- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Lund, Svezia, 221 00
- Department of Health Sciences, Lund University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Persons receiving housing adaptation
- Above 20 years
Exclusion Criteria:
- Persons with language deficits and/or cognitive decline
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: New Practice Strategy
Structured strategy for assessment and evaluation before and after intervention
|
Application of a structured case management strategy on housing adaptation cases
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|
Nessun intervento: Ordinary practice
Ordinary practice, not structured
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
ADL Staircase
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Falls Efficacy Scale- FES-I
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Usability of the home, UIMH
Lasso di tempo: 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
Lasso di tempo: 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
|
|
Cost-benefit for client and society
Lasso di tempo: 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
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At 24 and 36 months after the housing adaptation, for the whole sample
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Agneta M Fänge, PhD, Lund University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- FORMAS 2011-907
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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