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

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.

Study Overview

• Status: Completed
• Conditions: Mobility Limitations
• Intervention / Treatment: Device: Assistive technology updating and tune up intervention

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancovuer, British Columbia, Canada, V6B 5K3
      • Simon Fraser University
  • Quebec
    • Montreal, Quebec, Canada
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of Life Habits	baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
Caregivers: Caregiver Assistive Technology Outcome Measure	base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later

Secondary Outcome Measures

Outcome Measure	Time Frame
Individually Prioritized Problem Assessment	Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
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
Satisfaction with Personal Assistance Strategy	Baseline (1 or 2 times), Immediately after intervention, 16 weeks later

Collaborators and Investigators

• Sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
• Investigators: Principal Investigator: Louise Demers, PhD, Université de Montréal

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: June 24, 2009
• First Submitted That Met QC Criteria: June 24, 2009
• First Posted (Estimate): June 25, 2009

Study Record Updates

• Last Update Posted (Estimate): February 19, 2014
• Last Update Submitted That Met QC Criteria: February 14, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Caregiver; Participation; Assistive Technology; Mobility Limitation; Physical Disability
• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: CRIUM-8317; NIDRR: H133A060062