StrokeOTHERNCT05855226
Effect of Occupational Therapy at Home E-Rehabilitation (OTHER) for Persons Post-stroke
A study testing OTHER-intervention (Occupational Therapy at Home E-Rehabilitation) in people with Stroke and eHealth, run by Amsterdam University of Applied Sciences at 9 sites in Netherlands.
Trial summary
The goal of this (cost)effectiveness study is to compare care as usual with OTHER-intervention in Cerebro Vascular Accident (CVA) older adults in Geriatric Rehabilitation (GR). The main question[s] it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Stroke, eHealth, Occupational Therapy
- What is being tested?
- OTHER-intervention (Occupational Therapy at Home E-Rehabilitation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 9 sitesNetherlands
- Study dates
- 13 Mar 2023to 20 Mar 2026
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 at home
Who cannot join
- Who are terminally ill
- Who have severe aphasia; problems with understanding.
- Who has been assessed legally incapable by a geriatric doctor
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Netherlands9 sites
Hogeschool van Amsterdam
Amsterdam-Zuidoost, North Holland, 1105 BD
TanteLouise
Bergen op Zoom, North Brabant, 4613 AK
Cicero Zorggroep
Brunssum, Limburg, 6441 CR
ZZG Herstelcentrum
Groesbeek, Gerlderland, 6561 LE
Sevagram
Heerlen, Limburg, 6419 PB
GRZ Plus (2 locations, Omring and Zorgcirkel)
Hoorn, North Holland, 1624 AB
Vivium Naardenheem
Naarden, North Holland, 1411 HB
Behandelcentrum SZR
Tiel, Gelderland, 4003 CA
AxionContinu
Utrecht, Utrecht, 3526KJ
About this study
Official title: Supporting Daily Functioning of Persons With a Neurological Disorder: (Cost)Effectiveness of Occupational Therapy at Home E-Rehabilitation (OTHER) for Persons Post-stroke
The goal of this (cost)effectiveness study is to compare care as usual with OTHER-intervention in Cerebro Vascular Accident (CVA) older adults in Geriatric Rehabilitation (GR). The main question[s] it aims to answer are:
- What is the effectiveness of OTHER, as compared to occupational therapy as usual (CAU), 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, 13 and 26)? Secondary:
- What is the effectiveness of OTHER on improving satisfaction with the perceived daily performance of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach)
- What is the effectiveness of OTHER on improving physical activity of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach)
- What is the effectiveness of OTHER on improving self-management of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach)
- How do persons post-stroke and OT's experience and how do they reflect on OTHER in supporting a sense of self-management, safety and improving daily functioning? (qualitative approach).
- What factors influenced the intervention delivery and the perceived benefits in the OTHER study (process evaluation)? 1) monitoring treatment fidelity, barriers and facilitators for implementation; 2) gain insight into the impact of OTHER on the GR transition to home; 3) to gain insight into what stroke survivors and OT's think of OTHER. 4) how participants, and professionals experience and thoughts they have on the OTHER-intervention in supporting daily functioning and self-management Cost-effectiveness
- What is the cost-effectiveness of OTHER on improving self-perceived performance in daily activities and Quality Adjusted Life Years (QALYs) of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach)
Read more
Participants will get the OTHER-intervention treatment given by de occupational therapist which consists of activity monitoring, coaching and videoconferencing to optimalise the transition from clinical care to home.
Researchers will compare care as usual to see if there is a effect on improving the self-perceived performance in daily activities, self-management and improving physical activity .
- Conditions
- Stroke, eHealth, Occupational Therapy
- Being tested
- OTHER-intervention (Occupational Therapy at Home E-Rehabilitation)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTHER-intervention (Occupational Therapy at Home E-Rehabilitation)Other
The occupational therapist will use activity monitoring and coaching techniques with videoconference during OTHER.
| Study group | Role | What they receive |
|---|---|---|
| Care as usual | No intervention | Care as usual, consist of GR rehabilitation when a patient is back at home. |
| OTHER-intervention | Experimental | The OTHER-intervention is part of the OT care. Start during inpatient GR rehabilitation and goes on 12 weeks after discharge when a patient is home or starts after discharge from hospital going home. The OT will coach a patient and use a activity monitoring system. Also videoconferencing will be used. Receives: Other: OTHER-intervention (Occupational Therapy at Home E-Rehabilitation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Canadian Occupational Performance measure (COPM-p) at three time points
The primary outcome measure is 'perceived daily performance' 4 weeks, 12 weeks and 24 weeks after the start of OTHER compared to baseline functioning, measured with the Canadian Occupational Performance measure. The COPM results in a performance score (COPM-p). The COPM is a person-centred, occupation-focused outcome measure for the detection of change in perceived daily performance over time. The COPM results in a performance score (COPM-p) and a satisfaction score (COPM-s). Through a semi-structured interview, persons will prioritize up to five daily activities that deemed most important and rate each on a 10-point scale regarding perceived performance (COPM-p) (1=not able to do at all and 10 = able to do extremely well. The mean COPM-p will be obtained by summing the ratings and dividing them by the number of prioritized activities.
