Clinical trial NCT00927706: Experimental Control Investigation of the Impact of Assistive Technology on the User-caregiver Dyad: a Multi-site Trial
Official title: Experimental Control Investigation of the Impact of an Assistive Technology Updating and Tune up Intervention on the User-caregiver Dyad: a Multi-site Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mobility Limitations
Keywords: Assistive Technology
Mobility Limitation
Physical Disability
Caregiver
Participation
Lead sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Sponsor class: OTHER
First posted: 2009-06-25
Enrollment: 88
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Life Habits
timeFrame: baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
measure: Caregivers: Caregiver Assistive Technology Outcome Measure
timeFrame: base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later
Secondary outcomes:
measure: Individually Prioritized Problem Assessment
timeFrame: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
measure: Functional Autonomy Measurement System
timeFrame: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
measure: Psychological Impact of Assistive Devices Scale
timeFrame: Imediately after intervention. 16 weeks later
measure: Satisfaction with Personal Assistance Strategy
timeFrame: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Other outcomes:
Locations:
city: Vancovuer
country: Canada
facility: Simon Fraser University
state: British Columbia
city: Montreal
country: Canada
facility: Centre de santé et des services sociaux de Bordeaux-Cartierville--St-Laurent
state: Quebec
city: Montreal
country: Canada
facility: the Centre de santé et des services sociaux Cavendish
state: Quebec
city: Montreal
country: Canada
facility: the Centre de santé et des services sociaux de Laval
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Louise Demers, PhD
role: PRINCIPAL_INVESTIGATOR
References: