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 — BEHAVIORAL
    In-person patient education about CKD, CKD risk factor management and renal replacement therapy options.
  • Commitment to Change — BEHAVIORAL
    Motivational interviewing to assist participants in committing to change in CKD management or RRT selection.
  • Blood pressure monitoring — BEHAVIORAL
    Participants will learn how to check their blood pressure and will receive a blood pressure cuff for home.
  • Written Patient Education — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    Patient 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 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.

Primary Outcome Measure

Kidney Disease Knowledge Questionnaire (KIKS) [ Time Frame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637
Milda Saunders, MD
773-702-5941
Akilah King, MSW
Milda R. Saunders, MD (PRINCIPAL_INVESTIGATOR)

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