Measured: The investigators assess the changes across three time points (one, three and six months)
Secondary outcomes (8)
Changes in Canadian Occupational Performance measure (COPM-s)
Persons post-stroke satisfaction in performing daily functioning will be measured with the COPM-s(35). Next to the COPM-p, participants rated the prioritized daily activities on a 10-point scale regarding performance satisfaction (COPM-s) (1= not satisfied at all and 10= extremely satisfied).
Measured: baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Self-management
Self-management. The Patient-Reported Outcome Occupational Therapy (PROM-OT) is developed to measure the outcome and quality of OT in the Netherlands from a client perspective.The PROM-OT contains 13 questions regarding the outcome of OT for the person (e.g. I can perform my daily activities, whether or not with help/devices (for example self-care, household, leisure, work) and using scoring with 11 point scale (0= lowest score and 10 = highest score). It focusses on daily activities, being able to self-manage related to daily functioning and satisfaction of OT.
Measured: baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Patient's quality of life.
The EuroQol-5D-5L(41) will be used to measure 'health-related quality of life' outcomes (HRQOL).The HRQOL is measured on 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each health dimension has 5 severity levels ranging between no problems to extreme problems. The EQ- visual analogue scale (VAS) measures the persons' self-rated health on a scale from 0 to 100 (0= worst health and 100 the best health). The participants' EQ-5D-5L health states will be converted into utility values the Dutch tariff.
Measured: baseline,4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Capability of older people
The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. Unlike most profile measures used in economic evaluations, the ICECAP-O focuses on wellbeing defined in a broader sense, rather than health. The measure covers attributes of wellbeing that were found to be important to older people in the United Kingdom. ICECAP-O comprises five attributes (the lay terms are in brackets): Attachment (love and friendship), Security (thinking about the future without concern), Role (doing things that make participants feel valued), Enjoyment (enjoyment and pleasure), Control (independence). Score from 1 till 4 (1 = lowest and 4 = highest score
Measured: baseline,4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Activity level
The wearable activity monitor (PAM) will be applied to measure the amount of active movement in minutes per day.
Measured: up to 15 weeks
Mobility functioning
Time up and go test is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old) an persons with stroke.
Measured: baseline and 24 weeks after discharge GR
Satisfaction with OT
The Patient-Reported Outcome Measure - Occupational Therapy (PROM-OT) is developed to measure the outcome and quality of OT in the Netherlands from a client perspective. The PROM-OT contains 13 questions regarding the outcome of OT for the person (e.g. I can perform my daily activities, whether or not with help/devices (for example self-care, household, leisure, work) and using scoring with 11 point scale (0= lowest score and 10 = highest score). It focusses on daily activities, being able to self-manage related to daily functioning and satisfaction of OT.
Measured: baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Societal cost
Costs will be measured from a societal perspective, meaning that all costs related to the intervention will be measured, irrespective of who pays or benefits from them. Cost will be measured using retrospective cost questionnaires administered after 12 weeks and 24 weeks.
Measured: 12 weeks after discharge GR and 24 weeks after discharge GR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start13 Mar 2023
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Amsterdam UMC
- Responsible party
- Principal investigator, Sanne Pellegrom, Amsterdam University of Applied Sciences
- Investigators
- Margo van Hartingsveldt, Dr., Study director, Amsterdam University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855226
- Sponsor's protocol ID
- 80-86900-98-022
- Acronym
- OTHER
- Status last verified
- Jul 2026
- First submitted
- 30 Mar 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Daily Functioning of Persons With a Neurological Disorder: (Cost)Effectiveness of Occupational Therapy at Home E-Rehabilitation (OTHER) for Persons Post-stroke
- ClinicalTrials.gov ID
- NCT05855226
- Acronym / sponsor ID
- OTHER / 80-86900-98-022
- Conditions
- Stroke, eHealth, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Amsterdam University of Applied SciencesUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Amsterdam UMC
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 11 May 2023 (actual)
- 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 goal of this (cost)effectiveness study is to compare care as usual with OTHER-intervention in Cerebro Vascular Accident (CVA) older adults in Geriatric Rehabilitation (GR). The main question[s] it aims to answer are:
- What is the effectiveness of OTHER, as compared to occupational therapy as usual (CAU), 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, 13 and 26)? Secondary:
- What is the effectiveness of OTHER on improving satisfaction with the perceived daily performance of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach)
- What is the effectiveness of OTHER on improving physical activity of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach)
- What is the effectiveness of OTHER on improving self-management of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach)
- How do persons post-stroke and OT's experience and how do they reflect on OTHER in supporting a sense of self-management, safety and improving daily functioning? (qualitative approach).
