- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01960582
Evaluation of Housing Adaptations and Mobility Devices (FORMASEvid)
Housing Adaptations and Mobility Devices - Evaluation of a New Practice Strategy
The rationale underlying this project is the fact that HA is a very common compensatory interven¬tion within municipality health care, undertaken to support an independent living in the own home. In addition, MD are frequently prescribed and used among HA clients in order to compensate for declined body functions. In spite of this, knowledge of their effects for the individual and the society is still scarce. In particular, systematic, evidence-based strategies based on clear-cut conceptual definitions and descriptions of procedures are lacking. Such strategies are crucial in order to evaluate the effects of HA and MD. In addition, longterm cost-effectiveness evaluations are crucial for policy implementation.
The overarching aim is to investigate outcomes of HA on aspects of home and health for sub-groups of persons with disabilities.
The specific aims are to:
- Investigate the effects of HA on home and health related outcomes, i.e. usability, fear of falling, activity/participation and health-related quality of life for different subgroups of persons, e.g. MD users and non MD-users
- Investigate the use of a new practice strategy for HA on home and health related outcomes for subgroups of persons with disabilities in terms of differences between municipalities
- Investigate societal level outcomes of HA and MD, i.e. costs and quality adjusted life years
- Gain a deeper understanding of the processes behind changes in outcomes We hypothesise that using a structure strategy for housing adaptation and mobility devices case management in ordinary practice in Swedish municipalities increase activity, participation, the usability of the home, and reduces societal costs.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
The ultimate goal of the project is to improve the housing situation of older people and people with disabilities, by determining the long term effects of housing adaptations (HA) for clients and society, and transferring this knowledge into guidelines for practitioners in the housing and building planning sector.
Specific research questions are:
RQ1. What are the long-term effects of HA for clients (individual goals achievement, activity, participation, health-related quality of life, usability, falls, functional capacity and use of mobility devices (MD), mortality, health care and social services consumption, and relocation)? RQ2. What are the long-term effects of HA for society (costs and cost- effectiveness)? RQ3. What are the barriers and facilitators to knowledge transfer in the area of HA? RQ4. How can evidence based knowledge be transferred into practical guidelines for housing and building planning in Sweden?
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
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Lund, Suécia, 221 00
- Department of Health Sciences, Lund University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Persons receiving housing adaptation
- Above 20 years
Exclusion Criteria:
- Persons with language deficits and/or cognitive decline
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: New Practice Strategy
Structured strategy for assessment and evaluation before and after intervention
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Application of a structured case management strategy on housing adaptation cases
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Sem intervenção: Ordinary practice
Ordinary practice, not structured
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
ADL Staircase
Prazo: Differences in changes between intervention and control sites at baseline and 3, 6,12, 24 and 36 months after
|
The ADL Staircase measures dependence on other persons in daily activities.
Combined interview and observation
|
Differences in changes between intervention and control sites at baseline and 3, 6,12, 24 and 36 months after
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Falls Efficacy Scale- FES-I
Prazo: Differences in changes between intervention and control sites at baseline and 3, 6, 12, 24 and 36 months after
|
FES-I measures perceived fear of falling
|
Differences in changes between intervention and control sites at baseline and 3, 6, 12, 24 and 36 months after
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Usability of the home, UIMH
Prazo: Differences in changes between intervention and control sites between baseline and 3, 6,12,24 and 36 months after
|
Self-rated assessment measuring the extent to which the person can perform Daily activities in the housing
|
Differences in changes between intervention and control sites between baseline and 3, 6,12,24 and 36 months after
|
|
Costs of housing adaptations
Prazo: 3,6, 12, 24 and 36 months after, for the whole sample
|
The actual costs for the housing adaptation, including costs for travel, work hours, and material will be calculated based on invoices benefit
|
3,6, 12, 24 and 36 months after, for the whole sample
|
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Cost-benefit for client and society
Prazo: At 24 and 36 months after the housing adaptation, for the whole sample
|
The cost-benefit of the housing adaptation will be calculated based on health economic models utilising data from EQ-5D instrument
|
At 24 and 36 months after the housing adaptation, for the whole sample
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Agneta M Fänge, PhD, Lund University
Publicações e links úteis
Publicações Gerais
- Malmgren Fange A, Carlsson G, Axmon A, Thordardottir B, Chiatti C, Nilsson MH, Ekstam L. Effects of applying a standardized assessment and evaluation protocol in housing adaptation implementation - results from a quasi-experimental study. BMC Public Health. 2019 Nov 4;19(1):1446. doi: 10.1186/s12889-019-7815-9.
- Ekstam L, Carlsson G, Chiatti C, Nilsson MH, Malmgren Fange A. A research-based strategy for managing housing adaptations: study protocol for a quasi-experimental trial. BMC Health Serv Res. 2014 Nov 29;14:602. doi: 10.1186/s12913-014-0602-5.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- FORMAS 2011-907
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