Adult Liver Transplant Enhanced Care

Completed · Not applicable

Conditions studied: Liver Transplant Recipients

In brief

The purpose of this study is to pilot-test a tailored telemetric intervention to improve adherence to medications in adults who had a liver transplant and are presently non-adherent (as measured by tacrolimus levels).

Key facts

Study ID

NCT02320422

Run by

Icahn School of Medicine at Mount Sinai

People needed

8

Starts

2015-01-01

Expected to finish

2016-08-01

Last updated by the study team

2016-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient is at least 18 years of age.
• The patient received a liver transplant at least 2 years prior to initiation of the research protocol.
• The patient is able to provide consent (i.e. is not encephalopathic or does not have significant cognitive impairment). Consent may be obtained either by phone or in person (following a script) and is documented by the researcher.
• The patient is prescribed tacrolimus (either brand or generic formulation).
• The patient is not receiving Hepatitis C treatment during the intervention (given this can affect levels of tacrolimus and adherence behaviors)
• Thee patient has been seen in the liver transplant clinic at least once in the last two years.
• The patient's MLVI value was ≥ 2, with at least 3 levels present to make this determination. Only tacrolimus levels drawn in the outpatient setting will be included in SD calculations. Tacrolimus levels in the inpatient setting (i.e. during a hospitalization) will be excluded.
• The patient speaks English or Spanish at a level that allows him/her to understand the study procedures and consent to the study.

You may not qualify if…

• The patient received a liver transplant less than 2 years prior to enrollment.
• The patient received a dual transplant (i.e. liver and kidney).
• The treating physician has instructed the patient not to obtain tacrolimus levels for at least one year in the past year.
• The patient does not understand the study procedures. This will be verified by asking the patient to repeat the study procedures.
• The patient is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion) or severe cognitive impairment.
• The patient is not medically stable or is hospitalized (temporary exclusion until stabilized).

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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