Improving Medication-taking After Liver Transplant

NCT01960322 | Completed Phase 1 DMC

• 1 other identifier: GCO 13-0223
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

Brief Summary

The specific aim is to pilot-test our developed intervention manual's ability to improve patients' adherence to medications and medical outcomes (rejection rate, liver enzyme levels) in participating centers.

Conditions

Nonadherence; Tacrolimus; Pediatric Liver Transplant Recipients

Keywords

adherence; nonadherence; compliance; noncompliance; liver transplantation

Outcome Measures

Primary Outcomes (1)

• Change in Adherence

  Change in Adherence at one year compared to at baseline measured via the Standard Deviation of Tacrolimus levels obtained

  at baseline and one year

Secondary Outcomes (4)

• Change in Incidence of rejection

  at baseline and at one year

• Liver Enzyme Levels

  at baseline

• Liver Enzyme Levels

  at one year

• Feasibility

  at one year

Study Arms (1)

Telemetric

EXPERIMENTAL

Enrolled patients will be followed for 12 months during which they will receive the study telemetry intervention.

Behavioral: Telemetric

Interventions

Telemetric BEHAVIORAL

A manualized behavioral management approach focusing on avoidance and addressing barriers to adherence, delivered via telephone or internet chat applications.

Telemetric

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The patient is between 11-19 years of age at enrollment.
• Guardian's consent, child assent (in accordance with each institution's IRB policies).
• The patient is prescribed tacrolimus (either brand or generic formulation).
• The patient has been seen in the enrolling center's clinic at least once in the last two years.
• The patient's SD of tacrolimus was \> 2.0 in the year prior to enrollment, with at least 3 levels present to make this determination.
• The patient and at least one guardian speaks English or Spanish at a level that allows her / him to understand the study procedures and consent to the study.

You may not qualify if:

• The patient received a liver transplant less than 1 year prior to enrollment.
• The patient has had more than one transplant (including marrow replacement).
• The patient has had biopsy-proven rejection within the past six months.
• The patient has been diagnosed with Hepatitis C.
• The treating physician has instructed the patient not to obtain tacrolimus levels for at least one year in the past year.
• The guardian or child (in a developmentally-appropriate manner) do not understand the study procedures. This will be verified by asking both guardian and child to repeat the study procedures.
• The patient is only seen for consultation - most or all of the child's routine care is provided at another center (or in a community clinic).
• The patient is not medically stable or is hospitalized.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• University of California, Los Angeles: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• University of Pittsburgh: collaborator
• The Emmes Company, LLC: collaborator

Study Sites (3)

UCLA Mattell Children's Hospital

Los Angeles, California, 90095, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

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: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: August 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 1, 2016

Record last verified: 2016-06

Locations

US (3)