Stroke, IschemicSWIFTNCT06709898
Stroke in Working Age and Job Accommodation in Facilitating Transition Back to Work
A study testing Cognitive job accommodation in people with Stroke, Ischemic and Cognitive Impairment, run by Finnish Institute of Occupational Health at 1 site in Finland.
Trial summary
The aim of this randomized controlled trial (RCT) is to investigate whether cognitive job accommodation intervention enhances return to work, work ability and performance after ischemic stroke in working-age population. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Stroke, Ischemic, Cognitive Impairment, Fatigability Post Stroke
- What is being tested?
- Cognitive job accommodation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 10 Jan 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke occurred within 12 month
- At least mild cognitive, emotional and/or state alertness symptoms detected in neuropsychological assessment in subacute phase
- Employed when the stroke occurred and has workplace where to return
- Occupational health services (OHS) available
- Participant has agreed that clinical neuropsychologist and researcher can participate to OHS consultation regarding the job accommodation
- Adequate Finnish language ability to the questionnaires and cognitive tests
Who cannot join
- Work status - professional driver or some other safety critical occupation where even mild cognitive impairments restrict return to work
- Former neurological or psychiatric disorder or developmental disability affecting significantly cognition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nina Nevala, Dr contact
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital Stroke Unit
Helsinki, Uusimaa, 00029
Jukka Putaala, Associate Professor, +358 40 6897703, jukka.putaala@hus.fi
About this study
The aim of this randomized controlled trial (RCT) is to investigate whether cognitive job accommodation intervention enhances return to work, work ability and performance after ischemic stroke in working-age population. The main questions are:
- Does the cognitive job accommodation intervention affect absenteeism and presenteeism after stroke?
- Does the intervention affect work ability and perceived cognitive and emotional difficulties at work?
- Does the intervention decrease mental strain, fatigue and negative mood symptoms after return to work?
- Does the intervention affect life satisfaction among the stroke patients returning to work?
Read more
Researchers will compare the intervention group to a control group returning to work after stroke with current healthcare practices and work procedures.
Participants:
- At baseline, 6 and 12 month follow-up web-based questionnaires and cognitive tests are administered.
- At 3 month follow-up participants fill in Brain Work Questionnaire (BWQ) that measures cognitive demands and difficulties at work.
Read the detailed description
Introduction: Strokes are one of the most significant conditions affecting cognition among working-age adults. Incidence of stroke increases in older age and due to the lengthening of working careers, more people are experiencing strokes while still employed. Additionally, the incidence of strokes among younger workers has increased over recent decades. In Finland, 2000 - 3000 work-aged persons suffer a stroke annually. The majority experiences cognitive or emotional symptoms post-stroke, and for about half of them, these symptoms become long-lasting or permanent. The cognitive demands of modern work have steadily increased, and the severity of cognitive symptoms has been shown to strongly predict the likelihood of returning to work after a stroke. While job accommodation has been shown to be an effective way to support return to work after many illnesses, there is limited research on its benefits following a stroke. Furthermore, there is lack of research on cognitive job accommodation, despite health professionals finding it particularly challenging.
Aims: To evaluate the effect of job accommodations after stroke on various work and health related outcomes. In addition, information about working-aged stroke patients returning to work and the practices of job accommodation is provided. In the future these results can potentially be applied also to other conditions affecting cognition.
Participants and methods: This study will recruit 18-68 year old stroke patients who are returning to work (n ≈ 100). Participants will be randomized into either a job accommodation intervention group or a control group. The study will assess the benefits of cognitive job accommodation in terms of absenteeism, presenteeism, work modifications, perceived work ability, health indicators and cognitive and emotional symptoms. Participants will be followed through web-based surveys and novel cognitive tests over a 12-month period. The study will adopt a multidisciplinary approach (ergonomics, occupational psychology, neuropsychology, and medicine) and will be based on the International Classification of Functioning, Disability, and Health (ICF) model. Cognitive job accommodation will utilize an established model, a design form, and an instructional video.
Collaborators and target organizations: The research will be conducted in collaboration with the Helsinki University Hospital Neurocenter and the Finnish Institute of Occupational Health. In addition to these organizations the study is funded by the Finnish Work Environment Fund. The target organizations include occupational health services and workplaces of stroke survivors.
Utilization of Results: The methods developed in this study can be used in future collaborations between workplaces, occupational health services, and specialized healthcare. The findings can also be applied to other conditions that cause cognitive difficulties and require job accommodation.
