- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Lund, Suecia, 221 00
- Department of Health Sciences, Lund University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Persons receiving housing adaptation
- Above 20 years
Exclusion Criteria:
- Persons with language deficits and/or cognitive decline
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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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Sin intervención: Ordinary practice
Ordinary practice, not structured
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
ADL Staircase
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Falls Efficacy Scale- FES-I
Periodo de tiempo: 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
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Differences in changes between intervention and control sites at baseline and 3, 6, 12, 24 and 36 months after
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Usability of the home, UIMH
Periodo de tiempo: 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
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Differences in changes between intervention and control sites between baseline and 3, 6,12,24 and 36 months after
|
|
Costs of housing adaptations
Periodo de tiempo: 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
Periodo de tiempo: At 24 and 36 months after the housing adaptation, for the whole sample
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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
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- FORMAS 2011-907
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