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Experimental Control Investigation of the Impact of Assistive Technology on the User-caregiver Dyad: a Multi-site Trial (ATUTI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00927706
First Posted: June 25, 2009
Last Update Posted: February 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Louise Demers, Université de Montréal
  Purpose

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.

Condition Intervention Phase
Mobility Limitations Device: Assistive technology updating and tune up intervention Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Louise Demers, Université de Montréal:

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

Enrollment: 88
Study Start Date: June 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate intervention
Subjects and their caregivers randomized to this arm receive the intervention immediately after baseline data is collected.
Device: Assistive technology updating and tune up intervention
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.
Experimental: 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).
Device: Assistive technology updating and tune up intervention
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927706


Locations
Canada, British Columbia
Simon Fraser University
Vancovuer, British Columbia, Canada, V6B 5K3
Canada, Quebec
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
Montreal, Quebec, Canada
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Investigators
Principal Investigator: Louise Demers, PhD Université de Montréal
  More Information

Responsible Party: Louise Demers, Département de l'ergothérapie, Université de Montréal
ClinicalTrials.gov Identifier: NCT00927706     History of Changes
Other Study ID Numbers: CRIUM-8317
NIDRR: H133A060062
First Submitted: June 24, 2009
First Posted: June 25, 2009
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Louise Demers, Université de Montréal:
Assistive Technology
Mobility Limitation
Physical Disability
Caregiver
Participation

Additional relevant MeSH terms:
Mobility Limitation
Signs and Symptoms