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Interprofessional Care Models Using Videoconferencing for Patients With Inflammatory Arthritis

25 de octubre de 2016 actualizado por: Regina M. Taylor-Gjevre, University of Saskatchewan

Addressing Rural and Remote Access Disparities for Patients With Inflammatory Arthritis Through Telehealth/Videoconferencing and Innovative Inter-professional Care Models

This project will be conducted in two phases. Phase 1: RA patients will be recruited to participate in five repeated examinations occurring in one day to compare between and within specialties, ensuring reasonable equivalency of examination findings. Phase 2: RA patients living > 100 km from Saskatoon will be randomized to the intervention or control group, with both groups having three follow-up appointments in 3-month intervals. The intervention group will be evaluated by a physiotherapist supported by a rheumatologist through videoconferencing, while the control group will continue to travel to Saskatoon for follow-up care.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Part A: Validation Study This study involves inter-professional care with rural-based physical therapists and urban-based rheumatologists, it will be a valuable first step to validate comparability of the physical examination. We shall compare physical examination accuracy between and within examiner disciplines. Examiners will include the three rheumatologist study investigators and three participating physical therapists with additional training in inflammatory rheumatic diseases and experienced in musculoskeletal assessment.

Procedures: All examiners will undergo a standardized review of examination techniques and documentation prior to participating.

Comparison groups will be:

  1. Rheumatologist A. to Rheumatologist B.
  2. Physiotherapist A. to Physiotherapist B.
  3. Rheumatologist A/B to Physiotherapist C/teleconferenced Rheumatologist C. We will use web-based videoconferencing software. This desktop-based solution is currently being piloted by Telehealth Saskatchewan and is used extensively in Ontario. This technology satisfies Health Information Protection Act (HIPA) as well as the Saskatchewan privacy and security concerns. An examining room with telehealth/videoconference equipment will be available for patient distance examination for comparison group C as listed above. The rheumatologist will be in a physically separate room with viewing equipment in a mock distance evaluation. The proposed study will be conducted in cooperation with the Canadian Centre for Health and Safety in Agriculture (CCHSA) within the ≈1350 m2 National Agricultural-Industrial Hygiene Laboratory. Clinical visits will be conducted at the CCHSA.

Part B: Randomized Controlled Rheumatoid Arthritis Care Delivery Model Trial Randomization: Participating patients will be randomly allocated to two arms, either to be followed by telehealth/videoconferencing in or near their home community or to continue traveling to their Saskatoon rheumatology clinic.

Intervention: One study arm will be followed in traditional rheumatology clinic (in-person examining rheumatologist). The second study arm will be followed by telehealth/videoconferencing. Patients in the telehealth/videoconferencing arm will be examined by a rural-based physical therapist who will report exam findings during telehealth review with the urban-based rheumatologist. Follow-up visits will be every three months in both arms. All patients will complete standardized history/data-collection forms. Patients will be followed in their respective study arms for nine months, and then will be evaluated in-person in rheumatology clinic for final face-to-face disease activity evaluation.

Tipo de estudio

Intervencionista

Inscripción (Actual)

85

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.

Ubicaciones de estudio

    • Saskatchewan
      • Saskatoon, Saskatchewan, Canadá
        • University of Saskatchewan

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Part A: Patients with established rheumatologist diagnosed RA attending rheumatology clinic at Royal University Hospital, (Saskatoon) and providing informed consent, will be recruited.

Part B: As the target population for future telehealth/VC utilization will be patients living outside the urban centers, participants will be similarly selected. Inclusion criteria will be: age over 18 years, ability to provide informed consent, place of residence 100 kilometers or more outside of Saskatoon, and rheumatologist established diagnosis of rheumatoid arthritis.

Exclusion Criteria:

Exclusion criteria will include participation in the earlier validation study (Part A).

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: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Videoconference follow-up
These subjects will remain in or near their home communities for rheumatology follow-up visits. Follow-up visits will occur via telehealth/videoconferencing, with a physiotherapist present, performing the in-person assessment, supported by the rheumatologist via videoconference.
Rheumatology visits to take place video videoconference with a physiotherapist present
Sin intervención: Control
These subjects will continue to travel into Saskatoon for the rheumatology visits, as they normally would for routine follow-up visits with their rheumatologist.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change in Disease Activity Score-28 (DAS-28)
Periodo de tiempo: at 3 month intervals over nine months
at 3 month intervals over nine months

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Change in European Quality of Life - 5 Dimensions(EQ-5D)
Periodo de tiempo: at 3 month intervals over nine months
at 3 month intervals over nine months
Change in Epworth Sleepiness Scale
Periodo de tiempo: at 3 month intervals over nine months
at 3 month intervals over nine months
Change in Healthcare Use
Periodo de tiempo: at 3 month intervals over nine months
at 3 month intervals over nine months
Change in Modified Health Assessment Questionnaire (MHAQ)
Periodo de tiempo: at 3 month intervals over nine months
at 3 month intervals over nine months
Change in Work Productivity and Activity Impairment Questionnaire (WPAI)
Periodo de tiempo: at 3 month intervals over nine months
at 3 month intervals over nine months
Change in International Physical Activity Questionnaire (IPAQ)
Periodo de tiempo: at 3 month intervals over nine months
at 3 month intervals over nine months
Change in Rheumatoid Arthritis Disease Activity Index (RADAI)
Periodo de tiempo: at 3 month intervals over nine months
at 3 month intervals over nine months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Regina Taylor-Gjevre, MD, Univsersity of Saskatchewan

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

1 de junio de 2014

Finalización primaria (Actual)

1 de agosto de 2016

Finalización del estudio (Actual)

1 de agosto de 2016

Fechas de registro del estudio

Enviado por primera vez

8 de diciembre de 2014

Primero enviado que cumplió con los criterios de control de calidad

19 de febrero de 2015

Publicado por primera vez (Estimar)

26 de febrero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

26 de octubre de 2016

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

25 de octubre de 2016

Última verificación

1 de octubre de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 14-176

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

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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