- What factors influenced the intervention delivery and the perceived benefits in the OTHER study (process evaluation)? 1) monitoring treatment fidelity, barriers and facilitators for implementation; 2) gain insight into the impact of OTHER on the GR transition to home; 3) to gain insight into what stroke survivors and OT's think of OTHER. 4) how participants, and professionals experience and thoughts they have on the OTHER-intervention in supporting daily functioning and self-management Cost-effectiveness
- What is the cost-effectiveness of OTHER on improving self-perceived performance in daily activities and Quality Adjusted Life Years (QALYs) of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach)
Participants will get the OTHER-intervention treatment given by de occupational therapist which consists of activity monitoring, coaching and videoconferencing to optimalise the transition from clinical care to home.
Researchers will compare care as usual to see if there is a effect on improving the self-perceived performance in daily activities, self-management and improving physical activity .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care as usual | No intervention | –Care as usual, consist of GR rehabilitation when a patient is back at home. |
| OTHER-intervention | Experimental | Other: OTHER-intervention (Occupational Therapy at Home E-Rehabilitation)The OTHER-intervention is part of the OT care. Start during inpatient GR rehabilitation and goes on 12 weeks after discharge when a patient is home or starts after discharge from hospital going home. The OT will coach a patient and use a activity monitoring system. Also videoconferencing will be used. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 at home
Key exclusion criteria (3 listed)
- Who are terminally ill
- Who have severe aphasia; problems with understanding.
- Who has been assessed legally incapable by a geriatric doctor
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 |
|---|---|---|
| OTHER-intervention (Occupational Therapy at Home E-Rehabilitation)The occupational therapist will use activity monitoring and coaching techniques with videoconference during OTHER. | Other | OTHER-intervention |
Primary outcome
Changes in Canadian Occupational Performance measure (COPM-p) at three time points
Time frame: The investigators assess the changes across three time points (one, three and six months)
The primary outcome measure is 'perceived daily performance' 4 weeks, 12 weeks and 24 weeks after the start of OTHER compared to baseline functioning, measured with the Canadian Occupational Performance measure. The COPM results in a performance score (COPM-p). The COPM is a person-centred, occupation-focused outcome measure for the detection of change in perceived daily performance over time. The COPM results in a performance score (COPM-p) and a satisfaction score (COPM-s). Through a semi-structured interview, persons will prioritize up to five daily activities that deemed most important and rate each on a 10-point scale regarding perceived performance (COPM-p) (1=not able to do at all and 10 = able to do extremely well. The mean COPM-p will be obtained by summing the ratings and dividing them by the number of prioritized activities.
8 secondary outcomes
Changes in Canadian Occupational Performance measure (COPM-s)
Time frame: baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Self-management
Time frame: baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Patient's quality of life.
Time frame: baseline,4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Capability of older people
Time frame: baseline,4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Activity level
Time frame: up to 15 weeks
Mobility functioning
Time frame: baseline and 24 weeks after discharge GR
Satisfaction with OT
Time frame: baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Societal cost
Time frame: 12 weeks after discharge GR and 24 weeks after discharge GR
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 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
RecruitingObservational study
Natural History of Stroke: Cause and Development
Brain Disease, Ischemic Attack, Transient
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
Active, not recruitingPhase 3
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Intracranial Arteriosclerosis, Stroke
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
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.
Margo van Hartingsveldt, Dr. study director
Amsterdam University of Applied Sciences
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTHER-intervention (Occupational Therapy at Home E-Rehabilitation) in people with Stroke and eHealth, run by Amsterdam University of Applied Sciences at 9 sites in Netherlands.
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 3 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands. 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.
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?
Changes in Canadian Occupational Performance measure (COPM-p) at three time points (time frame: The investigators assess the changes across three time points (one, three and six months)). 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 9 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.