Adult Liver Transplant Enhanced Care

Liver Transplant Recipients Clinical Trial

— ALTER  

Official title:

An Intervention to Improve Adherence to Medications in Adults With Liver Transplants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320422
• Other study ID #: GCO 14-1876
• Status: Completed
• Phase: N/A
• First received: December 16, 2014
• Last updated: December 8, 2016
• Start date: January 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Transplant Recipients

Intervention

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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Level Variability Index (MLVI)	The degree of fluctuation of tacrolimus blood levels (calculated as the standard deviation, SD, of tacrolimus).	up to 1 year	No
Secondary	Incidence of biopsy-proven rejection	The number of incidences of liver transplant rejection (as proven by biopsy).	up to 1 year	No
Secondary	ALT	Liver enzyme levels - mean/maximum levels of ALT	up to 1 year	No
Secondary	Incidence of hospitalizations		up to 1 year	No