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

Sponsor

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal (Other)

Overall Status

Completed

CT.gov ID

NCT00927706

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mobility Limitations	Device: Assistive technology updating and tune up intervention	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Simon Fraser University	Vancovuer	British Columbia	Canada	V6B 5K3
2	Centre de santé et des services sociaux de Bordeaux-Cartierville--St-Laurent	Montreal	Quebec	Canada
3	the Centre de santé et des services sociaux Cavendish	Montreal	Quebec	Canada
4	the Centre de santé et des services sociaux de Laval	Montreal	Quebec	Canada