Mobility LimitationsPhase 2ATUTINCT00927706
Experimental Control Investigation of the Impact of Assistive Technology on the User-caregiver Dyad: a Multi-site Trial
A Phase 2 study testing Assistive technology updating and tune up intervention in people with Mobility Limitations, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 4 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mobility Limitations
- What is being tested?
- Assistive technology updating and tune up intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesCanada
- Study dates
- Jun 2009to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Centre de santé et des services sociaux de Bordeaux-Cartierville--St-Laurent
Montreal, Quebec
the Centre de santé et des services sociaux Cavendish
Montreal, Quebec
the Centre de santé et des services sociaux de Laval
Montreal, Quebec
Simon Fraser University
Vancovuer, British Columbia, V6B 5K3
About this study
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
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.
Read more
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
- Being tested
- Assistive technology updating and tune up intervention
- Keywords
- Assistive Technology, Mobility Limitation, Physical Disability, Caregiver, Participation
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assistive technology updating and tune up interventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention | Experimental | Subjects and their caregivers randomized to this arm receive the intervention immediately after baseline data is collected. Receives: 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). Receives: Device: Assistive technology updating and tune up intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Life Habits
Measured: baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
Caregivers: Caregiver Assistive Technology Outcome Measure
Measured: base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later
Secondary outcomes (4)
Individually Prioritized Problem Assessment
Measured: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Functional Autonomy Measurement System
Measured: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Psychological Impact of Assistive Devices Scale
Measured: Imediately after intervention. 16 weeks later
Satisfaction with Personal Assistance Strategy
Measured: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Demers, Université de Montréal
- Investigators
- Louise Demers, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927706
- Sponsor's protocol ID
- CRIUM-8317
- Other IDs
- NIDRR: H133A060062
- Acronym
- ATUTI
- Status last verified
- Feb 2014
- First submitted
- 24 Jun 2009
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00927706
- Acronym / sponsor ID
- ATUTI / CRIUM-8317
- Conditions
- Mobility Limitations
- Keywords
- Assistive Technology, Mobility Limitation, Physical Disability, Caregiver, Participation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention | Experimental | Device: Assistive technology updating and tune up interventionSubjects and their caregivers randomized to this arm receive the intervention immediately after baseline data is collected. |
| Delayed Intervention | Experimental | Device: Assistive technology updating and tune up interventionSubjects and their caregivers who are randomized to this group will receive the intervention after baseline measurements are administered twice (6 weeks apart). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assistive technology updating and tune up interventionThis 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. | Device | Delayed Intervention, Immediate intervention |
Primary outcome
Assessment of Life Habits
Time frame: baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later
Caregivers: Caregiver Assistive Technology Outcome Measure
Time frame: base line (1 or 2), 6 weeks (immediately after intervention), 16 weeks later
4 secondary outcomes
Individually Prioritized Problem Assessment
Time frame: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Functional Autonomy Measurement System
Time frame: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Psychological Impact of Assistive Devices Scale
Time frame: Imediately after intervention. 16 weeks later
Satisfaction with Personal Assistance Strategy
Time frame: Baseline (1 or 2 times), Immediately after intervention, 16 weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Demers, PhD principal investigator
Université de Montréal
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Assistive technology updating and tune up intervention in people with Mobility Limitations, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Life Habits (time frame: baseline (1or 2 times), 6 weeks (immediately after intervention), 16 weeks later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.