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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:
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

June 24, 2009
February 14, 2014
June 2009
August 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Users: Participation Survey/Mobility. [ 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 ]
Complete list of historical versions of study NCT00927706 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Experimental Control Investigation of the Impact of Assistive Technology on the User-caregiver Dyad: a Multi-site Trial
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Mobility Limitations
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: Immediate intervention
    Subjects and their caregivers randomized to this arm receive the intervention immediately after baseline data is collected.
    Intervention: Device: Assistive technology updating and tune up intervention
  • 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).
    Intervention: Device: Assistive technology updating and tune up intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00927706
CRIUM-8317, NIDRR: H133A060062
No
Louise Demers, Université de Montréal
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Not Provided
Principal Investigator: Louise Demers, PhD Université de Montréal
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP