- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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British Columbia
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Vancovuer, British Columbia, Kanada, V6B 5K3
- Simon Fraser University
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Quebec
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Montreal, Quebec, Kanada
- Centre de santé et des services sociaux de Bordeaux-Cartierville--St-Laurent
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Montreal, Quebec, Kanada
- the Centre de santé et des services sociaux Cavendish
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Montreal, Quebec, Kanada
- the Centre de santé et des services sociaux de Laval
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
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Experimentální: 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).
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Assessment of Life Habits
Časové okno: baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
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baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
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Caregivers: Caregiver Assistive Technology Outcome Measure
Časové okno: base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later
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base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Individually Prioritized Problem Assessment
Časové okno: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
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Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
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Functional Autonomy Measurement System
Časové okno: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
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Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
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Psychological Impact of Assistive Devices Scale
Časové okno: Imediately after intervention. 16 weeks later
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Imediately after intervention. 16 weeks later
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Satisfaction with Personal Assistance Strategy
Časové okno: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
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Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Louise Demers, PhD, Université de Montréal
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CRIUM-8317
- NIDRR: H133A060062
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Klinické studie na Assistive technology updating and tune up intervention
-
University of California, San FranciscoDokončenoPříznaky deprese | Příznaky úzkostiSpojené státy
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