Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02910661
Acronym
TAKE-IT TOO
Enrollment
95
Registered
2016-09-22
Start date
2017-03-28
Completion date
2017-08-06
Last updated
2017-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Adherence

Keywords

Kidney Transplantation

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.

Interventions

OTHERFocus Group

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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stakeholders' needs and preferences90 minutesneeds and preferences of young kidney transplant recipients, their parents, and HCP regarding electronic monitoring and adherence interventions

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026