Mobility DisabilityPhase 2CATSNCT01640470
A Multi-Site Trial of the Impact of Assistive Technology With Assistance Users and Their Caregivers
A Phase 2 study testing Assistive Technology Provision and Tune-Up Intervention and Customary Care in people with Mobility Disability and Older Adults, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 3 sites in Canada.
Trial summary
Many individuals with mobility limitations, especially those who are older and have more severe impairments, use a combination of assistive devices and personal assistance to meet their needs. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mobility Disability, Older Adults, Community Dwelling
- What is being tested?
- Assistive Technology Provision and Tune-Up Intervention and Customary Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesCanada
- Study dates
- Dec 2011to Mar 2017
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- daily activity and/or mobility disability
- referred to homecare
- have an unpaid informal caregiver who is above the age of consent and willing to participate in the study
- can communicate in English or French.
Who cannot join
- cognitive impairments that are likely to prevent them from reliably completing the study questionnaires.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of Montreal
Montreal, Quebec, H3W 1W5
Élisabeth Bruyère Research Centre
Ottawa, Ontario, K1N 5C8
Simon Fraser University- Gerontolgy Research Centre
Vancouver, British Columbia, V6B 5K3
About this study
Official title: A Multi-Site Trial of the Impact of Assistive Technology With Individuals With Mobility Limitations and Their Caregivers.
Many individuals with mobility limitations, especially those who are older and have more severe impairments, use a combination of assistive devices and personal assistance to meet their needs. Assistive technology (AT), which includes devices such as wheelchairs, walkers, bathroom grab bars, and dressing aids, helps facilitate day-to-day activities and social participation (basic and instrumental activities of daily living) among these individuals and may decrease their dependence on human assistance. Although some research has reported beneficial outcomes of AT use, few studies have used controlled experimental designs. Furthermore, the results are often difficult to interpret because the AT interventions are only vaguely described. Another concern is that many individuals receive help from others, but scant attention has been paid to the impact of AT on caregivers. This neglect produces an incomplete portrayal of the effect of AT interventions. The proposed study addresses these deficiencies by evaluating the effects of a formalized dyadic AT intervention on individuals with mobility limitations and on their caregivers. The Assistive Technology Provision, Updating and Training (ATPUT)intervention involves a detailed in-home assessment of participants' current AT; the negotiation and implementation of a personal AT plan with the participants and their caregivers; and the provision of AT devices, non-structural home modifications, and device training.
Objectives:
Read more
- To determine the efficacy of the Assistive Technology Provision, Updating and Training intervention for assistance users and for their caregivers.
- To explore how the intervention is experienced by these individuals and to help explain the study findings.
General Hypotheses:
The investigators anticipate this intervention will increase the daily activities and social participation of individuals with mobility limitations; decrease the psychological and physical demands on caregivers; and reduce the amount of caregiving required.
Methodologies:
This research will use a combination of quantitative and qualitative methods. The quantitative portion will be an experimental, single-blinded study in which the investigators randomly assign participants to either the ATPUT or a customary care group.
- Conditions
- Mobility Disability, Older Adults, Community Dwelling
- Being tested
- Assistive Technology Provision and Tune-Up Intervention, Customary Care
- Keywords
- assistive technology, environmental modification, caregiver, client-centred
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assistive Technology Provision and Tune-Up InterventionDevice
The home based AT Provision, Updating and Tune-Up (ATPUT) Intervention will consist of 5 components: 1) identification and prioritization of problematic activities by the assistance user and his/her principal, cohabitating caregiver; 2) in-residence assessment of the daily activities and social participation and preferences of the assistance user; 3) detailed review of the AT and human assistance that are currently being used; 4) recommendations by an occupational therapist for possible changes in the personal assistance strategy; 5) negotiation of an ATPUT Personal Plan with the assistance user and her/his principal caregiver.
The intervention occurs over a six week period and involves 3 to 6 visits from an occupational therapist.
Customary CareDevice
Also called Customary device prescription and training
Participants in the customary care group receive normal occupational therapy services.Occupational Therapy
| Study group | Role | What they receive |
|---|---|---|
| Assistive technology | Experimental | The home based AT Provision, Updating and Tune-Up (ATPUT) Intervention will include recommendations for assistive technology, possibly entailing financial assistance to repair or to acquire new AT, and training. New equipment will likely include devices such as bathroom grab bars, raised toilet seats, walkers, and bath chairs. Receives: Device: Assistive Technology Provision and Tune-Up Intervention |
| Customary care | Active comparator | Participants in this arm will receive customary care. Receives: Device: Customary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Assistive Technology Outcome Measure
The caregiver assistive technology outcome measure captures physical and psychological associated with informal care provision.