- Being tested
- Cognitive job accommodation
- Keywords
- Stroke, Cognitive impairment, Return to work, Job accommodation, Work ability, Neuropsychology
- Medical subject headings
- Ischemic Stroke, Cognitive Dysfunction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive job accommodationOther
Job accommodation focused on the cognitive aspects at work
| Study group | Role | What they receive |
|---|---|---|
| Cognitive job accommodation | Experimental | * In intervention neuropsychological information will be individually processed and transferred systematically from the neurological unit to occupational health service (OHS) to help design the individually tailored work modifications.
* Information of the job accommodation will be given to employers.
* Cognitive job accommodation is carried out at the workplace in cooperation between the employer, employee and OHS.
* Feedback of the cognitively challenging work traits will be given to participants after returning to work. Receives: Other: Cognitive job accommodation |
| Reference group | No intervention | Employees return to work according to standard health care and workplace procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absenteeism and presenteeism
Absenteeism and presenteeism are evaluated with World Health Organization's Health and Work Performance Questionnaire (HPQ) using both absolute and relative measures. Absolute absenteeism: hours in 4 week (higher value indicates worse outcome). Absolute presenteeism: single question measure of own job performance (score 0-10) analyzed according to the HPQ instructions (higher value indicates better outcome). Relative absenteeism: working hours in 4 week / expected working hours in 4 week. Relative presenteeism: evaluation of own job performance (score 0-10) / evaluation of most other workers job performance (score 0-10). This score is restricted to the range of 0.25 to 2.0 according to HPQ instructions. In both relative scores higher values indicate better outcome.
Measured: 6 and 12 months
Work ability
Estimate of the current work ability measured with single question (score range 0-10, higher score indicate better outcome) from Work Ability Index. Estimate of future work ability measured with single question (categorical variable: yes, no, maybe) from Work Ability Index.
Measured: 6 and 12 months
Secondary outcomes (18)
Perceived success in returning to work
Subjectively evaluated success in returning to work. Single item question with 5 point Likert scale (5= very good; 1= very bad).
Measured: 6 and 12 months
Cognitive demands of work and related difficulties
Frequency of different cognitive demands at work and related perceived difficulties measured with Brain Work Questionnaire. Frequency values are reported as averaged occurrence/week (lower values indicate better outcome), and related difficulties in ordinal response variable (0=no difficulties, 1=sometimes difficult, 2=often difficult). Higher value indicates worse outcome.
Measured: 3 and 12 months
Cognitive symptoms at work
Cognitive symptoms at work measured with The Cognitive Function at Work Questionnaire total score (score range 0-58: higher value indicates worse outcome)
Measured: 6 and 12 months
Stress
Estimates of perceived stress. General stress measured with single item stress question (score range 1-5, lower value indicates better outcome). Theme specific stress (at home, work and financial). Ordinal 4 point response scales. Questions from INTERSTROKE study.
Measured: 6 and 12 months
Sick leave days
Number of days on sick leave after returning to work. Higher value indicates worse outcome.
Measured: 6 and 12 months
Insomnia symptoms
Frequency of insomnia symptoms measured with single item question with ordinal 5 point scale (5=Every night or nearly every night; 1=never). Higher value indicates worse outcome.
Measured: 6 and 12 months
Fatigue symptoms
Fatigue symptoms measured with Fatigue Assessment Scale (FAS). Total score range 10-50. Higher score indicates worse outcome.
Measured: 6 and 12 months
Stroke related life satisfaction
Perceived life satisfaction based on the Young Stroke Questionnaire (total score 0-100; where higher score indicates better outcome)
Measured: 6 and 12 months
Mental job strain
Perceived mental job strain. Single item question with ordinal 1-5 point response scale (1=not at all; 5 very much). Higher value indicates worse outcome.
Measured: 6 and 12 months
Perceived cognitive and emotional difficulties in general
Perceived cognitive and emotional difficulties in general measured with Check List for Cognitive and Emotional Consequences. Likert scale questions 0-2. Higher values indicate worse outcome.
Measured: 6 and 12 months
Modified Rankin scale
The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke. The mRS is a 6 point disability scale with possible scores ranging from 0 to 5. Higher score indicates worse outcome.
Measured: 12 months from the stroke
Benefit of the job accommodations
Perceived benefit of the carried out job accommodations. Single item question with 5 point Likert scale (5=very much; 1=very little). Higher value indicates better outcome.
