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:
Information provided by (Responsible Party):
Louise Demers, Université de Montréal
ClinicalTrials.gov Identifier:
NCT00927706
First received: June 24, 2009
Last updated: February 14, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal:

Primary Outcome Measures:
  • Assessment of Life Habits [ Time Frame: baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later ] [ Designated as safety issue: No ]
  • Caregivers: Caregiver Assistive Technology Outcome Measure [ Time Frame: base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Individually Prioritized Problem Assessment [ Time Frame: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later ] [ Designated as safety issue: No ]
  • Functional Autonomy Measurement System [ Time Frame: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later ] [ Designated as safety issue: No ]
  • Psychological Impact of Assistive Devices Scale [ Time Frame: Imediately after intervention. 16 weeks later ] [ Designated as safety issue: No ]
  • Satisfaction with Personal Assistance Strategy [ Time Frame: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 24, 2009
Last Updated: February 14, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal:
Assistive Technology
Mobility Limitation
Physical Disability
Caregiver
Participation

Additional relevant MeSH terms:
Mobility Limitation
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014