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Adult Liver Transplant Enhanced Care (ALTER)

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ClinicalTrials.gov Identifier: NCT02320422
Recruitment Status : Completed
First Posted : December 19, 2014
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Liver Transplant Recipients Behavioral: Behavioral Telehealth Not Applicable

Detailed Description:
Adult patients who received a liver transplant and for whom there are at least 3 tacrolimus blood levels within the last year are eligible for the study. Patients will be recruited from amongst the roster of liver transplant recipients treated at the Recanati-Miller Transplant Institute at Mount Sinai. The intervention will be pilot-tested on up to 15 non-adherent patients. Patients will be identified using an innovative biomarker for non-adherence-by calculating the degree of fluctuation between individual medication blood levels. The telemetric intervention (administered via telephone, or interactive video chat applications such as FaceTime ® or Skype ®) will enable the intervention team (IT) to address non-adherence from a remote location, using a structured, tailored approach that accommodates specific patient needs. The approach includes a focus on psychological avoidance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Intervention to Improve Adherence to Medications in Adults With Liver Transplants
Study Start Date : January 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioral Telehealth Behavioral: Behavioral Telehealth
The telemetric intervention (administered via telephone, or interactive video chat applications such as FaceTime ® or Skype ®) will enable the intervention team (IT) to address non-adherence from a remote location, using a structured, tailored approach




Primary Outcome Measures :
  1. Medication Level Variability Index (MLVI) [ Time Frame: up to 1 year ]
    The degree of fluctuation of tacrolimus blood levels (calculated as the standard deviation, SD, of tacrolimus).


Secondary Outcome Measures :
  1. Incidence of biopsy-proven rejection [ Time Frame: up to 1 year ]
    The number of incidences of liver transplant rejection (as proven by biopsy).

  2. ALT [ Time Frame: up to 1 year ]
    Liver enzyme levels - mean/maximum levels of ALT

  3. Incidence of hospitalizations [ Time Frame: up to 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320422


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Eyal Shemesh, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02320422     History of Changes
Other Study ID Numbers: GCO 14-1876
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016

Keywords provided by Icahn School of Medicine at Mount Sinai:
liver transplant
medication adherence
intervention