Clinical trial NCT06709898: Stroke in Working Age and Job Accommodation in Facilitating Transition Back to Work
Official title: Stroke in Working Age and Job Accommodation in Facilitating Transition Back to Work
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Ischemic
Cognitive Impairment
Fatigability Post Stroke
Mood Disturbances
Keywords: Stroke
Cognitive impairment
Return to work
Job accommodation
Work ability
Neuropsychology
Lead sponsor: Finnish Institute of Occupational Health
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Finnish Work Environment Fund
First posted: 2024-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Absenteeism and presenteeism
timeFrame: 6 and 12 months
measure: Work ability
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Perceived success in returning to work
timeFrame: 6 and 12 months
measure: Cognitive demands of work and related difficulties
timeFrame: 3 and 12 months
measure: Cognitive symptoms at work
timeFrame: 6 and 12 months
measure: Stress
timeFrame: 6 and 12 months
measure: Sick leave days
timeFrame: 6 and 12 months
measure: Insomnia symptoms
timeFrame: 6 and 12 months
measure: Fatigue symptoms
timeFrame: 6 and 12 months
measure: Stroke related life satisfaction
timeFrame: 6 and 12 months
measure: Mental job strain
timeFrame: 6 and 12 months
measure: Perceived cognitive and emotional difficulties in general
timeFrame: 6 and 12 months
measure: Modified Rankin scale
timeFrame: 12 months from the stroke
measure: Benefit of the job accommodations
timeFrame: 6 and 12 months
measure: Job burnout symptoms
timeFrame: 6 and 12 months
measure: Depression symptoms
timeFrame: 6 and 12 months
measure: General life satisfaction
timeFrame: 6 and 12 months
measure: Daily function ability
timeFrame: 6 and 12 months
measure: Amount of job accommodations
timeFrame: 6 and 12 months
measure: Work participation
timeFrame: 6 and 12 months
Other outcomes:
measure: Cognitive test performance
timeFrame: 6 and 12 months
measure: Level of social support
timeFrame: 6 and 12 months
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital Stroke Unit
state: Uusimaa
Study officials:
affiliation: Finnish Institute of Occupational Health
name: Teemu I Paajanen, Dr
role: PRINCIPAL_INVESTIGATOR
References: