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

NCT ID: NCT00927706

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate intervention

Subjects and their caregivers randomized to this arm receive the intervention immediately after baseline data is collected.

Group Type: EXPERIMENTAL

Assistive technology updating and tune up intervention

Intervention Type: 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

Subjects and their caregivers who are randomized to this group will receive the intervention after baseline measurements are administered twice (6 weeks apart).

Group Type: EXPERIMENTAL

Assistive technology updating and tune up intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Louise Demers

Département de l'ergothérapie

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louise Demers, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Locations

Simon Fraser University

Vancovuer, British Columbia, 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

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

NIDRR: H133A060062

Identifier Type: -

Identifier Source: secondary_id

CRIUM-8317

Identifier Type: -

Identifier Source: org_study_id