Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy
NCT ID: NCT06397456
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2024-09-04
2026-06-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Intensive Intervention (iPREP RRT)
The intervention is administered by a patient educator (PE), a culturally concordant health educator. S/he will review the CKD and RRT education materials on a tablet device with the participant, answer any questions they have, and using motivational interviewing techniques get a commitment for future action. The participant and the patient educator will work together to decide on potential CKD self-management and RRT options and/or next steps. The PE will teach the participant how to use the home blood pressure monitor and will leave it with the participant.
The patient educator will check in with the participant through text messages and follow-up phone calls.
Commitment to Change
Motivational interviewing to assist participants in committing to change in CKD management or RRT selection.
Blood pressure monitoring
Participants will learn how to check their blood pressure and will receive a blood pressure cuff for home.
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
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
In-Person Patient Education
In-person patient education about CKD, CKD risk factor management and renal replacement therapy options.
Enhanced Usual Care
The enhanced usual care is administered by a patient educator (PE), a culturally concordant health educator. The PE will drop off written general health education materials.
The patient educator will check in with the participant through text messages.
Written Patient Education
Written patient education booklet about general health care management including taking medications, having a primary care doctor, weight management and exercise.
Text-based reinforcement for general health self-management
Patient educator will use text messages to send general health management messages
Interventions
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Commitment to Change
Motivational interviewing to assist participants in committing to change in CKD management or RRT selection.
Blood pressure monitoring
Participants will learn how to check their blood pressure and will receive a blood pressure cuff for home.
Written Patient Education
Written patient education booklet about general health care management including taking medications, having a primary care doctor, weight management and exercise.
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
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
Text-based reinforcement for general health self-management
Patient educator will use text messages to send general health management messages
In-Person Patient Education
In-person patient education about CKD, CKD risk factor management and renal replacement therapy options.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Chicago
OTHER
Responsible Party
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Locations
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University of Chicago Medical Center
Chicago, Illinois, United States
Countries
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Facility Contacts
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Milda Saunders, MD
Role: primary
Akilah King, MSW
Role: backup
Other Identifiers
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IRB20-1663
Identifier Type: -
Identifier Source: org_study_id