- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02910661
Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1) (TAKE-IT TOO)
September 26, 2017 updated by: Beth Foster
TAKE-IT TOO: Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
95
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6H 3V4
- BC Children's Hospital
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- University of Toronto Hospital for Sick Children
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1C4
- CHU Ste-Justine
-
Montreal, Quebec, Canada, H2W 1T7
- Centre Hospitalier de l'Université de Montréal
-
Montreal, Quebec, Canada, H4A 3J1
- Montreal Children's Hospital of the MUHC
-
-
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110-1002
- Children's Hospital St-Louis
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19140-5102
- Temple University
-
Pittsburgh, Pennsylvania, United States, 15213-2536
- University of Pittsburgh Medical Center
-
-
Washington
-
Seattle, Washington, United States, 98105-3901
- Seattle Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.)
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stakeholders' needs and preferences
Time Frame: 90 minutes
|
needs and preferences of young kidney transplant recipients, their parents, and HCP regarding electronic monitoring and adherence interventions
|
90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Annette DeVito Dabbs, PhD, University of Pittsburgh
- Principal Investigator: Bethany J Foster, MD, MSCE, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2017
Primary Completion (Actual)
August 6, 2017
Study Completion (Actual)
August 6, 2017
Study Registration Dates
First Submitted
September 19, 2016
First Submitted That Met QC Criteria
September 19, 2016
First Posted (Estimate)
September 22, 2016
Study Record Updates
Last Update Posted (Actual)
September 28, 2017
Last Update Submitted That Met QC Criteria
September 26, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2017-1764
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Medication Adherence
-
NYU Langone HealthRobert Wood Johnson Foundation; New York City Health and Hospitals CorporationCompletedMedication Adherence | Medication ErrorsUnited States
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingMedication Adherence | Medication ComplianceUnited States
-
Vanderbilt University Medical CenterCompletedAdherence, Medication | Nonadherence, MedicationUnited States
-
Universidad Autonoma de Baja CaliforniaCompletedMedication Adherence | Medication ComplianceMexico
-
Universiti Putra MalaysiaCompletedMedication Adherence | Adherence, TreatmentPakistan
-
University Hospital, Basel, SwitzerlandUniversity of BaselCompletedPolymedication-Check With Insight in Patients' Medication Organisation and Comprehension of GenericsMedication Adherence | Medication Therapy ManagementSwitzerland
-
Cliniques universitaires Saint-Luc- Université...RecruitingAdherence, MedicationBelgium
-
Northwell HealthNational Institute on Aging (NIA)RecruitingMedication AdherenceUnited States
-
Swedish Medical CenterNational Institute of Mental Health (NIMH); University of Washington; University...Recruiting
-
Northwell HealthToronto Dominion BankCompletedMedication AdherenceUnited States
Clinical Trials on Focus Group
-
Queen's University, BelfastCompletedAge Related Macular DegenerationUnited Kingdom
-
M.D. Anderson Cancer CenterCompletedPediatric CancersUnited States
-
Stanford UniversityNational Institute of Mental Health (NIMH)Completed
-
Teesside UniversitySouth Tees Hospitals NHS Foundation TrustNot yet recruitingOveractive Bladder | Urinary Incontinence | Benign Prostatic Hyperplasia | Urinary Tract Infections | Urinary Retention | Underactive Bladder
-
University of Kansas Medical CenterEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedPregnancy RelatedUnited States
-
University of North Carolina, Chapel HillCompletedAcquired Immunodeficiency Syndrome
-
Sunnybrook Health Sciences CentreWithdrawnFocus of Study is on Dentist's Attitudes Toward BP MeasuresCanada
-
Oregon Health and Science UniversityRecruitingAttention Deficit/Hyperactivity Disorder | Irritable Mood | Emotional DysfunctionUnited States
-
University of Colorado, DenverRecruiting
-
Universidad Miguel Hernandez de ElcheUniversidad Catolica Santiago de Guayaquil; Hospital General del Norte de Guayaquil...CompletedOccupational Stress | Stress, PhysiologicalEcuador