Chronic Kidney DiseaseiPREP-RRTNCT06397456
Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy
A study testing In-Person Patient Education, Commitment to Change and Blood pressure monitoring in people with Chronic Kidney Disease and Hypertension, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease, Hypertension
- What is being tested?
- In-Person Patient Education, Commitment to Change and Blood pressure monitoring
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Milda Saunders, MD, 773-702-5941, msaunders@uchicago.edu
Akilah King, MSW, Akilah.King@bsd.uchicago.edu
About this study
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.
Read the detailed description
The Intensive Patient Referral and Education Program prior to Renal Replacement Therapy (iPREP-RRT) will determine the efficacy of the hospital-based patient intervention (HPI) in improving patient knowledge, self-efficacy, and intent for chronic kidney disease (CKD) self-management and renal replacement therapy (RRT) planning; and 2) determine the efficacy of the community-based patient intervention (CPI) during a 12 week outpatient follow-up program that combines outpatient follow-up with multiple modes of communication (in-person session, phone calls and personalized text messaging) and navigation in increasing participants' initiation and maintenance of CKD self-management and RRT planning, compared to enhanced usual care (attention controls).
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
- Chronic Kidney Disease, Hypertension
- Being tested
- In-Person Patient Education, Commitment to Change, Blood pressure monitoring, Written Patient Education, Text-based reinforcement for CKD self-management
- Keywords
- Hospitalized Patients, African American, Motivational Interviewing
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person Patient EducationBehavioural
In-person patient education about CKD, CKD risk factor management and renal replacement therapy options.
Commitment to ChangeBehavioural
Motivational interviewing to assist participants in committing to change in CKD management or RRT selection.
Blood pressure monitoringBehavioural
Participants will learn how to check their blood pressure and will receive a blood pressure cuff for home.
Written Patient EducationBehavioural
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-managementBehavioural
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-managementBehavioural
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-managementBehavioural
Patient educator will use text messages to send general health management messages
| Study group | Role | What they receive |
|---|---|---|
| Intensive Intervention (iPREP RRT) | Experimental | 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. Receives: Behavioral: In-Person Patient Education; Behavioral: Commitment to Change; Behavioral: Blood pressure monitoring; Behavioral: Text-based reinforcement for CKD self-management; Behavioral: Community-based education session, reinforcement for self-management |
| Enhanced Usual Care | Placebo comparator | 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. Receives: Behavioral: Written Patient Education; Behavioral: Text-based reinforcement for general health self-management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney Disease Knowledge Questionnaire (KIKS)
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
Measured: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16
ESRD Knowledge
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
Measured: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16
Blood Pressure Knowledge
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
Measured: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16
CKD Self-Management
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
Measured: Baseline, Week 8, Week 12, Week 16
Secondary outcomes (2)
CKD Self-Efficacy
CKD Self-Efficacy Scale (CKD-SE), 25-item CKD-SE instrument can be used for the early identification of patients with low self-efficacy. The scale is from 0 to 10 points, and a larger number indicates a higher level of confidence regarding the management activity. The total score on the scale ranges between 25 and 250. The total score can be classified into three categories: low self-efficacy (score less than 30), moderate (scores between 30 to 70), and high self-efficacy (score more than 70). Change is Follow-up Score (Week 8, Week 12, Week 16)-Baseline
Measured: Baseline, 1 day Post Brief Intervention, Week 4, Week 8, Week 12, Week 16
CKD Health Intent
The Health Intent Survey is an investigator-developed tool to measure participants stated intent to make healthy lifestyle changes. There are 12 questions each scored on a 5 point scale from 1=extremely unlikely to 5=extremely likely (60 total possible points with higher scores better). Change=Follow-up (1 day post-intervention, Wk4, wk 8, wk 12, wk16) - baseline.
Measured: Baseline, 1 day Post-Brief Intervention, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start4 Sep 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397456
- Sponsor's protocol ID
- IRB20-1663
- Other IDs
- R01DK124597
- Acronym
- iPREP-RRT
- Status last verified
- Oct 2025
- First submitted
- 30 Apr 2024
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will share de-identified, aggregate data with other researchers. Additional sharing not permitted by current IRB permission.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT06397456
- Acronym / sponsor ID
- iPREP-RRT / IRB20-1663
- Conditions
- Chronic Kidney Disease, Hypertension
- Keywords
- Hospitalized Patients, African American, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Intensive Patient Referral and Education Program prior to Renal Replacement Therapy (iPREP-RRT) will determine the efficacy of the hospital-based patient intervention (HPI) in improving patient knowledge, self-efficacy, and intent for chronic kidney disease (CKD) self-management and renal replacement therapy (RRT) planning; and 2) determine the efficacy of the community-based patient intervention (CPI) during a 12 week outpatient follow-up program that combines outpatient follow-up with multiple modes of communication (in-person session, phone calls and personalized text messaging) and navigation in increasing participants' initiation and maintenance of CKD self-management and RRT planning, compared to enhanced usual care (attention controls).
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Intervention (iPREP RRT) | Experimental | Behavioral: In-Person Patient Education, Behavioral: Commitment to Change, Behavioral: Blood pressure monitoring, Behavioral: Text-based reinforcement for CKD self-management, Behavioral: Community-based education session, reinforcement for self-managementThe 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. |
| Enhanced Usual Care | Placebo comparator | Behavioral: Written Patient Education, Behavioral: Text-based reinforcement for general health self-managementThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Person Patient EducationIn-person patient education about CKD, CKD risk factor management and renal replacement therapy options. | Behavioural | Intensive Intervention (iPREP RRT) |
| Commitment to ChangeMotivational interviewing to assist participants in committing to change in CKD management or RRT selection. | Behavioural | Intensive Intervention (iPREP RRT) |
| Blood pressure monitoringParticipants will learn how to check their blood pressure and will receive a blood pressure cuff for home. | Behavioural | Intensive Intervention (iPREP RRT) |
| Written Patient EducationWritten patient education booklet about general health care management including taking medications, having a primary care doctor, weight management and exercise. | Behavioural | Enhanced Usual Care |
| Text-based reinforcement for CKD self-managementPatient 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 | Behavioural | Intensive Intervention (iPREP RRT) |
| Community-based education session, reinforcement for self-managementPatient 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 | Behavioural | Intensive Intervention (iPREP RRT) |
| Text-based reinforcement for general health self-managementPatient educator will use text messages to send general health management messages | Behavioural | Enhanced Usual Care |
Primary outcome
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
2 secondary outcomes
CKD Self-Efficacy
Time frame: Baseline, 1 day Post Brief Intervention, Week 4, Week 8, Week 12, Week 16
CKD Health Intent
Time frame: Baseline, 1 day Post-Brief Intervention, Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: No. Will share de-identified, aggregate data with other researchers. Additional sharing not permitted by current IRB permission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Person Patient Education, Commitment to Change and Blood pressure monitoring in people with Chronic Kidney Disease and Hypertension, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney Disease Knowledge Questionnaire (KIKS) (time frame: Baseline, 1 day Post Brief Intervention, Week 4, Week 12, Week 16). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.