Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy

NCT06397456 | Recruiting

• 2 other identifiers: IRB20-1663R01DK124597
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

Hospitalized Patients; African American; Motivational Interviewing

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  Baseline, Week 8, Week 12, Week 16

Secondary Outcomes (2)

• CKD Self-Efficacy

  Baseline, 1 day Post Brief Intervention, Week 4, Week 8, Week 12, Week 16

• CKD Health Intent

  Baseline, 1 day Post-Brief Intervention, Week 4

Study Arms (2)

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.

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.

Behavioral: Written Patient Education; Behavioral: Text-based reinforcement for general health self-management

Interventions

In-Person Patient Education BEHAVIORAL

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

Intensive Intervention (iPREP RRT)

Commitment to Change BEHAVIORAL

Motivational interviewing to assist participants in committing to change in CKD management or RRT selection.

Intensive Intervention (iPREP RRT)

Blood pressure monitoring BEHAVIORAL

Participants will learn how to check their blood pressure and will receive a blood pressure cuff for home.

Intensive Intervention (iPREP RRT)

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.

Enhanced Usual Care

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

Intensive Intervention (iPREP RRT)

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

Intensive Intervention (iPREP RRT)

Text-based reinforcement for general health self-management BEHAVIORAL

Patient educator will use text messages to send general health management messages

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Interventions

Blood Pressure Monitors; Self-Management

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sphygmomanometers; Diagnostic Equipment; Equipment and Supplies; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The care provider will not be involved in the enrollment or assessment process. The outcomes assessor will analyze the outcomes without knowledge of allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: September 4, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)