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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

iMALT Trial 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.Check my eligibility

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.See study design

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.

iMALT Trial 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.

iMALT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

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

Primary outcome measures

Incidence of Rejection

Secondary outcome measures

Incidence of Locally Determined Biopsy Proven Rejection

Mean ALT

Mean gGT

+8 more

iMALT 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaOTHER

708 Previous Clinical Trials

8,581,155 Total Patients Enrolled

Seattle Children's HospitalOTHER

301 Previous Clinical Trials

5,216,829 Total Patients Enrolled

University of MiamiOTHER

899 Previous Clinical Trials

409,584 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

Frequently Asked Questions

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

Are there vacancies available in this research program for individuals seeking treatment?

"The trial, which first appeared on November 14th 2018 and was last updated on August 2nd 2022 is actively searching for potential candidates as highlighted by clinicaltrials.gov."

Answered by AI

Are there a number of healthcare facilities conducting this research trial in the city?

"This trial is welcoming patients from the Children's Hospital of Pittsburgh in Pennsylvania, Texas Children's Hospital in Houston and Columbia University Medical Center in New york as well as 13 other medical centres."

Answered by AI

What conditions must potential participants meet to qualify for the experimental protocol?

"For this study, 156 participants aged 12-19 who have undergone transplant surgery are being sought. To be eligible for the trial, these individuals must meet further criteria such as a minimum of 2.5 years since their last liver transplantation and obtain parental consent and adolescent assent at enrollment."

Answered by AI

Is this trial available to individuals who have surpassed the age of majority?

"As indicated by the requirements listed on this trial, only individuals between ages 12 and 19 are eligible to participate."

Answered by AI

To what extent has this investigation been populated by participants?

"This study necessitates 156 participants that fulfill the predetermined requirements. These individuals can receive treatment at Children's Hospital of Pittsburgh in Pennsylvania and Texas Children's Hospital in Houston, among other possible locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Medication Adherence in Adolescents Who Had a Liver Transplant

Eyal Shemesh 2018. "Improving Medication Adherence in Adolescents Who Had a Liver Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03691220.

All > Liver Transplant