Measured: 58 Weeks
Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF))
A composite from two sub-scales of the SMAF will be used the primary outcome measure for users (self-care and mobility)
Measured: 58 weeks
Secondary outcomes (7)
Sub-scale scores from the Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF))
Three sub-scales from the Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF)) (self-care, mobility and instrumental) will be used as secondary outcome measures for assistance users.
Measured: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3)
Sub-scale scores from the Caregiver Assistive Technology Outcome Measure
For caregivers, sub-scale scores of frequency of physical and psychological burden from the CATOM will be used.
Measured: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Euro-QOL 5
For caregivers, health-related quality of life. Health related quality of life will be measured using the EuroQol,
Measured: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Caregiver Burden Inventory
A composite score from the first three subscales of the Caregiver Burden Inventory will be used as a secondary outcome measure for caregivers.
Measured: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Reintegration to Normal Living Index (RNLI)
The RNLI will measure problems with social participation among assistance users.
Measured: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Self-report of Functional Independence
Assistance users and caregivers will independently evaluate perceived functional Independence of assistance users.
Measured: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Qualitative interviews
A purposive sample of participants will be interviewed immediately after the intervention and at the end of the study to understand better how the intervention was administered by therapists and experienced by assistance users and their caregivers.
Measured: week 6 and week 58
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startDec 2011
- Primary completionMay 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mobility DisabilityStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Simon Fraser University, Duke University, University of Ottawa
- Responsible party
- Principal investigator, Louise Demers, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Investigators
- Louise Demers, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640470
- Sponsor's protocol ID
- 232262
- Acronym
- CATS
- Status last verified
- Apr 2016
- First submitted
- 21 Nov 2011
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ben Mortenson W, Demers L, Fuhrer MJ, Jutai JW, Bilkey J, Plante M, DeRuyter F. Effects of a caregiver-inclusive assistive technology intervention: a randomized controlled trial. BMC Geriatr. 2018 Apr 18;18(1):97. doi: 10.1186/s12877-018-0783-6.
PubMed 29669536Demers L, Mortenson WB, Fuhrer MJ, Jutai JW, Plante M, Mah J, DeRuyter F. Effect of a tailored assistive technology intervention on older adults and their family caregiver: a pragmatic study protocol. BMC Geriatr. 2016 May 13;16:103. doi: 10.1186/s12877-016-0269-3.
PubMed 27177609
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Trial of the Impact of Assistive Technology With Individuals With Mobility Limitations and Their Caregivers.
- ClinicalTrials.gov ID
- NCT01640470
- Acronym / sponsor ID
- CATS / 232262
- Conditions
- Mobility Disability, Older Adults, Community Dwelling
- Keywords
- assistive technology, environmental modification, caregiver, client-centred
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealUniversity, hospital or other
- Collaborators
- Simon Fraser University, Duke University, University of Ottawa
- Study start
- Dec 2011
- Primary completion
- May 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 13 Jul 2012 (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.
Many individuals with mobility limitations, especially those who are older and have more severe impairments, use a combination of assistive devices and personal assistance to meet their needs. Assistive technology (AT), which includes devices such as wheelchairs, walkers, bathroom grab bars, and dressing aids, helps facilitate day-to-day activities and social participation (basic and instrumental activities of daily living) among these individuals and may decrease their dependence on human assistance. Although some research has reported beneficial outcomes of AT use, few studies have used controlled experimental designs. Furthermore, the results are often difficult to interpret because the AT interventions are only vaguely described. Another concern is that many individuals receive help from others, but scant attention has been paid to the impact of AT on caregivers. This neglect produces an incomplete portrayal of the effect of AT interventions. The proposed study addresses these deficiencies by evaluating the effects of a formalized dyadic AT intervention on individuals with mobility limitations and on their caregivers. The Assistive Technology Provision, Updating and Training (ATPUT)intervention involves a detailed in-home assessment of participants' current AT; the negotiation and implementation of a personal AT plan with the participants and their caregivers; and the provision of AT devices, non-structural home modifications, and device training.