Measured: 6 and 12 months
Job burnout symptoms
Job burnout symptoms measured with Burnout Assessment Tool (BAT) 4-item version. Averaged sum score: range 1-5. Higher score indicates worse outcome.
Measured: 6 and 12 months
Depression symptoms
Depression symptoms measured with Patient health Questionnaire 9 question version (PHQ-9). Total score range 0-27. Higher score indicates worse outcome.
Measured: 6 and 12 months
General life satisfaction
Perceived general life satisfaction measured with single item question with 5 point Likert scale (5=very satisfied; 1=very dissatisfied). Higher score indicates better outcome.
Measured: 6 and 12 months
Daily function ability
Perceived daily ability to function measured with single item question (score range 0-10). Higher score indicates better outcome.
Measured: 6 and 12 months
Amount of job accommodations
Amount of the actualized job accommodations measured with single item question. Ordinal 4 item scale. (3=A lot , 2=somewhat, 1=a little, 0=not at all). Higher value indicates better outcome.
Measured: 6 and 12 months
Work participation
Monthly work participation percentage (%) as compared to fulltime working. Higher value indicate better outcome.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start10 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finnish Institute of Occupational Health
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Finnish Work Environment Fund
- Responsible party
- Sponsor
- Investigators
- Teemu I Paajanen, Dr, Principal investigator, Finnish Institute of Occupational Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709898
- Sponsor's protocol ID
- 4011001
- Acronym
- SWIFT
- Status last verified
- Mar 2025
- First submitted
- 19 Nov 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD not shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke in Working Age and Job Accommodation in Facilitating Transition Back to Work
- ClinicalTrials.gov ID
- NCT06709898
- Acronym / sponsor ID
- SWIFT / 4011001
- Keywords
- Stroke, Cognitive impairment, Return to work, Job accommodation, Work ability, Neuropsychology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Finnish Institute of Occupational HealthUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Finnish Work Environment Fund
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Nov 2024 (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 aim of this randomized controlled trial (RCT) is to investigate whether cognitive job accommodation intervention enhances return to work, work ability and performance after ischemic stroke in working-age population. The main questions are:
- Does the cognitive job accommodation intervention affect absenteeism and presenteeism after stroke?
- Does the intervention affect work ability and perceived cognitive and emotional difficulties at work?
- Does the intervention decrease mental strain, fatigue and negative mood symptoms after return to work?
- Does the intervention affect life satisfaction among the stroke patients returning to work?
Researchers will compare the intervention group to a control group returning to work after stroke with current healthcare practices and work procedures.
Participants:
- At baseline, 6 and 12 month follow-up web-based questionnaires and cognitive tests are administered.
- At 3 month follow-up participants fill in Brain Work Questionnaire (BWQ) that measures cognitive demands and difficulties at work.
Detailed description
Introduction: Strokes are one of the most significant conditions affecting cognition among working-age adults. Incidence of stroke increases in older age and due to the lengthening of working careers, more people are experiencing strokes while still employed. Additionally, the incidence of strokes among younger workers has increased over recent decades. In Finland, 2000 - 3000 work-aged persons suffer a stroke annually. The majority experiences cognitive or emotional symptoms post-stroke, and for about half of them, these symptoms become long-lasting or permanent. The cognitive demands of modern work have steadily increased, and the severity of cognitive symptoms has been shown to strongly predict the likelihood of returning to work after a stroke. While job accommodation has been shown to be an effective way to support return to work after many illnesses, there is limited research on its benefits following a stroke. Furthermore, there is lack of research on cognitive job accommodation, despite health professionals finding it particularly challenging.
Aims: To evaluate the effect of job accommodations after stroke on various work and health related outcomes. In addition, information about working-aged stroke patients returning to work and the practices of job accommodation is provided. In the future these results can potentially be applied also to other conditions affecting cognition.
Participants and methods: This study will recruit 18-68 year old stroke patients who are returning to work (n ≈ 100). Participants will be randomized into either a job accommodation intervention group or a control group. The study will assess the benefits of cognitive job accommodation in terms of absenteeism, presenteeism, work modifications, perceived work ability, health indicators and cognitive and emotional symptoms. Participants will be followed through web-based surveys and novel cognitive tests over a 12-month period. The study will adopt a multidisciplinary approach (ergonomics, occupational psychology, neuropsychology, and medicine) and will be based on the International Classification of Functioning, Disability, and Health (ICF) model. Cognitive job accommodation will utilize an established model, a design form, and an instructional video.
