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Phone coaching helps teen transplant patients stay on track

NCT ID NCT03691220

Disease control Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a phone-based coaching program to help teenagers who had a liver transplant take their anti-rejection medication regularly. The program used personalized calls to improve adherence, with the goal of reducing organ rejection. A total of 148 teens aged 12 to 20 who were at least 2.5 years post-transplant and had a history of poor medication adherence took part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
phone-based coaching calls
What this could lead to
If it works, this could help teen liver transplant recipients stick to their medication schedule and lower their risk of organ rejection.
What could go wrong
This is a completed study with 148 participants, so results are available but may not apply to all teens. The intervention is behavioral, so success depends on individual engagement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

148 people

The number who actually took part.

Started

Nov 2018

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 19 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The patient is ≥ 12 and \< 20 years of age at enrollment. * ≥2.5 years after last liver transplantation. * Guardian's consent, adolescent assent at enrollment. * The patient is prescribed tacrolimus. * The patient's MLVI (SD of tacrolimus) was \> 2 when calculated by the site for a period of 2 years prior to the review date Exclusion Criteria: * The patient has had transplant of an organ other than liver. * The patient is currently listed for any organ transplantation. * The patient is expected to transition to another service (e.g., adult clinic, another * hospital) during the two years of the study. * Pregnant patients. * A temporary exclusion: the patient is not medically stable or was hospitalized for \>48 consecutive hours in the past three months. * Site PI, study PI, or Medical Monitor determines that the patient should not be a candidate for the intervention due to factors that are not covered in the above criteria.

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Conditions

The condition(s) this trial relates to.

transplant rejection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Transplant

Contacts and locations

Locations

  • Benioff Children's Hospital UCSF

    San Francisco, California, 94107, United States

  • C.S.Mott Children's Hospital

    Ann Arbor, Michigan, 48109, United States

  • Children's Healthcare of Atlanta/Emory

    Atlanta, Georgia, 30322, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Lurie Children's Hospital

    Chicago, Illinois, 60611, United States

  • Mattel Children's Hospital UCLA

    Los Angeles, California, 90095, United States

  • Miami Transplant Institute

    Miami, Florida, 33136, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The Hospital For Sick Children Toronto

    Toronto, Ontario, M5G1X8, Canada

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