- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
British Columbia
-
Vancovuer, British Columbia, Canada, V6B 5K3
- Simon Fraser University
-
-
Quebec
-
Montreal, Quebec, Canada
- Centre de santé et des services sociaux de Bordeaux-Cartierville--St-Laurent
-
Montreal, Quebec, Canada
- the Centre de santé et des services sociaux Cavendish
-
Montreal, Quebec, Canada
- the Centre de santé et des services sociaux de Laval
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Assessment of Life Habits
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Individually Prioritized Problem Assessment
Tidsramme: 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
Tidsramme: 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
Tidsramme: Imediately after intervention. 16 weeks later
|
Imediately after intervention. 16 weeks later
|
Satisfaction with Personal Assistance Strategy
Tidsramme: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
|
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Louise Demers, PhD, Université de Montréal
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CRIUM-8317
- NIDRR: H133A060062
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Kliniske forsøg med Mobilitetsbegrænsninger
-
Hospices Civils de LyonIkke rekrutterer endnu
Kliniske forsøg med Assistive technology updating and tune up intervention
-
Johns Hopkins UniversityChildren's Hospital of Philadelphia; Columbia University; Research Foundation... og andre samarbejdspartnereIkke rekrutterer endnuSelvmord, Forsøg | Selvmord | Selvmordstanker | Selvmordsforebyggelse