Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397456
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-30
Brief Title:
Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy
Status:
RECRUITING
Status Verified Date:
2024-08
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 11 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 11 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK124597 | NIH | None | httpsreporternihgovquickSearchR01DK124597 |