Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy — iPREP RRT  

Hypertension Clinical Trial

Official title: Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy

Status Not yet recruiting

Clinical Trial Summary

Intensive Patient Referral and Education Program prior to Renal Replacement Therapy (iPREP RRT) is a 12-week intervention that identifies hospitalized African Americans with advanced chronic kidney disease(CKD) and provides them with hospital- and community-based education, navigation and self-management support. Participants will be randomized to the iPREP RRT intervention versus enhanced usual care.

Clinical Trial Description

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 CKD self-management and 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 CKD patients' initiation and maintenance of CKD self-management and RRT planning, compared to enhanced usual care (attention controls).

Our ultimate goal is to improve knowledge and outcomes for African American patients with advanced CKD through the iPREP RRT. To accomplish this goal, we will 1) 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 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 CKD patients' initiation and maintenance of CKD self-management and RRT planning, compared to enhanced usual care. To that end, we will conduct a one-site randomized controlled trial, where patients 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). ;

Related Conditions & MeSH terms

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

• NCT number: NCT06397456
• Study type: Interventional
• Source: University of Chicago
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Completion date: December 2026