Icahn School of Medicine at Mount Sinai
New York, 10029, United States
NCT Number: NCT02320422
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
New York, 10029, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: up to 1 year
The degree of fluctuation of tacrolimus blood levels (calculated as the standard deviation, SD, of tacrolimus).
Time frame: up to 1 year
The number of incidences of liver transplant rejection (as proven by biopsy).
Time frame: up to 1 year
Liver enzyme levels - mean/maximum levels of ALT
Time frame: up to 1 year
Icahn School of Medicine at Mount Sinai
Other
An Intervention to Improve Adherence to Medications in Adults With Liver Transplants
Acronym: ALTER
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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