Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)
NCT ID: NCT02910661
Last Updated: 2017-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
95 participants
OBSERVATIONAL
2017-03-28
2017-08-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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 Pittsburgh \& Seattle. Focus groups will be conducted with parents clustered by patient age (12-14 y. \& 15- 17 y.)
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Parents: Parents of patients 18-24 years old will be excluded
12 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Pittsburgh
OTHER
St. Louis Children's Hospital
OTHER
Seattle Children's Hospital
OTHER
St. Justine's Hospital
OTHER
The Hospital for Sick Children
OTHER
British Columbia Children's Hospital
OTHER
Temple University
OTHER
Université de Montréal
OTHER
Beth Foster
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Beth Foster
Associate Professor of Pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bethany J Foster, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Annette DeVito Dabbs, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital St-Louis
St Louis, Missouri, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Seattle Children's Hospital
Seattle, Washington, United States
BC Children's Hospital
Vancouver, British Columbia, Canada
University of Toronto Hospital for Sick Children
Toronto, Ontario, 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-1764
Identifier Type: -
Identifier Source: org_study_id