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Clinical Trials/NCT00927706
NCT00927706CompletedPhase 2

Experimental Control Investigation of the Impact of an Assistive Technology Updating and Tune up Intervention on the User-caregiver Dyad: a Multi-site Trial

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal5 sites in 1 country88 target enrollmentStarted: June 2009Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
88
Locations
5
Primary Endpoint
Assessment of Life Habits

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Assessment of Life Habits

Time Frame: baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later

Caregivers: Caregiver Assistive Technology Outcome Measure

Time Frame: base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later

Secondary Outcomes

  • Functional Autonomy Measurement System(Baseline (1 or 2 times), Immediately after intervention, 16 weeks later)
  • Psychological Impact of Assistive Devices Scale(Imediately after intervention. 16 weeks later)
  • Individually Prioritized Problem Assessment(Baseline (1 or 2 times), Immediately after intervention, 16 weeks later)
  • Satisfaction with Personal Assistance Strategy(Baseline (1 or 2 times), Immediately after intervention, 16 weeks later)

Investigators

Sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Louise Demers

Département de l'ergothérapie

Université de Montréal

Study Sites (5)

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