Collaborators and target organizations: The research will be conducted in collaboration with the Helsinki University Hospital Neurocenter and the Finnish Institute of Occupational Health. In addition to these organizations the study is funded by the Finnish Work Environment Fund. The target organizations include occupational health services and workplaces of stroke survivors.
Utilization of Results: The methods developed in this study can be used in future collaborations between workplaces, occupational health services, and specialized healthcare. The findings can also be applied to other conditions that cause cognitive difficulties and require job accommodation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Cognitive job accommodation | Experimental | Other: Cognitive job accommodation* In intervention neuropsychological information will be individually processed and transferred systematically from the neurological unit to occupational health service (OHS) to help design the individually tailored work modifications. * Information of the job accommodation will be given to employers. * Cognitive job accommodation is carried out at the workplace in cooperation between the employer, employee and OHS. * Feedback of the cognitively challenging work traits will be given to participants after returning to work. |
| Reference group | No intervention | –Employees return to work according to standard health care and workplace procedures. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ischemic stroke occurred within 12 month
- At least mild cognitive, emotional and/or state alertness symptoms detected in neuropsychological assessment in subacute phase
- Employed when the stroke occurred and has workplace where to return
- Occupational health services (OHS) available
- Participant has agreed that clinical neuropsychologist and researcher can participate to OHS consultation regarding the job accommodation
Key exclusion criteria (2 listed)
- Work status - professional driver or some other safety critical occupation where even mild cognitive impairments restrict return to work
- Former neurological or psychiatric disorder or developmental disability affecting significantly cognition
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 |
|---|---|---|
| Cognitive job accommodationJob accommodation focused on the cognitive aspects at work | Other | Cognitive job accommodation |
Primary outcome
Absenteeism and presenteeism
Time frame: 6 and 12 months
Absenteeism and presenteeism are evaluated with World Health Organization's Health and Work Performance Questionnaire (HPQ) using both absolute and relative measures. Absolute absenteeism: hours in 4 week (higher value indicates worse outcome). Absolute presenteeism: single question measure of own job performance (score 0-10) analyzed according to the HPQ instructions (higher value indicates better outcome). Relative absenteeism: working hours in 4 week / expected working hours in 4 week. Relative presenteeism: evaluation of own job performance (score 0-10) / evaluation of most other workers job performance (score 0-10). This score is restricted to the range of 0.25 to 2.0 according to HPQ instructions. In both relative scores higher values indicate better outcome.
Work ability
Time frame: 6 and 12 months
Estimate of the current work ability measured with single question (score range 0-10, higher score indicate better outcome) from Work Ability Index. Estimate of future work ability measured with single question (categorical variable: yes, no, maybe) from Work Ability Index.
18 secondary outcomes
Perceived success in returning to work
Time frame: 6 and 12 months
Cognitive demands of work and related difficulties
Time frame: 3 and 12 months
Cognitive symptoms at work
Time frame: 6 and 12 months
Stress
Time frame: 6 and 12 months
Sick leave days
Time frame: 6 and 12 months
Insomnia symptoms
Time frame: 6 and 12 months
Fatigue symptoms
Time frame: 6 and 12 months
Stroke related life satisfaction
Time frame: 6 and 12 months
Mental job strain
Time frame: 6 and 12 months
Perceived cognitive and emotional difficulties in general
Time frame: 6 and 12 months
Modified Rankin scale
Time frame: 12 months from the stroke
Benefit of the job accommodations
Time frame: 6 and 12 months
Job burnout symptoms
Time frame: 6 and 12 months
Depression symptoms
Time frame: 6 and 12 months
General life satisfaction
Time frame: 6 and 12 months
Daily function ability
Time frame: 6 and 12 months
Amount of job accommodations
Time frame: 6 and 12 months
Work participation
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No. IPD not shared
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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.
Nina Nevala, Dr contact
Teemu I Paajanen, Dr principal investigator
Finnish Institute of Occupational Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive job accommodation in people with Stroke, Ischemic and Cognitive Impairment, run by Finnish Institute of Occupational Health at 1 site in Finland.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teemu I Paajanen, Dr (+358438250389, teemu.paajanen@ttl.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absenteeism and presenteeism (time frame: 6 and 12 months). 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 13 Mar 2025.