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

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.

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Key information

Conditions

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

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

BC Children's Hospital, Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focus Group

Other

Concurrently at each site, an experienced facilitator, having no direct affiliation with the clinical team, will use standardized stakeholder-specific, semi-structured scripts (designed with patient and parent collaborators) to conduct the patient, parent, and HCP focus groups. The TAKE-IT intervention will be described, and Simplemed e-pillbox shown, to all focus groups. Questions posed to the patient and parent focus groups will focus on 2 themes: the intervention and electronic monitoring. Example stakeholder-specific scripts to guide the discussions are appended. Each focus group will last ~90 min. and be audio-recorded. An observer will take field notes.

Primary outcomes

Stakeholders' needs and preferences

Time frame: 90 minutes

needs and preferences of young kidney transplant recipients, their parents, and HCP regarding electronic monitoring and adherence interventions

Sponsors and collaborators

Lead sponsor

Beth Foster

Other

Collaborators

British Columbia Children's Hospital
Seattle Children's Hospital
St. Justine's Hospital
St. Louis Children's Hospital
Temple University
The Hospital for Sick Children
University of Pittsburgh
Université de Montréal

Registry information

Official study title

TAKE-IT TOO: Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)

Acronym: TAKE-IT TOO

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Sep 22, 2016
Registry last updated: Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed