Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)

Completed

• Conditions: Medication Adherence

• Registration Number: NCT02910661
• Lead Sponsor: Beth Foster

Brief Summary

The overall goal of the Teen Adherence in KidnEy transplant Improving Tracking TO Optimize Outcomes (TAKE-IT TOO) study is to adapt the successful TAKE-IT intervention, aimed at improving medication adherence in adolescent kidney transplant, for use in 'real world' clinical care. The specific aims of Stage 1 of this study are: (1) To understand the needs and preferences of stakeholders (kidney transplant recipients, parents, and healthcare professionals (HCP)) in order to optimize the TAKE-IT intervention for 'real world' use.

Detailed Description

TAKE-IT TOO is a prospective, 3-stage, sequential study using user-centered design techniques throughout. This entry describes Stage 1of TAKE-IT TOO. In Stage 1 we will conduct focus groups (FG) to gather data about the needs and preferences of stakeholders to inform adaptation of the Teen Adherence in Kidney transplant Effectiveness of Intervention Trial (TAKE-IT) intervention and features of a novel e-pillbox and adherence-tracking website. The protocols for Stages 2 and 3 will be submitted separately.

Study Timeline

• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-22
• Study Start: 2017-03-28
• Primary Completion: 2017-08-06
• Study Completion: 2017-08-06
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-26
• Last Update Posted: 2017-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Patients: Prevalent kidney-only transplant recipients 12-24 y, ≥3 months post-transplant.
• Parents: Parents of prevalent kidney-only transplant recipients 12-17 y (followed in a participating transplant center). Parents will be eligible to participate even if their child does not participate.
• HCP: transplant healthcare professionals (including representatives from variety of disciplines typically involved in promoting medication adherence)

Exclusion Criteria

• Patients: Individuals with significant neurocognitive disabilities limiting their ability to understand and participate in their own care. Multiorgan transplant recipients. Patient or parent unable to communicate in English or French (Montreal only)
• Parents: Parents of patients 18-24 years old will be excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stakeholders' needs and preferences	90 minutes	needs and preferences of young kidney transplant recipients, their parents, and HCP regarding electronic monitoring and adherence interventions

Trial Locations

Locations (9)

Children's Hospital St-Louis; 🇺🇸 Saint Louis, Missouri, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

BC Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

University of Toronto Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal; 🇨🇦 Montreal, Quebec, Canada

CHU Ste-Justine; 🇨🇦 Montreal, Quebec, Canada

Montreal Children's Hospital of the MUHC; 🇨🇦 Montreal, Quebec, Canada