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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2016 by McGill University Health Center
Sponsor:
Collaborators:
University of Pittsburgh
St. Louis Children's Hospital
Seattle Children's Hospital
St. Justine's Hospital
The Hospital for Sick Children
British Columbia Children's Hospital
Temple University
Information provided by (Responsible Party):
Beth Foster, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT02910661
First received: September 19, 2016
Last updated: NA
Last verified: September 2016
History: No changes posted
  Purpose
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.

Condition Intervention
Medication Adherence
Other: Focus Group

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: TAKE-IT TOO: Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Stakeholders' needs and preferences [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    needs and preferences of young kidney transplant recipients, their parents, and HCP regarding electronic monitoring and adherence interventions


Estimated Enrollment: 128
Study Start Date: September 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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), 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.
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.
Parents
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), Pittsburgh, Seattle, and St. Louis). Focus groups will be conducted with parents clustered by patient age to maximize homogeneity in developmental stage.
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.
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.
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.

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

Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Representative groups of stakeholders (patients, parents and HCP) will be recruited from 7 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 4 in Canada (MUHC, Ste-Justine Hospital (HSJ), Vancouver's British Columbia Children's Hospital, and Toronto's Hospital for Sick Children).
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02910661

Contacts
Contact: Bethany J Foster, MD, MSCE 514-412-4400 ext 23323 bethany.foster@mcgill.ca
Contact: Lovemine Jeannot, MSc 514-412-4400 ext 22712 lovemine.jeannot@muhc.mcgill.ca

Locations
United States, Missouri
Children's Hospital St-Louis
St.Louis, Missouri, United States, 63110-1002
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140-5102
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213-2536
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105-3901
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Ontario
University of Toronto Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
CHU Ste-Justine
Montreal, Quebec, Canada, H3T 1C4
Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
Beth Foster
University of Pittsburgh
St. Louis Children's Hospital
Seattle Children's Hospital
St. Justine's Hospital
The Hospital for Sick Children
British Columbia Children's Hospital
Temple University
Investigators
Principal Investigator: Bethany J Foster, MD, MSCE McGill University Health Center
Principal Investigator: Annette DeVito Dabbs, PhD University of Pittsburgh
  More Information

Responsible Party: Beth Foster, Associate Professor of Pediatrics, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02910661     History of Changes
Other Study ID Numbers: 2017-1764 
Study First Received: September 19, 2016
Last Updated: September 19, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: 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.

Keywords provided by McGill University Health Center:
Kidney Transplantation

ClinicalTrials.gov processed this record on September 26, 2016