Adult Liver Transplant Enhanced Care

NCT02320422 | Completed DMC

• 1 other identifier: GCO 14-1876
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Liver Transplant Recipients

Keywords

liver transplant; medication adherence; intervention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Incidence of biopsy-proven rejection

  up to 1 year

• ALT

  up to 1 year

• Incidence of hospitalizations

  up to 1 year

Study Arms (1)

Behavioral Telehealth

EXPERIMENTAL

Behavioral: Behavioral Telehealth

Interventions

Behavioral Telehealth BEHAVIORAL

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

Behavioral Telehealth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Eyal Shemesh, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: December 19, 2014
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 9, 2016

Record last verified: 2016-12

Locations

US (1)