Stroke in Working Age and Job Accommodation in Facilitating Transition Back to Work

NCT06709898 | Recruiting

• 1 other identifier: 4011001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Cognitive Impairment; Fatigability Post Stroke; Mood Disturbances

Keywords

Stroke; Cognitive impairment; Return to work; Job accommodation; Work ability; Neuropsychology

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 and 12 months

Secondary Outcomes (18)

• Perceived success in returning to work

  6 and 12 months

• Cognitive demands of work and related difficulties

  3 and 12 months

• Cognitive symptoms at work

  6 and 12 months

• Stress

  6 and 12 months

• Sick leave days

  6 and 12 months

Other Outcomes (2)

• Cognitive test performance

  6 and 12 months

• Level of social support

  6 and 12 months

Study Arms (2)

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.

Other: Cognitive job accommodation

Reference group

NO INTERVENTION

Employees return to work according to standard health care and workplace procedures.

Interventions

Cognitive job accommodation OTHER

Job accommodation focused on the cognitive aspects at work

Cognitive job accommodation

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Finnish Institute of Occupational Health: lead
• Helsinki University Central Hospital: collaborator
• Finnish Work Environment Fund: collaborator

Study Sites (1)

Helsinki University Hospital Stroke Unit

Helsinki, Uusimaa, 00029, Finland

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Cognitive Dysfunction; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Teemu I Paajanen, Dr

  Finnish Institute of Occupational Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teemu I Paajanen, Dr

CONTACT

+358438250389; teemu.paajanen@ttl.fi

Nina Nevala, Dr

CONTACT

nina.nevala@ttl.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 29, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)