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Clinical Trials/NCT06364358
NCT06364358
Recruiting
Not Applicable

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

University of Chicago1 site in 1 country120 target enrollmentMay 31, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Diseases
Sponsor
University of Chicago
Enrollment
120
Locations
1
Primary Endpoint
Change in Knowledge about end stage kidney disease (ESKD) treatments from baseline to 1 day post patient education intervention
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 31, 2023
End Date
September 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

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

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

  • 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 Sites (1)

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