- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00927706
Experimental Control Investigation of the Impact of Assistive Technology on the User-caregiver Dyad: a Multi-site Trial (ATUTI)
Experimental Control Investigation of the Impact of an Assistive Technology Updating and Tune up Intervention on the User-caregiver Dyad: a Multi-site Trial
The purpose of this study is to determine the effectiveness of an assistive technology updating and tune up intervention on users and their caregivers. This intervention includes 4 components:
- an in-residence assessment of the mobility preferences of the older person and his/her caregiver
- a detailed review of forms of assistance, technological and human, that are currently being used
- recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy
- therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver. The intervention is provided to the immediate treatment following the administration of baseline measures and the delayed intervention group six weeks later, after an additional baseline measurement. The treatment is six weeks long and the follow-up is 26 weeks.
Hypothesis 1: For community-dwelling older people, an intervention that increases the appropriateness of existing or new assistive technology(AT) for mobility or self-care will alter established patterns of human assistance, such that caregiver burden is reduced or eliminated.
Hypothesis 2: At the same time, AT users will report less difficulty in mobility or self-care, as well as enhanced subjective well-being, and satisfaction with their modified personal assistance strategy.
Hypothesis 3: Following the AT intervention, caregivers will report reduced physical and/or psychological demands and increased satisfaction with their caregiving-related activities compared with
- the pre-intervention period
- caregivers in a delayed intervention control group. Hypothesis 4: Decreased physical and/or psychological demands on helpers will be associated with increases in device users' satisfaction with their personal assistance strategies.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
-
-
British Columbia
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Vancovuer, British Columbia, Canadá, V6B 5K3
- Simon Fraser University
-
-
Quebec
-
Montreal, Quebec, Canadá
- Centre de santé et des services sociaux de Bordeaux-Cartierville--St-Laurent
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Montreal, Quebec, Canadá
- the Centre de santé et des services sociaux Cavendish
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Montreal, Quebec, Canadá
- the Centre de santé et des services sociaux de Laval
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Users: Aged 65 years and over
- Have moderate to severe disability that limits their ability to move from place to place independently and/or to perform self-care activities.
- Living at home
- Receiving 2 or more hour per week of assistance with mobility and/or self-care activities from a non-professional, caregiver who is also willing to take part in the study.
- Those caregivers will be adults aged 18 years and over.
Exclusion Criteria:
- Assistive technology users will be excluded if they have severe aphasia, are currently on a community occupational therapist caseload, or are unable to communicate in English or French.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Immediate intervention
Subjects and their caregivers randomized to this arm receive the intervention immediately after baseline data is collected.
|
This intervention includes 4 components: 1) an in-residence assessment of the mobility preferences of the older person and his/her caregiver; 2) a detailed review of forms of assistance, technological and human, that are currently being used; 3) recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy; and 4) therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver.
|
Experimental: Delayed Intervention
Subjects and their caregivers who are randomized to this group will receive the intervention after baseline measurements are administered twice (6 weeks apart).
|
This intervention includes 4 components: 1) an in-residence assessment of the mobility preferences of the older person and his/her caregiver; 2) a detailed review of forms of assistance, technological and human, that are currently being used; 3) recommendations by an occupational therapist for possible changes in the older person's mobility assistive technology or assistance strategy; and 4) therapist negotiation of an mobility assistive technology updating and tune-up intervention plan with the individual and his or her caregiver.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Assessment of Life Habits
Prazo: baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
|
baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
|
Caregivers: Caregiver Assistive Technology Outcome Measure
Prazo: base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later
|
base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Individually Prioritized Problem Assessment
Prazo: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
|
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
|
Functional Autonomy Measurement System
Prazo: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
|
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
|
Psychological Impact of Assistive Devices Scale
Prazo: Imediately after intervention. 16 weeks later
|
Imediately after intervention. 16 weeks later
|
Satisfaction with Personal Assistance Strategy
Prazo: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
|
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Louise Demers, PhD, Université de Montréal
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
- CRIUM-8317
- NIDRR: H133A060062
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