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NCT Number: NCT07264387

Predictive Factors for Return to Work After a First Stroke Treated at Clermont-Ferrand University Hospital in Puy de Dôme Between January 2020 and December 2024

Stroke is a leading cause of acquired motor disability and the second most common cause of major cognitive impairment worldwide. In France, approximately 150,000 new cases occur annually, with around 31% affecting individuals of working age, making return to work (RTW) a critical public health issue. Beyond the medical burden, stroke has profound socio-economic consequences, including loss of productivity, prolonged sick leave, part-time resumption, and the need for workplace adaptations. While RTW after stroke has been investigated, major gaps remain. No standardized recommendations exist for vocational reintegration, and predictive factors are still debated. Quantitative determinants such as stroke type, severity, functional independence, and occupational characteristics have been identified, but qualitative aspects-including self-efficacy, perceived social burden, employer relationships, and motivation-are poorly documented. Moreover, cognitive deficits are often insufficiently characterized, as screening tools such as MMSE or MoCA lack the sensitivity of comprehensive neuropsychological assessments. The impact of revascularization procedures on RTW and the ability to sustain employment after initial resumption also remain unclear. Importantly, no recent data are available in the Auvergne region, despite evolving labor policies that may influence reintegration trajectories. This observational study therefore aims to identify both quantitative and qualitative predictors of RTW after ischemic or hemorrhagic stroke, describe vocational pathways in a regional cohort, and explore barriers and facilitators to long-term reintegration. Ultimately, the study seeks to provide updated evidence to guide tailored rehabilitation and socio-professional reintegration strategies, supporting sustainable RTW in working-age stroke survivors.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clermont Ferrand University Hospital, Louise Michel site, Cébazat, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have suffered an ischaemic stroke according to ICD-10 (ICD-10 code: I63 (cerebral infarction) I64 (unspecified stroke), I69 (sequelae of cerebrovascular disease) or patients who have had a haemorrhagic stroke according to ICD-10 (ICD-10 code: I60, I61 and I62) between January 2020 and March 2024
  • Patients of working age/under 64 years of age (legal retirement age)
  • Patients with an employment contract at the time of the stroke
  • Patients treated at Clermont-Ferrand University Hospital
  • Post-stroke consultation recorded in the patient's medical file
  • Patients affiliated with the social security system
  • Patients who have not objected to participating in the study

Exclusion criteria

  • Patients with a history of ischaemic or haemorrhagic stroke
  • Patients with a history of head trauma with neurological sequelae corresponding to codes S060, S061, S062, S063, S065, S066, S067, S068 and S069
  • Patients who died as a result of stroke
  • Patients unable to respond to telephone questionnaires
  • Patients under guardianship or trusteeship
  • Patients who have suffered a transient ischaemic attack (TIA) (G459 according to ICD 10)
  • Patients who were in early retirement at the time of assessment
  • No information on employment after stroke in the medical file
  • Patients with category 2 or 3 disability prior to stroke due to another condition
  • Patients on sick leave prior to stroke due to another condition
  • Patients receiving RSA income support

Treatment and study plan

Primary outcomes

  1. Return to work rate

    Time frame: At inclusion

    Percentage of return to work after a first ischaemic or haemorrhagic stroke between January 2020 and December 2024 in patients of working age.

  2. Factors correlated with return to work

    Time frame: At inclusion

    Determine the factors associated with return to work (gender)

  3. Factors correlated with return to work

    Time frame: At inclusion

    Determine the factors associated with return to work (stroke severity)

  4. Factors correlated with return to work

    Time frame: At inclusion

    Determine the factors associated with return to work (stroke type (ischaemic or haemorrhagic)).

  5. Factors correlated with return to work

    Time frame: At inclusion

    Determine the factors associated with return to work (independence)

  6. Factors correlated with return to work

    Time frame: At inclusion

    Determine the factors associated with return to work (occupation)

Secondary outcomes

  1. Quality of life after stroke

    Time frame: At inclusion

    The Short-Form-12 (SF-12) questionnaire is a standardized self-administered questionnaire used to assess health-related quality of life. It comprises 12 questions covering 8 domains: physical activities, physical and mental limitations, pain, perceived general health, vitality, mental health and social relationships. Each item is rated on a 5- or 6-point Likert scale. The responses are used to calculate two scores: a physical composite score (PCS) and a mental composite score (MCS), each ranging from 0 (perceived health status very poor) to 100 (perceived health status optimal).

  2. Anxiety and Depression scale

    Time frame: At inclusion

    The Hospital Anxiety and Depression Scale (HADs) questionnaire is a psychometric self-assessment questionnaire consisting of 14 items divided into two subscales (anxiety and depression) of seven items each. Each item is rated on a scale of 0 to 3. A score is given for each subscale, A for anxiety and D for depression. The score can range from 0 (no anxiety and/or depressive disorders) to 21 (proven anxiety and/or depressive disorders of varying severity) for each subscale.

  3. Fatigue Severity Scale

    Time frame: At inclusion

    The Fatigue Severity Scale (FSS) questionnaire is a self-assessment tool used to evaluate the severity of fatigue and its impact on daily activities. This questionnaire consists of nine items rated on a seven-point Likert scale, ranging from 1 ('strongly disagree') to 7 ('strongly agree'). The score ranges from 7 (no fatigue in daily activities) to 63 (extreme fatigue in daily activities). A score above 36 indicates that the patient may need to have their fatigue assessed by a healthcare professional.

  4. Predictive score for return-to-work rate

    Time frame: At inclusion

    Develop a predictive score for return to work using the predictive factors for return to work identified in the main objective.

  5. Job retention

    Time frame: At inclusion

    To study job retention and its association with factors such as stroke severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

+33473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: RTWS2

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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