The Effectiveness of a Functional Capacity Evaluation Among Persons on Sick Leave or Work Disability (NCT06158464) | Clinical Trial Compass
UnknownNot Applicable
The Effectiveness of a Functional Capacity Evaluation Among Persons on Sick Leave or Work Disability
Belgium200 participantsStarted 2023-09-14
Plain-language summary
The goal of this clinical trial is to evaluate Functional Capacity Evaluations in persons on sick leave or work disability. The main questions it aims to answer are:
* What is the impact of FCE on the person on sick leave/work disability (quantitative)
* What is the impact of FCE on the decision-making process by the medical advisor? (qualitative)
* What is the usability, feasibility and quality of FCE for the medical advisor, occupational therapist, mediators of the regional services, and return-to-work coordinators? (qualitative)
This is a randomized controlled trial (RCT). Participants in the control group will receive care-as-usual by the medical advisor. Participants in the intervention group will receive an FCE on top of care-as-usual. This is performed by an occupational therapist in their region, and a report of the FCE is delivered to the medical advisor. Both groups are asked to complete questionnaires at baseline, and after 3,6, and 9 months.
Researchers will compare questionnaire results from participants in the control and intervention group, to see if their workability (primary outcome), steps to return to work, expectations to return to work, return to work beliefs, time until (partial) reintegration, self-efficacy in return to work, pain scale, and illness perception (secondary outcomes) are affected differently.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Workability
Timeframe: measured at baseline, and 3, 6 and 9 months post baseline