Intervention to Improve Adherence in Teen Kidney Transplant

Summary

The broad aim of the proposed study is to improve medication adherence in adolescent kidney transplant recipients. The investigators hypothesize that a multi-component intervention will improve medication adherence in the adolescent kidney transplant population. The specific aims are to determine, in a randomized clinical trial, the efficacy of a structured, multi-component intervention in improving adherence to anti-rejection medications and graft outcomes, and to identify characteristics of healthcare systems that are independently associated with adherence.

Conditions

• Kidney Transplantation
• Medication Adherence

Interventions

BEHAVIORAL

Action-focused problem-solving

* Adherence Support Team (patient, parent, Coach) * standardized education on immunosuppressive medications * identification of adherence barriers * 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient

DEVICE

Electronic pillbox monitoring, dose reminders, and feedback

* Electronic adherence monitoring with feedback of past 3 months of electronic monitoring data at 3-month intervals * text message, email, or visual cue dose reminders

Sponsors & Collaborators

• Children's Hospital of Philadelphia

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• British Columbia Children's Hospital

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• St. Justine's Hospital

  collaborator OTHER

• Temple University

  collaborator OTHER

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Principal Investigators

• Bethany J Foster, MD, MSCE · Montreal Children's Hospital of the MUHC

• Susan L Furth, MD, PhD · Children's Hospital of Philadelphia

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

11 Years

Max Age

24 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2016-06-30

Completion

2016-06-30

Countries

• United States
• Canada

Study Locations