Objectives:
- To determine the efficacy of the Assistive Technology Provision, Updating and Training intervention for assistance users and for their caregivers.
- To explore how the intervention is experienced by these individuals and to help explain the study findings.
General Hypotheses:
The investigators anticipate this intervention will increase the daily activities and social participation of individuals with mobility limitations; decrease the psychological and physical demands on caregivers; and reduce the amount of caregiving required.
Methodologies:
This research will use a combination of quantitative and qualitative methods. The quantitative portion will be an experimental, single-blinded study in which the investigators randomly assign participants to either the ATPUT or a customary care group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assistive technology | Experimental | Device: Assistive Technology Provision and Tune-Up InterventionThe home based AT Provision, Updating and Tune-Up (ATPUT) Intervention will include recommendations for assistive technology, possibly entailing financial assistance to repair or to acquire new AT, and training. New equipment will likely include devices such as bathroom grab bars, raised toilet seats, walkers, and bath chairs. |
| Customary care | Active comparator | Device: Customary CareParticipants in this arm will receive customary care. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- daily activity and/or mobility disability
- referred to homecare
- have an unpaid informal caregiver who is above the age of consent and willing to participate in the study
- can communicate in English or French.
Key exclusion criteria (1 listed)
- cognitive impairments that are likely to prevent them from reliably completing the study questionnaires.
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 Provision and Tune-Up InterventionThe home based AT Provision, Updating and Tune-Up (ATPUT) Intervention will consist of 5 components: 1) identification and prioritization of problematic activities by the assistance user and his/her principal, cohabitating caregiver; 2) in-residence assessment of the daily activities and social participation and preferences of the assistance user; 3) detailed review of the AT and human assistance that are currently being used; 4) recommendations by an occupational therapist for possible changes in the personal assistance strategy; 5) negotiation of an ATPUT Personal Plan with the assistance user and her/his principal caregiver. The intervention occurs over a six week period and involves 3 to 6 visits from an occupational therapist. | Device | Assistive technology |
| Customary CareAlso: Customary device prescription and trainingParticipants in the customary care group receive normal occupational therapy services.Occupational Therapy | Device | Customary care |
Primary outcome
Caregiver Assistive Technology Outcome Measure
Time frame: 58 Weeks
The caregiver assistive technology outcome measure captures physical and psychological associated with informal care provision.
Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF))
Time frame: 58 weeks
A composite from two sub-scales of the SMAF will be used the primary outcome measure for users (self-care and mobility)
7 secondary outcomes
Sub-scale scores from the Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF))
Time frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3)
Sub-scale scores from the Caregiver Assistive Technology Outcome Measure
Time frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Euro-QOL 5
Time frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Caregiver Burden Inventory
Time frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Reintegration to Normal Living Index (RNLI)
Time frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Self-report of Functional Independence
Time frame: baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).
Qualitative interviews
Time frame: week 6 and week 58
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Derived from this study: PubMed 29669536Ben Mortenson W, Demers L, Fuhrer MJ, Jutai JW, Bilkey J, Plante M, DeRuyter F. Effects of a caregiver-inclusive assistive technology intervention: a randomized controlled trial. BMC Geriatr. 2018 Apr 18;18(1):97. doi: 10.1186/s12877-018-0783-6.
- Derived from this study: PubMed 27177609Demers L, Mortenson WB, Fuhrer MJ, Jutai JW, Plante M, Mah J, DeRuyter F. Effect of a tailored assistive technology intervention on older adults and their family caregiver: a pragmatic study protocol. BMC Geriatr. 2016 May 13;16:103. doi: 10.1186/s12877-016-0269-3.
Related trials for Mobility Disability
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Effect of Kendall Versus McKenzie Exercises in Patients With Upper Crossed Syndrome
Upper Crossed Syndrome
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
Active, not recruiting
Hypopressive-Core Stabilization With and Without Whole-Body Vibration in Postpartum Pelvic Girdle Pain
Postpartum Pelvic Girdle Pain
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
3 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 Provision and Tune-Up Intervention and Customary Care in people with Mobility Disability and Older Adults, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 3 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 4 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: status not confirmed, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
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?
Caregiver Assistive Technology Outcome Measure (time frame: 58 Weeks). 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?
On the ClinicalTrials.gov record for NCT01640470, which also lists 2 linked publications.
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 11 Apr 2016.