Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT06397456
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2024-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy
Sponsor:
University of Chicago
Organization:
Study Overview
Official Title:
Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iPREP-RRT
Brief 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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DK124597 | NIH | None | https://reporter.nih.gov/quic… | View |