Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03394599 |
| Other study ID # |
Motiview Project |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2018 |
| Est. completion date |
February 28, 2019 |
Study information
| Verified date |
September 2021 |
| Source |
Bruyere Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Motiview, an activity healthcare solution by Motitech, is finding solutions for elderly and
people with dementia by reducing unnecessary emergency department visits, preventing
falls/fall-injuries, improving management of complex health conditions, and improving brain
health/cognitive fitness. Motiview is based on the premise that many of the challenges faced
by this population may be caused by inactivity. The solution needs to effectively motivate
them to be active year round. It also needs to accomplish this without increasing the
resources within the health system. Motiview stimulates elderly people and people with
dementia to increase their physical activity and cognitive training. By using videos,
music/sound, the user can take a virtual bicycle trip through familiar surroundings and
memories while facilitating activity participation and adherence in the older adult. Motiview
is coupled to a mobile user-adapted cycle-trainer (TheraTrainer) that elicits physical
activity as the individual pedals the trip. The unique part is adapting films and music
according to the users' wishes and memories. By lessening the perceptions of difficulty,
monotony, and discomforts associated with physical activity, participation and the experience
of physical activity is enhanced. The research protocol of this project is designed to
document the added value of Motiview for achieving physical activity participation. The
hypothesis being that TheraTrainer bicycles will provide more activity when used with the
video/audio overlay. Qualitative data will be gathered on the social aspects and reminiscence
observed with the video/audit overlay from clients, care givers and staff.
Information about Motiview can also be found on the website at https://www.motitech.no/en
Description:
Implementation will be conducted in two settings (Geriatric Day Hospital (GDH) Elisabeth
Bruyere Hospital and the Day Treatment Centre (DTC) Baycrest Health Sciences). The settings
selected have similar client profiles in terms of age, frailty, cognition, etc. Three subject
groups will be included to obtain a holistic understanding of the use of this technology:
geriatric program clients (clients) and their carers (carer) and staff (staff). All subjects
(clients, carers and staff) will consent to participate prior to continuing with study
involvement as documented below.
Recruitment and Consent:
- Baycrest -
Clients
DTC clients will undergo their usual intake assessment conducted by the DTC clinical team.
Any clients who are determined to be medically unstable based on this assessment will not be
recruited for this study. At the end of this assessment, any clients who are eligible for the
study will be introduced to the study by the intake team. If they verbally consent to finding
out more details about the project, their contact information will be provided to a research
assistant (RA) who will then call the client with more information. If the client agrees to
participate, they will be scheduled to meet the RA when they attend their regular DTC session
during a time that does not conflict with treatment interventions or regular programming. At
this point, the clients may choose to take part in a consenting session with the RA, followed
by baseline testing. As a risk management strategy, the DTC clinical team will inform the
research staff if a client is determined to be unable to continue participation at any point
in the study.
Carers
Carers will be asked to contact the RA if they have any questions regarding the research
project or if they would like to participate. On this call, the RA will confirm their
understanding of their involvement in the research project. If the carers agree to
participate, they will attend a session at Baycrest. During this session, the details of
participation will be explained and the carers will be asked to repeat the information that
has just been discussed, in order to ensure that they understand the consent form. Once they
are fully informed, they will sign the consent form.
Staff
Following an informational session, consent forms will be left with the staff for them to
read on their own. They will be told to contact the RA if they have any questions regarding
the research project or if they decide to participate. The RA will then go to them at the DTC
to collect the consent form and will ensure understanding of their participation at this
time.
- Bruyere -
Clients
On the initial intake call by the GDH staff, all clients will be informed that there are
research projects at the GDH that they may be eligible for. A verbal consent to contact will
be obtained over the phone during this initial call. Contact information will then be sent to
a recruitment coordinator who will then obtain consent for chart review to assess for
eligibility for the research projects. Provided the client meets the inclusion criteria for
the research project, the recruitment coordinator will then call back to inform them that
they are eligible for participation and asked for verbal consent to be contacted by a member
of the research team. If the client agrees to participate, they will be then invited to
Bruyere prior to their GDH program to provide written consent and for baseline testing.
Carers
Following consenting and baseline testing with the client, the client will be told that the
project is also interested in the perceptions of carers (family, informal carers). Clients
will be asked to inform their carers of the study and to provide the RA's contact information
so the carer can call with any questions. The carer will be subsequently invited to attend
the baseline testing to provide written consent and to complete a semi-structured interview.
Staff
An informational session regarding Motiview will be provided to inform staff about the
research project. Consent forms will be left at the end of the meeting for staff to read
through on their own. If they decide to participate, they can leave their signed forms with
the GDH reception for the research assistant in sealed envelopes that will be provided to
them.
Study methods:
- Baycrest -
Clients
Participation: After the consenting and initial (baseline) testing session (which will be
held at a time convenient to the client attending the DTC program, and which does not
interfere with their regular programming/treatment intervention), the client will attend
their day treatment program as usual (i.e., 3 hours a day, twice a week on either Monday &
Wednesday or Tuesday & Thursday, for a duration of approximately 12 weeks). At Baycrest,
assignment to the experimental or control group will be determined by their day treatment
program schedule. If clients are scheduled for their program on Monday and Wednesday, they
will be provided with the opportunity to use the TheraTrainer with Motiview (Experimental
group). If they are scheduled for the program on Tuesday and Thursday, they will be provided
with the opportunity to use the TheraTrainer without Motiview (allocated to the control
group). Both groups will be informed that they have the option to use the TheraTrainer during
any free time between their scheduled treatment appointments, for the duration of their day
treatment program. Free time was selected so as to not disrupt a client's regularly scheduled
treatment plans.
Every time a participant chooses to use the TheraTrainer, an occupational/physical therapy
assistant hired for this project will assist the participant with his/her safe transfer onto
and from the TheraTrainer. The assistant will set up the TheraTrainer (and Motiview system,
if applicable). The assistant will record any field notes (i.e. reminiscence) that are
relevant for the study. After the completion of a cycling session, participants will be asked
micro-interview questions once per week to collect qualitative data about their cycling
session. In addition, the participants will be continuously observed by the
occupational/physical therapy assistant for the duration of each cycling session in the event
that any participant experiences adverse responses to the physical activity. If any concerns
arise related to the participants' ability to safely continue the cycling session, the
session will be ended.
Follow-up outcomes: At the end of the study, participants will be asked to attend a
post-participation session where they will participate in a post-participation
semi-structured interview.
Carers
Participation: After consent is obtained, the carers will be taken through a semi-structured
interview to gain feedback about their opinions about their study partner's involvement with
the TheraTrainer and/or Motiview. Also, they will be asked about their general
characteristics.
Follow-up: None for this group.
Staff
Participation: Following the study period, the staff will be taken through a semi-structured
interview to gain feedback about their opinions about the client's involvement with the
TheraTrainer and/or Motiview. Also, staff will be asked about their general characteristics.
Follow-up: None for this group.
- Bruyere -
Client
Participation: If the GDH client agrees to participate, they will be invited, along with
their caregiver to Bruyere for one visit of approximately 30 minutes prior to their
participation in the GDH. During this session, they will be told again of their involvement
requirements for this study and signed written consent will be obtained. Subsequently,
baseline outcome measure testing will be done.
They will then attend the rehabilitation program as usual and will be encouraged by the staff
as part of their regular GDH program to use the TheraTrainer (one group with Motiview, one
group without Motiview). At certain times throughout the study, when a participant uses the
TheraTrainer as part of this investigation, study staff will take field notes to capture the
clients'/residents' level of social engagement, and other behavioural or anecdotal findings
that may emerge immediately prior to, during, or shortly after the exercise session.
To assess clients' experiences, they will be approached by study staff once a week (on
different days throughout the week, depending on the client's schedule). The study staff will
ask the clients if they would like to answer a few short questions related to their
experience with the TheraTrainer (either with or without Motiview). Following their assent,
the clients will be asked a maximum of four short questions related to their exercise
experiences, reminiscence, and general health and well-being during each micro-interview.
Each client will have the opportunity to take part in up to six micro-interviews in total
throughout the study. The clients' responses will be audio recorded with their assent; for
those who do not wish to have their responses recorded, study staff will take field notes
related to the clients' responses instead (if assent is provided).
Follow-up: When each client has completed their GDH program, they will be asked to return to
the Bruyere Continuing Care (room 441D) to complete the baseline outcome measures as a
pre-post design.
Semi-structured interview questions will be posed to all clients who elect to take part in
interview session as part of the study. The interviews will be held at the end of the study
period. The questions and prompts were developed with the aim of employing a phenomenological
approach, enabling the clients to elicit their own responses and experiences. Using the
interview guide to lead the discussion, client responses may be probed to gain further
clarity or insight. The interviews will be audio recorded by study staff. Study staff will
also write field notes to document client responses and other observations to supplement and
provide context for the transcripts.
Recruitment will continue until 15 clients (control group) have been enrolled and all have
completed their geriatric rehabilitation program. After 15 clients have finished the study,
Motiview will be placed into the GDH and recruitment of 15 (experimental group) additional
clients will commence.
Carer
Same as Baycrest protocol.
Staff
Prior to the first client enrollment, staff will participate in a brief session
(approximately 10 minutes) on proper use of the TheraTrainer, Motiview. The staff will be
encouraged to use the TheraTrainer and Motiview as part of their rehabilitation protocol
(TheraTrainer activity bikes will be used in place of the NuStep cycle currently in the GDH).
Semi-structured interview questions will be posed to all staff members who elect to take part
in an interview session as part of the study. The interviews will be held after 15 clients
use the TheraTrainer alone as well as after the 15 clients that use TheraTrainer and
Motiview. The questions were developed with the aim of employing a phenomenological approach,
which provides staff with the opportunity to elicit their own responses and experiences.
Using the interview guide to lead the discussion, staff members' responses may be probed
further to gain additional clarity or insight. The interviews will be audio recorded by study
staff. Study staff will also write down field notes to capture any notable observations and
to add further context to clients' responses, which will ultimately supplement the
transcripts.
