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

Mobility Limitations Clinical Trial

— ATUTI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927706
• Other study ID #: CRIUM-8317
• Secondary ID: NIDRR: H133A0600
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2009
• Last updated: February 14, 2014
• Start date: June 2009
• Est. completion date: August 2011

Study information

• Verified date: February 2014
• Source: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mobility Limitation
• Mobility Limitations

Intervention

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.

Locations

Country	Name	City	State
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	Simon Fraser University	Vancovuer	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Life Habits		baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later	No
Primary	Caregivers: Caregiver Assistive Technology Outcome Measure		base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later	No
Secondary	Individually Prioritized Problem Assessment		Baseline (1 or 2 times), Immediately after intervention, 16 weeks later	No
Secondary	Functional Autonomy Measurement System		Baseline (1 or 2 times), Immediately after intervention, 16 weeks later	No
Secondary	Psychological Impact of Assistive Devices Scale		Imediately after intervention. 16 weeks later	No
Secondary	Satisfaction with Personal Assistance Strategy		Baseline (1 or 2 times), Immediately after intervention, 16 weeks later	No