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New York, New York 10029


Purpose:

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 summary:

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.


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).


NCT ID:

NCT02320422


Primary Contact:

Principal Investigator
Eyal Shemesh, MD
Icahn School of Medicine at Mount Sinai


Backup Contact:

N/A


Location Contact:

New York, New York 10029
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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