Clinical trial NCT02910661: Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)
Official title: TAKE-IT TOO: Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medication Adherence
Keywords: Kidney Transplantation
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: St. Louis Children's Hospital
name: Seattle Children's Hospital
name: St. Justine's Hospital
name: The Hospital for Sick Children
name: British Columbia Children's Hospital
name: Temple University
name: Université de Montréal
First posted: 2016-09-22
Enrollment: 95
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Representative groups of stakeholders (patients, parents and HCP) will be recruited from renal transplant centers representing two healthcare systems and a variety of program sizes: 3 in the United States (UPMC \[which includes both adult and pediatric programs\], Seattle Children's Hospital and St. Louis Children's Hospital), and 5 in Canada (MUHC, Ste-Justine Hospital (HSJ), Centre Hospitalier de l'Université de Montréal (CHUM), Vancouver's British Columbia Children's Hospital, and Toronto's Hospital for Sick Children).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stakeholders' needs and preferences
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Children's Hospital St-Louis
state: Missouri
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: University of Toronto Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Montreal
country: Canada
facility: CHU Ste-Justine
state: Quebec
city: Montreal
country: Canada
facility: Montreal Children's Hospital of the MUHC
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Bethany J Foster, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Annette DeVito Dabbs, PhD
role: PRINCIPAL_INVESTIGATOR
References: