A Multi-Site Trial of the Impact of Assistive Technology With Assistance Users and Their Caregivers (CATS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Sponsor:
Collaborators:
Simon Fraser University
Duke University
University of Ottawa
Information provided by (Responsible Party):
Louise Demers, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
ClinicalTrials.gov Identifier:
NCT01640470
First received: November 21, 2011
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

Many individuals with mobility limitations, especially those who are older and have more severe impairments, use a combination of assistive devices and personal assistance to meet their needs. Assistive technology (AT), which includes devices such as wheelchairs, walkers, bathroom grab bars, and dressing aids, helps facilitate day-to-day activities and social participation (basic and instrumental activities of daily living) among these individuals and may decrease their dependence on human assistance. Although some research has reported beneficial outcomes of AT use, few studies have used controlled experimental designs. Furthermore, the results are often difficult to interpret because the AT interventions are only vaguely described. Another concern is that many individuals receive help from others, but scant attention has been paid to the impact of AT on caregivers. This neglect produces an incomplete portrayal of the effect of AT interventions. The proposed study addresses these deficiencies by evaluating the effects of a formalized dyadic AT intervention on individuals with mobility limitations and on their caregivers. The Assistive Technology Provision, Updating and Training (ATPUT)intervention involves a detailed in-home assessment of participants' current AT; the negotiation and implementation of a personal AT plan with the participants and their caregivers; and the provision of AT devices, non-structural home modifications, and device training.

Objectives:

  1. To determine the efficacy of the Assistive Technology Provision, Updating and Training intervention for assistance users and for their caregivers.
  2. To explore how the intervention is experienced by these individuals and to help explain the study findings.

General Hypotheses:

The investigators anticipate this intervention will increase the daily activities and social participation of individuals with mobility limitations; decrease the psychological and physical demands on caregivers; and reduce the amount of caregiving required.

Methodologies:

This research will use a combination of quantitative and qualitative methods. The quantitative portion will be an experimental, single-blinded study in which the investigators randomly assign participants to either the ATPUT or a customary care group.


Condition Intervention Phase
Mobility Disability
Older Adults
Community Dwelling
Device: Assistive Technology Provision and Tune-Up Intervention
Device: Customary Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Site Trial of the Impact of Assistive Technology With Individuals With Mobility Limitations and Their Caregivers.

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:
  • Caregiver Assistive Technology Outcome Measure [ Time Frame: 58 Weeks ] [ Designated as safety issue: No ]
    The caregiver assistive technology outcome measure captures physical and psychological associated with informal care provision.

  • Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF)) [ Time Frame: 58 weeks ] [ Designated as safety issue: No ]
    A composite from three sub-scales of the SMAF will be used the primary outcome measure for users (self-care, mobility and instrumental)


Secondary Outcome Measures:
  • Sub-scale scores from the Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF)) [ Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3) ] [ Designated as safety issue: No ]
    Three sub-scales from the Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF)) (self-care, mobility and instrumental) will be used as secondary outcome measures for assistance users.

  • Sub-scale scores from the Caregiver Assistive Technology Outcome Measure [ Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3). ] [ Designated as safety issue: Yes ]
    For caregivers, sub-scale scores of frequency of physical and psychological burden from the CATOM will be used.

  • Euro-QOL 5 [ Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3). ] [ Designated as safety issue: No ]
    For caregivers, health-related quality of life. Health related quality of life will be measured using the EuroQol,

  • Caregiver Burden Inventory [ Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3). ] [ Designated as safety issue: No ]
    A composite score from the first three subscales of the Caregiver Burden Inventory will be used as a secondary outcome measure for caregivers.

  • Reintegration to Normal Living Index (RNLI) [ Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3). ] [ Designated as safety issue: No ]
    The RNLI will measure problems with social participation among assistance users.

  • Self-report of Functional Independence [ Time Frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3). ] [ Designated as safety issue: No ]
    Assistance users and caregivers will independently evaluate perceived functional Independence of assistance users.

  • Qualitative interviews [ Time Frame: week 6 and week 58 ] [ Designated as safety issue: No ]
    A purposive sample of participants will be interviewed immediately after the intervention and at the end of the study to understand better how the intervention was administered by therapists and experienced by assistance users and their caregivers.


Estimated Enrollment: 240
Study Start Date: December 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Assistive technology
The home based AT Provision, Updating and Tune-Up (ATPUT) Intervention will include recommendations for assistive technology, possibly entailing financial assistance to repair or to acquire new AT, and training. New equipment will likely include devices such as bathroom grab bars, raised toilet seats, walkers, and bath chairs.
Device: Assistive Technology Provision and Tune-Up Intervention

The home based AT Provision, Updating and Tune-Up (ATPUT) Intervention will consist of 5 components: 1) identification and prioritization of problematic activities by the assistance user and his/her principal, cohabitating caregiver; 2) in-residence assessment of the daily activities and social participation and preferences of the assistance user; 3) detailed review of the AT and human assistance that are currently being used; 4) recommendations by an occupational therapist for possible changes in the personal assistance strategy; 5) negotiation of an ATPUT Personal Plan with the assistance user and her/his principal caregiver.

The intervention occurs over a six week period and involves 3 to 6 visits from an occupational therapist.

Active Comparator: Customary care
Participants in this arm will receive customary care.
Device: Customary Care
Participants in the customary care group receive normal occupational therapy services.Occupational Therapy
Other Name: Customary device prescription and training

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mobility disability
  • referred to homecare
  • have an unpaid, cohabitating, informal caregiver who is above the age of consent and willing to participate in the study
  • can communicate in English or French.

Exclusion Criteria:

  • cognitive impairments that are likely to prevent them from reliably completing the study questionnaires.
  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: NCT01640470

Contacts
Contact: William B Mortenson, BscOT, PhD 778-782-7634 wmortens@sfu.ca

Locations
Canada, British Columbia
Simon Fraser University- Gerontolgy Research Centre Recruiting
Vancouver, British Columbia, Canada, V6B 5K3
Contact: William B Mortenson, PhD    778-782-7634    wmortens@sfu.ca   
Sub-Investigator: William B Mortenson, BScOT, PhD         
Principal Investigator: Andrew Sixsmith, PhD         
Canada, Ontario
Élisabeth Bruyère Research Centre Recruiting
Ottawa, Ontario, Canada, K1N 5C8
Contact: Stephanie Chamberlain    613-562-6262 ext 2245      
Principal Investigator: Jeffrey Jutai, PhD         
Canada, Quebec
University of Montreal Recruiting
Montreal, Quebec, Canada, H3W 1W5
Contact: Michelle Plante, BScOT, MSc       michelle.plante@criugm.qc.ca   
Principal Investigator: Louise Demers, PhD         
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Simon Fraser University
Duke University
University of Ottawa
Investigators
Principal Investigator: Louise Demers, PhD Université de Montréal
  More Information

No publications provided

Responsible Party: Louise Demers, Directrice, Département de l'ergothérapie, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
ClinicalTrials.gov Identifier: NCT01640470     History of Changes
Other Study ID Numbers: 232262
Study First Received: November 21, 2011
Last Updated: January 15, 2013
Health Authority: Canada: Health Canada

Keywords provided by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal:
assistive technology
environmental modification
caregiver
client-centred

ClinicalTrials.gov processed this record on August 21, 2014