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Trial record 2 of 113 for:    TAKE-IT

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

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ClinicalTrials.gov Identifier: NCT02910661
Recruitment Status : Completed
First Posted : September 22, 2016
Last Update Posted : September 28, 2017
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
Université de Montréal
Information provided by (Responsible Party):
Beth Foster, McGill University Health Center

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.

Condition or disease Intervention/treatment
Medication Adherence Other: Focus Group

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
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: TAKE-IT TOO: Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)
Actual Study Start Date : March 28, 2017
Actual Primary Completion Date : August 6, 2017
Actual Study Completion Date : August 6, 2017

Resource links provided by the National Library of Medicine


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.
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 Pittsburgh & Seattle. Focus groups will be conducted with parents clustered by patient age (12-14 y. & 15- 17 y.)
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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910661


Locations
United States, Missouri
Children's Hospital St-Louis
Saint 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
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2W 1T7
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
Université de Montréal
Investigators
Principal Investigator: Bethany J Foster, MD, MSCE McGill University Health Center
Principal Investigator: Annette DeVito Dabbs, PhD University of Pittsburgh

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
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
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 Beth Foster, McGill University Health Center:
Kidney Transplantation