Experimental Control Investigation of the Impact of Assistive Technology on the User-caregiver Dyad: a Multi-site Trial (ATUTI)
Primary Purpose
Mobility Limitations
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Assistive technology updating and tune up intervention
Sponsored by
About this trial
This is an interventional treatment trial for Mobility Limitations focused on measuring Assistive Technology, Mobility Limitation, Physical Disability, Caregiver, Participation
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.
Sites / Locations
- Simon Fraser University
- Centre de santé et des services sociaux de Bordeaux-Cartierville--St-Laurent
- the Centre de santé et des services sociaux Cavendish
- the Centre de santé et des services sociaux de Laval
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Immediate intervention
Delayed Intervention
Arm Description
Subjects and their caregivers randomized to this arm receive the intervention immediately after baseline data is collected.
Subjects and their caregivers who are randomized to this group will receive the intervention after baseline measurements are administered twice (6 weeks apart).
Outcomes
Primary Outcome Measures
Assessment of Life Habits
Caregivers: Caregiver Assistive Technology Outcome Measure
Secondary Outcome Measures
Individually Prioritized Problem Assessment
Functional Autonomy Measurement System
Psychological Impact of Assistive Devices Scale
Satisfaction with Personal Assistance Strategy
Full Information
NCT ID
NCT00927706
First Posted
June 24, 2009
Last Updated
February 14, 2014
Sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
1. Study Identification
Unique Protocol Identification Number
NCT00927706
Brief Title
Experimental Control Investigation of the Impact of Assistive Technology on the User-caregiver Dyad: a Multi-site Trial
Acronym
ATUTI
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
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitations
Keywords
Assistive Technology, Mobility Limitation, Physical Disability, Caregiver, Participation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate intervention
Arm Type
Experimental
Arm Description
Subjects and their caregivers randomized to this arm receive the intervention immediately after baseline data is collected.
Arm Title
Delayed Intervention
Arm Type
Experimental
Arm Description
Subjects and their caregivers who are randomized to this group will receive the intervention after baseline measurements are administered twice (6 weeks apart).
Intervention Type
Device
Intervention Name(s)
Assistive technology updating and tune up intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of Life Habits
Time Frame
baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
Title
Caregivers: Caregiver Assistive Technology Outcome Measure
Time Frame
base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later
Secondary Outcome Measure Information:
Title
Individually Prioritized Problem Assessment
Time Frame
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Title
Functional Autonomy Measurement System
Time Frame
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Title
Psychological Impact of Assistive Devices Scale
Time Frame
Imediately after intervention. 16 weeks later
Title
Satisfaction with Personal Assistance Strategy
Time Frame
Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Demers, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simon Fraser University
City
Vancovuer
State/Province
British Columbia
ZIP/Postal Code
V6B 5K3
Country
Canada
Facility Name
Centre de santé et des services sociaux de Bordeaux-Cartierville--St-Laurent
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
the Centre de santé et des services sociaux Cavendish
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
the Centre de santé et des services sociaux de Laval
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Experimental Control Investigation of the Impact of Assistive Technology on the User-caregiver Dyad: a Multi-site Trial
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