NCT06397456

Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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).

Conditions

• Chronic Kidney Disease
• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	In-Person Patient Education	In-person patient education about CKD, CKD risk factor management and renal replacement therapy options.
BEHAVIORAL	Commitment to Change	Motivational interviewing to assist participants in committing to change in CKD management or RRT selection.
BEHAVIORAL	Blood pressure monitoring	Participants will learn how to check their blood pressure and will receive a blood pressure cuff for home.
BEHAVIORAL	Written Patient Education	Written patient education booklet about general health care management including taking medications, having a primary care doctor, weight management and exercise.
BEHAVIORAL	Text-based reinforcement for CKD self-management	Patient educator will use text messages based on social cognitive theory to remind participants about and reinforce goals set around CKD self-management, blood pressure control and RRT selection
BEHAVIORAL	Community-based education session, reinforcement for self-management	Patient educator will use provide a "booster" session based on social cognitive theory to remind participants about and reinforce goals set around CKD self-management, blood pressure control and RRT selection
BEHAVIORAL	Text-based reinforcement for general health self-management	Patient educator will use text messages to send general health management messages

Timeline

• Start date: 2024-09-04
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2024-05-03
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States