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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

THRiVE Trial 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.Check my eligibility

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.See study design

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.

THRiVE Trial 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.

THRiVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Surgery for Creation of Hemodialysis Arteriovenous Access (Effectiveness outcome)

Secondary outcome measures

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 outcome measures

Creation of Arteriovenous Vascular Access Without Subsequent Need for Hemodialysis

THRiVE 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,881,923 Total Patients Enrolled

University of North Carolina, Chapel HillOTHER

1,508 Previous Clinical Trials

4,190,682 Total Patients Enrolled

Johns Hopkins UniversityOTHER

2,266 Previous Clinical Trials

14,837,137 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to participate in this trial currently available?

"Unfortunately, according to the information on clinicaltrials.gov this investigation is no longer recruiting participants as it was last updated August 23rd 2023. Nonetheless, 539 other trials are actively looking for patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transforming Hemodialysis-Related Vascular Access Education

Laura Dember, MD 2023. "Transforming Hemodialysis-Related Vascular Access Education". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05997875.