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

Medication Adherence Clinical Trial

— TAKE-IT TOO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910661
• Other study ID #: 2017-1764
• Status: Completed
• Phase: N/A
• First received: September 19, 2016
• Last updated: September 26, 2017
• Start date: March 28, 2017
• Est. completion date: August 6, 2017

Study information

• Verified date: September 2017
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 6, 2017
• Est. primary completion date: August 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Other:
• Focus 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.

Locations

Country	Name	City	State
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	University of Toronto Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Columbia
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Children's Hospital St-Louis	Saint Louis	Missouri
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (9)

Lead Sponsor	Collaborator
Beth Foster	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, Université de Montréal, University of Pittsburgh

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stakeholders' needs and preferences	needs and preferences of young kidney transplant recipients, their parents, and HCP regarding electronic monitoring and adherence interventions	90 minutes