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

26 de septiembre de 2017 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

95

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Canadá
    • British Columbia
      • Vancouver, British Columbia, Canadá, V6H 3V4
        • BC Children's Hospital
    • Ontario
      • Toronto, Ontario, Canadá, M5G 1X8
        • University of Toronto Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canadá, H3T 1C4
        • CHU Ste-Justine
      • Montreal, Quebec, Canadá, H2W 1T7
        • Centre Hospitalier de l'Université de Montréal
      • Montreal, Quebec, Canadá, H4A 3J1
        • Montreal Children's Hospital of the MUHC
  • Estados Unidos
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110-1002
        • Children's Hospital St-Louis
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19140-5102
        • Temple University
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213-2536
        • University of Pittsburgh Medical Center
    • Washington
      • Seattle, Washington, Estados Unidos, 98105-3901
        • Seattle Children's Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años a 70 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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).

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Otro: 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.)
Otro: 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.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Stakeholders' needs and preferences
Periodo de tiempo: 90 minutes
needs and preferences of young kidney transplant recipients, their parents, and HCP regarding electronic monitoring and adherence interventions
90 minutes

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Beth Foster

Colaboradores

The Hospital for Sick Children
University of Pittsburgh
Seattle Children's Hospital
Temple University
St. Louis Children's Hospital
British Columbia Children's Hospital
St. Justine's Hospital
Université de Montréal

Investigadores

  • Investigador principal: Annette DeVito Dabbs, PhD, University of Pittsburgh
  • Investigador principal: Bethany J Foster, MD, MSCE, McGill University Health Centre/Research Institute of the McGill University Health Centre

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

28 de marzo de 2017

Finalización primaria (Actual)

6 de agosto de 2017

Finalización del estudio (Actual)

6 de agosto de 2017

Fechas de registro del estudio

Enviado por primera vez

19 de septiembre de 2016

Primero enviado que cumplió con los criterios de control de calidad

19 de septiembre de 2016

Publicado por primera vez (Estimar)

22 de septiembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de septiembre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

26 de septiembre de 2017

Última verificación

1 de septiembre de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 2017-1764

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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