Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- University of Chicago
- Study ID
- NCT06397456
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- In-Person Patient Education — BEHAVIORALIn-person patient education about CKD, CKD risk factor management and renal replacement therapy options.
- Commitment to Change — BEHAVIORALMotivational interviewing to assist participants in committing to change in CKD management or RRT selection.
- Blood pressure monitoring — BEHAVIORALParticipants will learn how to check their blood pressure and will receive a blood pressure cuff for home.
- Written Patient Education — BEHAVIORALWritten 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 — BEHAVIORALPatient 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 — BEHAVIORALPatient 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 — BEHAVIORALPatient educator will use text messages to send general health management messages
Study Details
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.
Key Dates
- Start date
- Sep 4, 2024
- Status verified
- Oct 2025
- Primary completion
- Apr 30, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 180 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: 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.
- Placebo Comparator: Enhanced Usual CareThe 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.
Primary Outcome Measure
Kidney Disease Knowledge Questionnaire (KIKS) [ Time Frame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | Akilah King, MSW Milda R. Saunders, MD (PRINCIPAL_INVESTIGATOR) |
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