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Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy

NCT06397456 · University of Chicago
In plain English

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About this study
The Intensive Patient Referral and Education Program prior to Renal Replacement Therapy (iPREP-RRT) will determine the efficacy of the hospital-based patient intervention (HPI) in improving patient knowledge, self-efficacy, and intent for chronic kidney disease (CKD) self-management and renal replacement therapy (RRT) planning; and 2) determine the efficacy of the community-based patient intervention (CPI) during a 12 week outpatient follow-up program that combines outpatient follow-up with multiple modes of communication (in-person session, phone calls and personalized text messaging) and navigation in increasing participants' initiation and maintenance of CKD self-management and RRT planning, compared to enhanced usual care (attention controls). The goal is to improve knowledge and outcomes for African American patients with advanced CKD through the iPREP-RRT. To accomplish this goal, investigators will 1) determine the efficacy of the hospital-based patient intervention (HPI) in improving participant knowledge, self-efficacy, and intent for CKD self-management and RRT planning; and 2) determine the efficacy of the community-based patient intervention (CPI) during a 12 week outpatient program that combines outpatient follow-up with multiple modes of communication (in-person session, phone calls and personalized text messaging) and navigation in increasing initiation and maintenance of CKD self-management and RRT planning, compared to enhanced usual care. To that end, investigators will conduct a one-site randomized controlled trial, where participants will be randomized in a 1:1 ratio into either the intervention (iPREP-RRT) or control groups (enhanced usual care). The randomization will be stratified by baseline blood pressure (controlled or uncontrolled). Participants will receive 2 in-person education sessions (during hospitalization and week 12), phone sessions at weeks 4 and 8, and weekly personalized text message contact. The duration of the intervention will be 12 weeks, and participants and controls will be assessed pre-intervention, immediately post-hospital based intervention, at 4 ,8 and 12 weeks during community-based intervention and 4 weeks post-intervention (16 weeks).
Eligibility criteria
Inclusion Criteria: * Patients over the age of 18 and under 70 * Admitted to the University of Chicago inpatient general medicine service * Likely hospital stay greater than 48 hours * Diagnosis of advanced CKD (Stage 3B or above, as determine by problem list, ICD- 10 codes or eGFR\<45 during admission and from previous medical encounters) * Self-identify as Black or African American Exclusion Criteria: * Non-English speaking * Unable to communicate due to current medical status * Unable to consent due to mental status * Expected hospital stay less than 24 hour * Current admission in ICU
Study design
Enrollment target: 180 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-09-04
Estimated completion: 2026-06-30
Last updated: 2025-11-14
Interventions
Behavioral: In-Person Patient EducationBehavioral: Commitment to ChangeBehavioral: Blood pressure monitoringBehavioral: Written Patient EducationBehavioral: Text-based reinforcement for CKD self-managementBehavioral: Community-based education session, reinforcement for self-managementBehavioral: Text-based reinforcement for general health self-management
Primary outcomes
  • Kidney Disease Knowledge Questionnaire (KIKS) (Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16)
  • ESRD Knowledge (Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16)
  • Blood Pressure Knowledge (Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16)
Sponsor
University of Chicago · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
All locations (1)
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy · TrialPath