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

NCT00927706 | Completed Phase 2

• 2 other identifiers: CRIUM-8317NIDRR: H133A060062
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 4

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.

Conditions

Mobility Limitations

Keywords

Assistive Technology; Mobility Limitation; Physical Disability; Caregiver; Participation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Immediate intervention

EXPERIMENTAL

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

Delayed Intervention

EXPERIMENTAL

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

Interventions

Assistive technology updating and tune up intervention DEVICE

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.

Delayed Intervention; Immediate intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: lead

Study Sites (4)

Simon Fraser University

Vancovuer, British Columbia, V6B 5K3, Canada

Location

Centre de santé et des services sociaux de Bordeaux-Cartierville--St-Laurent

Montreal, Quebec, Canada

Location

the Centre de santé et des services sociaux Cavendish

Montreal, Quebec, Canada

Location

the Centre de santé et des services sociaux de Laval

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Louise Demers, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Département de l'ergothérapie

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 25, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

CA (4)