- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
British Columbia
-
Vancovuer, British Columbia, Kanada, V6B 5K3
- Simon Fraser University
-
-
Quebec
-
Montreal, Quebec, Kanada
- Centre de santé et des services sociaux de Bordeaux-Cartierville--St-Laurent
-
Montreal, Quebec, Kanada
- the Centre de santé et des services sociaux Cavendish
-
Montreal, Quebec, Kanada
- the Centre de santé et des services sociaux de Laval
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Assessment of Life Habits
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Individually Prioritized Problem Assessment
Tidsram: 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
Tidsram: 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
Tidsram: Imediately after intervention. 16 weeks later
|
Imediately after intervention. 16 weeks later
|
Satisfaction with Personal Assistance Strategy
Tidsram: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
|
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Louise Demers, PhD, Université de Montréal
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CRIUM-8317
- NIDRR: H133A060062
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