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Behavioral Intervention

Telemetric Intervention for Liver Transplant Patients (iMALT Trial)

N/A
Waitlist Available
Led By Eyal Shemesh, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient is ≥ 12 and < 20 years of age at enrollment
≥2.5 years after last liver transplantation
Must not have
The patient has had transplant of an organ other than liver
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to help people who have had a liver transplant take their medicine properly, in the hopes of reducing the number of transplants that are rejected.

Who is the study for?
This trial is for adolescents aged 12-19 who had a liver transplant at least 2.5 years ago and are struggling with taking their medication regularly, as shown by high MLVI scores. They must be on tacrolimus and have guardian consent to participate. It's not for those who've had other organ transplants, might need another one soon, will change medical services in the next two years, are pregnant or were recently hospitalized.
What is being tested?
The study is testing a special telemetric program designed to help these teens take their medicine more consistently to prevent rejection of their transplanted liver. The effectiveness of this personalized tech-based intervention is measured against the variability in their medication levels over time.
What are the potential side effects?
Since this trial focuses on improving medication adherence through technology rather than new medications, there aren't direct side effects from drugs being tested; however, participants may experience stress or anxiety related to consistent monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 19 years old.
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It has been over 2.5 years since my last liver transplant.
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I am currently taking tacrolimus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had an organ transplant, but it was not the liver.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Rejection
Secondary study objectives
Mean ALT
Mean gGT
Mean maximal ALT
+4 more

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Telemetric Intervention ArmExperimental Treatment1 Intervention
Adolescent with MLVI\>2 to receive the telemetric intervention.
Group II: Standard of Care ArmActive Control1 Intervention
Adolescent with MLVI\>2 to receive standard of care.

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaOTHER
729 Previous Clinical Trials
8,470,155 Total Patients Enrolled
Seattle Children's HospitalOTHER
310 Previous Clinical Trials
5,230,932 Total Patients Enrolled
University of MiamiOTHER
947 Previous Clinical Trials
427,557 Total Patients Enrolled

Media Library

Telemetric Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03691220 — N/A
Transplant Research Study Groups: Telemetric Intervention Arm, Standard of Care Arm
Transplant Clinical Trial 2023: Telemetric Intervention Highlights & Side Effects. Trial Name: NCT03691220 — N/A
Telemetric Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03691220 — N/A
~0 spots leftby Dec 2024
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