Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)
TAKE-IT TOO
TAKE-IT TOO: Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)
1 other identifier
observational
95
2 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2017
Shorter than P25 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2016
CompletedFirst Posted
Study publicly available on registry
September 22, 2016
CompletedStudy Start
First participant enrolled
March 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 6, 2017
CompletedSeptember 28, 2017
September 1, 2017
4 months
September 19, 2016
September 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stakeholders' needs and preferences
needs and preferences of young kidney transplant recipients, their parents, and HCP regarding electronic monitoring and adherence interventions
90 minutes
Study Arms (3)
Patients
Focus groups (n=6-8/group) will be conducted at 4 sites selected to maximize racial diversity and to ensure availability of adequate numbers in each age group (Montreal (incl. the McGill University Health Centre (MUHC), Centre Hospitalier Universitaire-Ste. Justine \& CHUM ), Pittsburgh, Seattle, and St. Louis). Separate focus groups will be conducted with patients clustered by patient age to maximize homogeneity in developmental stage. Purposive sampling will be employed to ensure that each focus group includes patients with combinations of characteristics that are likely to account for variation in perspectives, including the major racial and ethnic groups, both sexes, time since transplant, and level of adherence.
Parents
Focus groups (n=6-8/group) will be conducted at Pittsburgh \& Seattle. Focus groups will be conducted with parents clustered by patient age (12-14 y. \& 15- 17 y.)
Healthcare professionals
One focus group of healthcare professionals (HCP) representing the variety of multidisciplinary transplant team members at each center will be convened. We will aim for 4-8 HCP per group; however, the number will be dictated by the composition and size of the transplant team at each site. We expect variability in the organization of care across the 7 sites, which represent 2 countries and small to large program sizes; including all sites will capture this variability.
Interventions
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.
Eligibility Criteria
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).
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Fosterlead
- University of Pittsburghcollaborator
- St. Louis Children's Hospitalcollaborator
- Seattle Children's Hospitalcollaborator
- St. Justine's Hospitalcollaborator
- The Hospital for Sick Childrencollaborator
- British Columbia Children's Hospitalcollaborator
- Temple Universitycollaborator
- Université de Montréalcollaborator
Study Sites (9)
Children's Hospital St-Louis
St Louis, Missouri, 63110-1002, United States
Temple University
Philadelphia, Pennsylvania, 19140-5102, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213-2536, United States
Seattle Children's Hospital
Seattle, Washington, 98105-3901, United States
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
University of Toronto Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2W 1T7, Canada
CHU Ste-Justine
Montreal, Quebec, H3T 1C4, Canada
Montreal Children's Hospital of the MUHC
Montreal, Quebec, H4A 3J1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bethany J Foster, MD, MSCE
McGill University Health Centre/Research Institute of the McGill University Health Centre
- PRINCIPAL INVESTIGATOR
Annette DeVito Dabbs, PhD
University of Pittsburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
September 19, 2016
First Posted
September 22, 2016
Study Start
March 28, 2017
Primary Completion
August 6, 2017
Study Completion
August 6, 2017
Last Updated
September 28, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will share
Data generated will be available for use to other investigators in the research community. Data may be used for hypothesis testing, and to generate preliminary data in support of future research projects. A Data Sharing Committee, composed site investigators will review requests submitted for use of the data. If the request is approved, the appropriate data analysis will be performed and the results sent to the requesting investigator. Alternatively, depending on the request, it may be more appropriate to provide the requesting investigator with certain segments of the data. If this is the case, a file of the requested data (de-identified) will be provided to the investigator.