Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06397456

Conditions

Chronic Kidney Disease

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

In-Person Patient Education

Commitment to Change

Blood pressure monitoring

Written Patient Education

Text-based reinforcement for CKD self-management

Study Details

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.

Conditions

Chronic Kidney Disease

Hypertension

Study ID

NCT06397456

Start date

Sep 4, 2024

Status verified date

Oct, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients over the age of 18 and under 70
  • 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:

  • Non-English speaking
  • 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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

In-Person Patient Education

In-person patient education about CKD, CKD risk factor management and renal replacement therapy options.

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

Primary outcome measure

  • Kidney Disease Knowledge Questionnaire (KIKS) [ Time Frame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16 ]
  • ESRD Knowledge [ Time Frame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16 ]
  • Blood Pressure Knowledge [ Time Frame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16 ]
  • CKD Self-Management [ Time Frame: Baseline, Week 8, Week 12, Week 16 ]

Central Contacts and Locations

Locations

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Milda Saunders, MD

773-702-5941msaunders@uchicago.edu

Akilah King, MSW

Akilah.King@bsd.uchicago.edu

Principal Investigator:

Milda R. Saunders, MD

More Information

Sponsor

University of Chicago

Last update posted

Nov 14, 2025

Last verified

Oct, 2025

Keywords

  • Hospitalized Patients
  • African American
  • Motivational Interviewing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-11-14.