Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2015-01-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Behavioral Telehealth
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Principal Investigators
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Eyal Shemesh, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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Other Identifiers
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GCO 14-1876
Identifier Type: -
Identifier Source: org_study_id