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NCT Number: NCT06364358

Interactive Computer-adaptive Chronic Kidney Disease Education Program

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

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Key information

Conditions

Chronic Kidney Diseases Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Akilah King, MSW

CONTACT

[email protected]

Milda R. Saunders, MD

PRINCIPAL_INVESTIGATOR

Milda Saunders, MD

CONTACT

[email protected]

773-702-5941

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Change in CKD Knowledge baseline to post patient education intervention

    Time frame: Baseline and 1 day post-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

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

    Time frame: Baseline and 1 day post-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

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

    Time frame: Baseline and 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.

Secondary outcomes

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

    Time frame: Baseline, 1 day post-intervention, and 30 day follow-up

    The Patient Activation Measure (PAM) is a 10-item questionnaire that assesses an individual´s knowledge, skills, and confidence for managing their health and health care. The measure assesses individuals on a 0-100 scale that converts to one of four levels of activation, from low (1) to high (4). Change =Post intervention score (1 day and 30 day)-baseline score)

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

    Time frame: Baseline, 1 day post-intervention and 30 day follow-up

    The Health Intent Survey is an investigator-developed tool to measure participants stated intent to make healthy lifestyle changes. There are 10 questions each scored on a 5 point scale from 1=extremely unlikely to 5=extremely likely (50 total possible points with higher scores better). Change=30 day follow-up - baseline and 1 day post-intervention - baseline.

  3. CKD Self-Management from baseline to 30 day post-intervention

    Time frame: Baseline and 30 day follow-up

    The CKD Self-Management Knowledge Toolkit (CKD-SMKT) is a validated 10 item survey to assess participants CKD self-management behaviors. The survey consists of 2 true /false questions for each of the 10 self-care domains and can be scored from 0 (no self-care) to 20 (full self-care). Change is 30 day score-Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Akilah King, MSW

CONTACT

[email protected]

Milda Saunders, MD

CONTACT

[email protected]

7737025941

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

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

Registry information

Official study title

A Pilot to Develop and Test an Interactive Computer-adaptive Chronic Kidney Disease Education Program for Hospitalized African American Patients (I-C-CKD)

Acronym: ICCKD

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 15, 2024
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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