Clinical trial NCT06364358: Interactive Computer-adaptive Chronic Kidney Disease Education Program
Official title: A Pilot to Develop and Test an Interactive Computer-adaptive Chronic Kidney Disease Education Program for Hospitalized African American Patients (I-C-CKD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Hypertension
Keywords: African American
Hospitalized
Patient education
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-04-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in CKD Knowledge baseline to post patient education intervention
timeFrame: Baseline and 1 day post-intervention
measure: Change in Knowledge about end stage kidney disease (ESKD) treatments from baseline to 1 day post patient education intervention
timeFrame: Baseline and 1 day post-intervention
measure: Change in ESKD Treatment Preferences from baseline to 1 day post-intervention
timeFrame: Baseline and 1 day post-intervention
Secondary outcomes:
measure: Change in Patient Activation Measure from Baseline to 30 days Post-intervention
timeFrame: Baseline, 1 day post-intervention, and 30 day follow-up
measure: Increase in Health Intent baseline to post intervention (at 1 day and 30 day follow-up)
timeFrame: Baseline, 1 day post-intervention and 30 day follow-up
measure: CKD Self-Management from baseline to 30 day post-intervention
timeFrame: Baseline and 30 day follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: Associate Professor of Medicine
name: Milda Saunders, MD
role: PRINCIPAL_INVESTIGATOR
References: