To determine the (cost)effectiveness of OTHER (Occupational Therapy at Home E-Rehabilitation), as compared to usual OT, on improving the self-perceived performance in daily activities of community-dwelling older persons post-stroke over a 24-week…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Stroke/CVA
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the between group difference in *perceived daily
performance* 4 weeks, 13 weeks and 26 weeks after the start of the
intervention. This is measured by the Canadian Occupational Performance
Measure.
Secondary outcome
Secondary outcomes are patients satisfaction with their daily performance,
self-management, activity level and mobility, patients quality of life,
satisfaction with occupational therapy, and cost-effectiveness. Process
evaluation outcomes focus on how participants experienced OTHER in the
transition from a geriatric rehabilitation centre to home, treatment fidelity
and adherence to OTHER, and the facilitators and barriers persons post-stroke
and OTs experience.
Background summary
In the Netherlands, every year 40.000 people suffer from stroke, constituting
the third-largest burden of disease and responsible for 2.5% of total
healthcare costs. The exact stroke consequences depend on the location of the
stroke, e.g. limitations in sensory-motor, speech, cognitive and
social-emotional functioning . Also, stroke may affect partners, if any, often
in their role as caregiver they too may suffer from emotional and physical
burden. 23 % of persons who suffer from a stroke in the Netherlands went for
rehabilitation to a geriatric rehabilitation centre (GRC) after
hospitalization. During transition from GRC to home or transition fom hospital
to home, persons are confronted with reality and realize that they are often
not ready to take up daily activities and to self-manage. The majority of
persons post-stroke at home are inactive and sedentary. Breaking up sedentary
time with light activities of daily living is associated with health
indicators. Performance of daily activities is an important arena in which
persons post-stroke also develop self-management and being in charge.
Recognizing the demand on healthcare services, e-rehabilitation interventions
are a promising cost-effective solution to support GR at home for persons
post-stroke and e-rehabilitation can be applied to increase the performance of
daily activities, support self-management and be(com)ing in charge.
Therefore, persons post-stroke at home could benefit from Occupational Therapy
(OT) at Home E-Rehabilitation (OTHER), a program to support persons to increase
performance in daily activities and to support their post-stroke
self-management.
Study objective
To determine the (cost)effectiveness of OTHER (Occupational Therapy at Home
E-Rehabilitation), as compared to usual OT, on improving the self-perceived
performance in daily activities of community-dwelling older persons post-stroke
over a 24-week period after initiation of OTHER or CAU, as measured
longitudinally (at week 4, 12 and 24).
Study design
The (cost)effectiveness of OTHER will be evaluated in a 2-armed stepped-wedge
randomized trial in eight geriatric rehabilitation centres and two area's from
hospital to home in the Netherlands. Alongside the (cost-)effectiveness study,
we will conduct a process evaluation using mixed methods, to investigate
treatment fidelity and adherence to the intervention protocol. Moreover, we
will qualitatively evaluate patient and care personnel*s experiences, barriers
and facilitators and satisfaction with the intervention content and its
delivery.
Intervention
All participants receive home-based OT care as usual. Participants included
during intervention periods will additionally receive activity monitoring and
(online)coaching. The intervention starts during clinical geriatric
rehabilitation as soon as if it is clear that a participant is going home, at
least three weeks before discharge and ends 12 weeks after discharge or within
four weeks from discharg from hospital to home. The intervention from hospital
preferably starts within 4 weeks after discharge from hospital to home and
lasts 12 weeks.The intervention consists of a validated platform for activity
monitoring supported by face-to-face coaching and videoconferencing.
Participants receive a wearable sensor worn on the hip which measures the
amount of physical activity. Via a web-based application, participants can see
the visualization of their data. The therapist and participant monitor the
activities via a secure website and the daily and weekly reports of the sensor
data are used as feedback for coaching; patterns of daily activities are
discussed and related to experiences during the day. Accordingly, new goals for
daily activities can be set. The intervention will comprise a weekly coaching
session during inpatient rehabilitation and 6 physical sessions and 4 online
videoconference follow up sessions at home in 12 weeks.
Study burden and risks
The burden for participants is low, during baseline, at 4 weeks, 13 weeks
follow-up moments and 26 weeks follow up, study measurements will cost the
participant about one hour. The burden for professionals is low, filling in a
questionnaire for participants (5 minutes). A small group of participants (and
if involved during OTHER, also their informal caregiver) (max N= 20) will also
be approached for interviews which will last an hour and a small sample
(N=8-10) professionals will be asked to participate in a focus group (2 hours).
Tafelbergweg 51
Amsterdam 1105 BD
NL
Tafelbergweg 51
Amsterdam 1105 BD
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, the persons post-stroke must meet
all the following criteria:
• be able to walk a few steps with or without a walking device
• 60 years or older
• An assessment score of at least 16 on the Montreal Cognitive Assessment
(MoCA).
• An indication for follow up (GR) Rehabilitation at home.
Exclusion criteria
Persons post-stroke who meets any of the following criteria will be excluded
from participation in this study:
• Who are terminally ill.
• Who have severe aphasia; problems with understanding
• Who has been assessed legally incapable by a (geriatric) doctor or
neurologist.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05855226 |
| CCMO | NL81848.029.22 |