Evaluating Functional Capacity for People on Sick Leave
The Effectiveness of a Functional Capacity Evaluation (FCE) on the Return-to-work Process in Belgium: a Randomized Controlled Trial
This study tests if adding a Functional Capacity Evaluation to regular care can help people on sick leave in Belgium get back to work more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 8 sites (Anderlues and 7 other locations) |
| Trial ID | NCT06158464 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of Functional Capacity Evaluations (FCE) for individuals on sick leave or work disability in Belgium. It involves a randomized controlled trial where participants in the intervention group receive an FCE in addition to standard care, while the control group receives only standard care. The study will evaluate the quantitative impact of FCE on participants and the qualitative effects on decision-making by medical advisors. Questionnaires will be administered at baseline and at 3, 6, and 9 months to gather comprehensive data on outcomes.
Who should consider this trial
Good fit: Ideal candidates are Belgian citizens aged 18-65 on sick leave or work disability due to stabilized medical conditions that are not primarily mental or psychiatric disorders.
Not a fit: Patients with ongoing workplace injury claims or those whose medical conditions are not stabilized may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the return-to-work process for individuals on sick leave by providing clearer insights into their functional capabilities.
How similar studies have performed: Other studies have shown promise in using functional evaluations to aid return-to-work decisions, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * persons on sick leave or work disability (according to Belgian law) * The person on sick leave/work disability is affected by an illness/injury that is considered stabilized (no significant medical evolution of the disease, nor a medical procedure or acute treatment is expected). * The illness/injury of the person on sick leave/work disability is not mainly a mental/psychiatric disorder. * From the point of view of the medical advisor, there is a lack of consistent information on the person on sick leave/work disability's capacity to return-to-work. * Inclusion takes place from the 6th month of incapacity for work. * The person on sick leave/work disability is of working age (18-65). Exclusion Criteria: * In the case of an accident at workplace, the medical condition of the person on sick leave/work disability has not yet been declared consolidated, meaning that the condition does not progress significantly, either naturally or with treatment. * The medical advisor of the mutual health insurance is expecting in the near future: 1) a spontaneous return to work (total or partial), 2) a registration as a job-seeker, or 3) an end of the recognition of the work disability. * The person on sick leave/work disability is pregnant. * The medical advisor of the mutual health insurance perceives the person on sick leave/work disability does not have sufficient work capacity.
Where this trial is running
Anderlues and 7 other locations
- MC Hainaut — Anderlues, Belgium (Recruiting)
- LM Plus Antwerpen — Antwerp, Belgium (Recruiting)
- Helan/Medisch kabinet Genk — Genk, Belgium (Recruiting)
- CM Gent — Gent, Belgium (Recruiting)
- CM Vlaams-Brabant — Leuven, Belgium (Recruiting)
- MC Liège — Liège, Belgium (Recruiting)
- CM Oostende — Oostende, Belgium (Recruiting)
- Mutsoc Luxembourg — Saint-Hubert, Belgium (Recruiting)
Study contacts
- Study coordinator: Jonas S Steel, PhD
- Email: jonas.steel@kuleuven.be
- Phone: +3216373079
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.