- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02371915
Interprofessional Care Models Using Videoconferencing for Patients With Inflammatory Arthritis
Addressing Rural and Remote Access Disparities for Patients With Inflammatory Arthritis Through Telehealth/Videoconferencing and Innovative Inter-professional Care Models
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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:
- Rheumatologist A. to Rheumatologist B.
- Physiotherapist A. to Physiotherapist B.
- 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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canadá
- University of Saskatchewan
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
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
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Change in Disease Activity Score-28 (DAS-28)
Prazo: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Change in European Quality of Life - 5 Dimensions(EQ-5D)
Prazo: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Change in Epworth Sleepiness Scale
Prazo: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Change in Healthcare Use
Prazo: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Change in Modified Health Assessment Questionnaire (MHAQ)
Prazo: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Change in Work Productivity and Activity Impairment Questionnaire (WPAI)
Prazo: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Change in International Physical Activity Questionnaire (IPAQ)
Prazo: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Change in Rheumatoid Arthritis Disease Activity Index (RADAI)
Prazo: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Regina Taylor-Gjevre, MD, Univsersity of Saskatchewan
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 14-176
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Videoconference follow-up
-
University of WashingtonNational Institute on Aging (NIA); Kaiser PermanenteConcluídoSintomas Comportamentais | Demência | Doença de Alzheimer | Sobrecarga do cuidadorEstados Unidos
-
Region SkaneAtivo, não recrutandoOsteoartrite do quadrilSuécia
-
Institut Claudius RegaudConcluído
-
University of AarhusConcluído
-
University of California, San FranciscoAgency for Healthcare Research and Quality (AHRQ)ConcluídoDor, Pós-operatório | Complicação, Pós-operatórioEstados Unidos
-
Shannon E. Sauer-ZavalaNational Institute of Mental Health (NIMH)Ativo, não recrutandoTranstorno obsessivo-compulsivo | Transtornos de ansiedade | Transtorno de Estresse Pós-TraumáticoEstados Unidos
-
University of ChicagoUniversity of California, Los Angeles; Oak Foundation; UBS Optimus Foundation; Trickle... e outros colaboradoresConcluídoAbuso infantil | Maltrato infantilBurkina Faso
-
Shannon E. Sauer-ZavalaConcluídoDesordem depressiva | Transtorno obsessivo-compulsivo | Transtornos de ansiedade | Transtorno de Estresse Pós-TraumáticoEstados Unidos
-
air up GmbHCitruslabsRecrutamento
-
University of MichiganNational Institute on Drug Abuse (NIDA); Brown University; Pennington Biomedical... e outros colaboradoresRecrutamento