

NCT06364358 | Recruiting

• 2 other identifiers: IRB23-03855R21DK121262
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Kidney Diseases; Hypertension

Keywords

African American; Hospitalized; Patient education

Outcome Measures

Primary Outcomes (3)

• Change in CKD Knowledge baseline to post patient education intervention

  The Kidney Disease Knowledge Questionnaire (KIKS) is a validated instrument that assesses CKD knowledge. Scores range from 0 (no knowledge)-28 (full knowledge). Change =Post intervention-Baseline scores

  Baseline and 1 day post-intervention

• Change in Knowledge about end stage kidney disease (ESKD) treatments from baseline to 1 day post patient education intervention

  The Kidney Failure Treatment Knowledge is an investigator developed tool that assesses knowledge of 6 ESKD treatment options using a Likert scale (0=no knowledge and 4=a great deal of knowledge). Possible scores range from 0-24

  Baseline and 1 day post-intervention

• Change in ESKD Treatment Preferences from baseline to 1 day post-intervention

  The Kidney Failure Treatment Preferences Survey is an investigator developed tool that assess change in certainty of preference for each of six ESKD treatments. Scores range -12 to 12 with each question scored as -2 extremely unlikely to choose a modality to +2 extremely likely to choose a modality with a change from 0 (in any direction) as an increase in certainty.

  Baseline and 1 day post-intervention

Secondary Outcomes (3)

• Change in Patient Activation Measure from Baseline to 30 days Post-intervention

  Baseline, 1 day post-intervention, and 30 day follow-up

• Increase in Health Intent baseline to post intervention (at 1 day and 30 day follow-up)

  Baseline, 1 day post-intervention and 30 day follow-up

• CKD Self-Management from baseline to 30 day post-intervention

  Baseline and 30 day follow-up

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Usual Hospital Care

Computerized Patient Education

EXPERIMENTAL

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.

Behavioral: Computerized CKD Education

Interventions

Computerized CKD Education 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.

Computerized Patient Education

Usual Hospital Care 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

Usual Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40245387 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

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; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Milda Saunders, MD

  Associate Professor of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Milda Saunders, MD

CONTACT

7737025941; msaunder@bsd.uchicago.edu

Akilah King, MSW

CONTACT

Akilah.King@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: April 15, 2024
• Study Start: May 31, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 8, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available 12 months after study completion and will remain available for 24 months
• Access Criteria: Require researcher data plan and institutional review board (IRB) approval

Locations

US (1)