The Effectiveness of a Functional Capacity Evaluation Among Persons on Sick Leave or Work Disability

NCT06158464 | Unknown

• 1 other identifier: FCE-study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Sick Leave; Absenteeism; Return to Work

Keywords

return-to-work; functional capacity evaluation; randomized controlled trial; workability; occupational therapy

Outcome Measures

Primary Outcomes (1)

• Workability

  The single-item first WAI (Work Ability Index) question is a self-report question in which the person rates his "current work ability compared with the lifetime best", with a score of 0 ("completely unable to work") up to 10 ("work ability at its lifetime best").

  measured at baseline, and 3, 6 and 9 months post baseline

Secondary Outcomes (6)

• Self-efficacy in the context of return-to-work

  measured at baseline, and 3, 6 and 9 months post baseline

• Expectations to return-to-work

  measured at baseline, and 3, 6 and 9 months post baseline

• Steps to return-to-work

  measured at baseline, and 3, 6 and 9 months post baseline

• Pain scale

  measured at baseline, and 3, 6 and 9 months post baseline

• Illness perception

  measured at baseline, and 3, 6 and 9 months post baseline

Study Arms (2)

Care-as-usual

NO INTERVENTION

In standard care, persons on sick leave/work disability are invited by the medical advisor for a consultation. If the patient is allocated to the control group (or if the patient did not agree to participate in the study), the medical advisor takes decisions based on the information at his disposal, e.g. start a return-to-work trajectory, to temporarily prolong sickness absence and disability, or to confirm definitive work disability. If they agree to participate, they are asked to complete four questionnaires: at baseline, at 3 months, 6 months, and 9 months.

Care-as-usual supplemented by a Functional Capacity Evaluation

EXPERIMENTAL

In the intervention group, participants are referred to an occupational therapist to receive an FCE. Afterwards, the occupational therapist completes a standardized FCE-template, and conveys these recommendations to the medical advisor. This template includes a list of ICF categories important to the work context. The conclusion of the FCE includes: 1) The facilitators and barriers related to work-related physical, cognitive or psychological functioning, or related to environmental and/or psychosocial factors. 2) A recommendation on the current or last occupation or a reference occupation with or without adaptation and/or on reorientation, training, coaching. Based on the FCE results, the medical advisor can adapt his advice and communicate to the person on sick leave/work disability to advise him/her, or refer the person on sick leave/work disability to other partners (such as VDAB, FOREM, Actiris, or the RTW-coordinator).

Other: Functional Capacity Evaluation

Interventions

Functional Capacity Evaluation OTHER

In a FCE, an occupational therapist will evaluate a patient's ability to perform work-related tasks, using a battery of tests. Depending on the circumstances, he/she will for instance test fatigue, ask the patient to kneel, lift objects, or assess concentration. This assessment lasts ± 4 hours and includes physical tests and tests related to the (previous or reference) profession of the client. This means that an explicit match is made between the functional capacities of the patient (what is he/she capable of) and the demands of a certain job (what is he/she expected to do). Following this assessment, the occupational therapist will explain the results of this assessment to the patient. The evaluation will therefore take place during one or two visits.

Care-as-usual supplemented by a Functional Capacity Evaluation

Eligibility Criteria

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

You may qualify if:

• 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.
• The person on sick leave/work disability is of working age (18-65).

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead
• Haute École Léonard de Vinci: collaborator
• National Institute for Health and Disability Insurance (NIHDI), Belgium: collaborator

Study Sites (8)

MC Hainaut

Anderlues, Belgium

RECRUITING

LM Plus Antwerpen

Antwerp, Belgium

RECRUITING

Helan/Medisch kabinet Genk

Genk, Belgium

RECRUITING

CM Gent

Ghent, Belgium

RECRUITING

CM Vlaams-Brabant

Leuven, Belgium

RECRUITING

MC Liège

Liège, Belgium

RECRUITING

CM Oostende

Ostend, Belgium

RECRUITING

Mutsoc Luxembourg

Saint-Hubert, Belgium

RECRUITING

Central Study Contacts

Jonas S Steel, PhD

CONTACT

+3216373079; jonas.steel@kuleuven.be

Julie Paradis, PhD

CONTACT

+3227934444; julie.paradis@vinci.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr. (MD)

Model Details: A randomised controlled trial will be set up (RCT). For this purpose, 10 consulting physicians, 30 occupational therapists, and 200 persons on incapacity will be recruited. Then, persons on sick leave/work disability are randomly divided into two groups: 1) Persons in the control group receive care-as-usual without modifications. 2) Persons in the intervention group receive usual care and a functional capacity evaluation (FCE). Both groups are asked to complete questionnaires at baseline, and after 3,6, and 9 months. Primary outcome is the difference in workability at 6 months follow-up.

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: September 14, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: starting december 2024
• Access Criteria: pseudonymized raw data

Locations

BE (8)