Adult Liver Transplant Enhanced Care

Description

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).

Study Start Date

January 2015

Estimated Completion Date

December 2016

Interventions

  • Behavioral: Behavioral Telehealth

Specialties

  • Gastroenterology: Transplant
  • Physician Assistant: Gastroenterology

MeSH Terms

  • Behavioral Telehealth
  • Liver Transplant Recipients,

Study ID

Mount Sinai School of Medicine -- GCO 14-1876

Status

Unknown

Trial ID

NCT02320422

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

8

Sponsor

Mount Sinai School of Medicine

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Icahn School of Medicine at Mount Sinai - New York, New York 46.8 miles None None None

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