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The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis (iPeer2Peer)

24 de octubre de 2022 actualizado por: Jennifer Stinson, The Hospital for Sick Children

The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial

The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer Program and those in the control group (no mentor).

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Arthritis is a common childhood illness that makes everyday activities hard for young people. It is a long-lasting illness that can make you feel pain, tired and emotionally upset. This can make it hard for children and teens to see friends and do the activities that they like. The goal of this project is to find out if the newly developed peer mentoring program called iPeer2Peer helps teens with arthritis take better care of their illness and feel more connected to other people with arthritis. The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer Program and those in the control group (no mentor).

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

262

Fase

  • No aplica

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.

Estudio Contacto

Ubicaciones de estudio

  • Canadá
    • Alberta
    • British Columbia
      • Vancouver, British Columbia, Canadá
        • Reclutamiento
        • BC Children's Hospital
        • Contacto:
          • Lori Tucker, MD
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá
        • Reclutamiento
        • The IWK Health Centre
        • Contacto:
          • Adam Huber, MSc, MD
    • Ontario
      • London, Ontario, Canadá, N6A 5W9
        • Aún no reclutando
        • Children's Hospital - London Health Sciences
        • Contacto:
      • Ottawa, Ontario, Canadá
        • Reclutamiento
        • Children's Hospital of Eastern Ontario (CHEO)
        • Contacto:
          • Ciaran Duffy, MSc, FRCPC
        • Contacto:
          • Karen Watanabe Duffy, MD, FRCPC
        • Sub-Investigador:
          • Paula Forgeron, MD
        • Sub-Investigador:
          • Karen Watanabe Duffy, MD, FRCPC
      • Toronto, Ontario, Canadá
        • Reclutamiento
        • The Hospital for Sick Children
        • Contacto:
          • Jennifer Stinson, CPNP, PhD
        • Sub-Investigador:
          • Sara Ahola Kohut, PhD, CPsych
        • Sub-Investigador:
          • Brian Feldman, MD, FRCPC
        • Sub-Investigador:
          • Lynn Spiegel, MD, FRCPC
        • Sub-Investigador:
          • Myla Moretti, PhD

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 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • males and females 12-18 years old
  • rheumatologist-diagnosed JIA according to ILAR criteria
  • able to speak and read English
  • access to a computer, smartphone or tablet capable of using free Skype software (note: participants who do not have adequate Internet access will be provided with portable Internet sticks)
  • willing and able to complete online measures.

Exclusion Criteria:

  • significant cognitive impairments
  • major co-morbid illnesses (medical or psychiatric conditions) likely to influence HRQL assessment
  • participating in other peer support or self-management interventions.

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

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: iPeer2Peer Mentorship
In addition to standard care, youth in the experimental group will receive the iPeer2Peer program, a peer mentorship program that will provide modeling and reinforcement of self-management by pre-screened and trained peer mentors (young adults with JIA aged 18-22 years who have learned to function successfully with their disease). Mentors will encourage participants to develop and engage in self-management skills and provide social support.
Conductual: iPeer2Peer Mentorship
10 sessions of 20-30 minute Skype calls conducted over 5-12 weeks.
Comparador activo: Control Group
The control group will receive standard care but without the iPeer2Peer program.
Otro: Active Comparator: Control Group
The control group will receive standard care but without the iPeer2Peer program.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
TRANSITION-Q (measuring change)
Periodo de tiempo: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
14-item measure of self-management skills that is both reliable (internally consistent, test-retest) and valid (face, construct and content validity)
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PedsQL Arthritis Module (measuring change)
Periodo de tiempo: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Health-related quality of life
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
PROMIS Pain Interference (measuring change)
Periodo de tiempo: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Pain
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Screen for Child Anxiety Related Disorders (measuring change)
Periodo de tiempo: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Emotional distress
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Center for Epidemiologic Studies Depression Scale Revised (measuring change)
Periodo de tiempo: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Emotional distress
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Medical Issues, Exercise, Pain and Social Support Questionnaire (measuring change)
Periodo de tiempo: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Disease knowledge
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Children's Arthritis Self-Efficacy (measuring change)
Periodo de tiempo: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Self-efficacy
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
PROMIS Pediatric Peer Relationship Scale (measuring change)
Periodo de tiempo: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Perceived social support
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
AQoL-6D, interview (measuring change)
Periodo de tiempo: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Cost utility analysis
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Health service use and costs (measuring change)
Periodo de tiempo: Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Cost utility analysis
Baseline; Immediately following interview (approximately 12 weeks after baseline); 6-months post
Mentor Behavior Scale (measuring change)
Periodo de tiempo: Post-Intervention (approximately following 12 weeks of calls)
Mentor quality
Post-Intervention (approximately following 12 weeks of calls)
PROMIS Adult Profile (measuring change)
Periodo de tiempo: At beginning of study and at end of study (approximately 3 years later)
For mentors only: mentor physical and emotional symptoms
At beginning of study and at end of study (approximately 3 years later)
PROMIS Satisfaction with Social Roles and Activities (measuring change)
Periodo de tiempo: At beginning of study and at end of study (approximately 3 years later)
For mentors only: perceived social role satisfaction
At beginning of study and at end of study (approximately 3 years later)
Chronic Disease Self-Efficacy Scale (measuring change)
Periodo de tiempo: At beginning of study and at end of study (approximately 3 years later)
For mentors only: self-efficacy
At beginning of study and at end of study (approximately 3 years later)
Mentor interaction form
Periodo de tiempo: Following completion of each mentee's calls (approximately following 12 weeks of calls)
Record of interactions with mentees
Following completion of each mentee's calls (approximately following 12 weeks of calls)

Colaboradores e Investigadores

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

Patrocinador

The Hospital for Sick Children

Colaboradores

Children's Hospital of Eastern Ontario
IWK Health Centre
Provincial Health Services Authority

Investigadores

  • Investigador principal: Jennifer N Stinson, CPNP, PhD, The Hospital for Sick Children

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 (Anticipado)

31 de mayo de 2023

Finalización del estudio (Anticipado)

30 de septiembre de 2023

Fechas de registro del estudio

Enviado por primera vez

31 de marzo de 2017

Primero enviado que cumplió con los criterios de control de calidad

11 de abril de 2017

Publicado por primera vez (Actual)

17 de abril de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de octubre de 2022

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

24 de octubre de 2022

Última verificación

1 de octubre de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1000054878

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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