Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy

Hypertension Clinical Trial

— iPREP RRT  

Official title:

Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06397456
• Other study ID #: IRB20-1663
• Secondary ID: R01DK124597
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Participants will be randomized to the iPREP RRT intervention versus enhanced usual care.

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 CKD self-management and 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 CKD patients' initiation and maintenance of CKD self-management and RRT planning, compared to enhanced usual care (attention controls).

Our ultimate goal is to improve knowledge and outcomes for African American patients with advanced CKD through the iPREP RRT. To accomplish this goal, we will 1) 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 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 CKD patients' initiation and maintenance of CKD self-management and RRT planning, compared to enhanced usual care. To that end, we will conduct a one-site randomized controlled trial, where patients 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 185
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients over the age of 18 and under 70; 2. Admitted to the University of Chicago inpatient general medicine service; 3. Likely hospital stay greater than 48 hours; 4. 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); and 5. 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 hours, current admission in ICU

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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	Baseline, 1 day Post Brief Intervention, Week 4, Week 8, Week 12, Week 16
Secondary	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.	Baseline, 1 day Post-Brief Intervention, Week 4