NCT06397456 · University of Chicago
Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy
(iPREP-RRT)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
In-Person Patient Education
In-person patient education about CKD, CKD risk factor management and renal replacement therapy options.
BEHAVIORAL
Commitment to Change
Motivational interviewing to assist participants in committing to change in CKD management or RRT selection.
BEHAVIORAL
Blood pressure monitoring
Participants will learn how to check their blood pressure and will receive a blood pressure cuff for home.
BEHAVIORAL
Written Patient Education
Written patient education booklet about general health care management including taking medications, having a primary care doctor, weight management and exercise.
BEHAVIORAL
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
BEHAVIORAL
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
BEHAVIORAL
Text-based reinforcement for general health self-management
Patient educator will use text messages to send general health management messages
Primary outcome measures
Kidney Disease Knowledge Questionnaire (KIKS)
Time frame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16
The Kidney Disease Knowledge Questionnaire (KIKS) is a validated instrument that assesses CKD knowledge. Scores range from 0 (no knowledge)-28 (full knowledge). Change =Post intervention-Baseline scores, and Follow-up (Week 4, Week 12, Week 16)-Baseline
ESRD Knowledge
Time frame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16
The Kidney Failure Treatment Knowledge is an investigator developed tool that assesses knowledge of 6 ESKD treatment options using a Likert scale (0=no knowledge and 4=a great deal of knowledge). Possible scores range from 0-24. Change =Post intervention-Baseline scores, and Follow-up (Week 4, Week 12, Week 16)-Baseline
Blood Pressure Knowledge
Time frame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16
Blood Pressure Knowledge Scale (BPKS, revised) is an 11-item scale; a summed score is computed. Scores range from 7 to 77 and higher scores indicate greater knowledge. Change =Post intervention-Baseline scores, and Follow-up (Week 4, Week 12, Week 16)-Baseline
CKD Self-Management
Time frame: Baseline, Week 8, Week 12, Week 16
The CKD Self-Management Knowledge Toolkit (CKD-SMKT) is a validated 10 item survey to assess participants CKD self-management behaviors. The survey consists of 2 true /false questions for each of the 10 self-care domains and can be scored from 0 (no self-care) to 20 (full self-care). Change is Follow-up Score (Week 8, Week 12, Week 16)-Baseline
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 14, 2025 · Source of record for eligibility and locations