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Behavioral Intervention

Educational Strategies for Advanced Kidney Disease (THRiVE Trial)

N/A
Recruiting
Led By Laura M Dember, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Documentation in the medical record or confirmation from the treating nephrologist of a patient-nephrologist discussion about hemodialysis
Must not have
Does not speak either English or Spanish
Planning for peritoneal dialysis, preemptive transplant, or conservative management of kidney failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests 3 ways to help people with advanced kidney disease prepare for hemodialysis vascular access placement. Education, Education-Plus, and Usual Care approaches are compared to understand best practice.

Who is the study for?
This trial is for adults over 18 with advanced chronic kidney disease who've discussed hemodialysis with their doctor, visited a nephrologist in the last 18 months, and have specific lab results indicating severe kidney function decline. It's not for those already planning different kidney failure treatments or who can't use the educational materials due to cognitive or visual impairments.
What is being tested?
The study compares three ways of teaching about vascular access for hemodialysis: 'Education' uses a video and brochure; 'Education-Plus' adds motivational interviews via telehealth; 'Usual Care' is what patients normally get from doctors. Participants will be randomly assigned to one method and share feedback through questionnaires and possible interviews.
What are the potential side effects?
Since this trial focuses on educational methods rather than medical treatments, there are no direct side effects like you'd expect from medication. However, participants may experience stress or anxiety related to learning about their condition and treatment options.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have discussed starting hemodialysis with my kidney doctor.
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My kidney function is severely reduced or my risk of kidney failure is high.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not speak English or Spanish.
Select...
I am planning treatment for kidney failure that doesn't involve regular dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Surgery for Creation of Hemodialysis Arteriovenous Access (Effectiveness outcome)
Secondary study objectives
Acceptability Intervention Measure - quantitative acceptability assessment (Implementation outcome)
Acceptability of Intervention Content, Delivery, and Accessibility - qualitative acceptability assessment (Implementation outcome)
Brochure Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)
+23 more
Other study objectives
Creation of Arteriovenous Vascular Access Without Subsequent Need for Hemodialysis

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment2 Interventions
Group II: Education-PlusExperimental Treatment4 Interventions
Group III: EducationExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Motivational Interviewing
2020
Completed Phase 3
~8850
Educational Materials
2013
N/A
~16390
Usual Care
1990
Completed Phase 4
~7700

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityOTHER
2,328 Previous Clinical Trials
14,874,265 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,081 Previous Clinical Trials
42,724,460 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,557 Previous Clinical Trials
4,298,692 Total Patients Enrolled

Media Library

Educational Materials (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05997875 — N/A
Chronic Kidney Disease Research Study Groups: Education-Plus, Usual Care, Education
Chronic Kidney Disease Clinical Trial 2023: Educational Materials Highlights & Side Effects. Trial Name: NCT05997875 — N/A
Educational Materials (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05997875 — N/A
~240 spots leftby Sep 2027
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