Interactive Computer-adaptive Chronic Kidney Disease Education Program

Hypertension Clinical Trial

— ICCKD  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364358
• Other study ID #: IRB23-0385
• Secondary ID: 5R21DK121262
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• 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.
• 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

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in Patient Activation Measure from Baseline to 30 days Post-intervention	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)	Baseline, 1 day post-intervention, and 30 day follow-up
Secondary	Increase in Health Intent baseline to post intervention (at 1 day 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.	Baseline, 1 day post-intervention and 30 day follow-up
Secondary	CKD Self-Management from baseline to 30 day post-intervention	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	Baseline and 30 day follow-up