Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06158464
Status:
RECRUITING
Last Update Posted:
2024-01-29
First Post:
2023-11-28
Brief Title:
The Effectiveness of a Functional Capacity Evaluation Among Persons on Sick Leave or Work Disability
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
Official Title:
The Effectiveness of a Functional Capacity Evaluation FCE on the Return-to-work Process in Belgium a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FCE
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 leavework 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 36 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
What is the impact of FCE on the person on sick leavework 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 36 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
Detailed Description:
This research project on the use of Functional Capacity Evaluations FCE within the context of benefit insurance in Belgium falls under the joint control of the National Institute for Sickness and Disability Insurance RIZIV the Haute École de Leonard Vinci and KU Leuven KU Leuven hereby acts as the studys principal but together with RIZIV and Haute École determines the objectives of the study as joint controllers
An FCE consists of the evaluation of functional capacities based on medical reporting observations andor a series of standardised tests performed by an occupational therapist This evaluation can give socially insured persons and medical advisors of the mutualities more insight into the participation possibilities of the socially insured person in function of the previous or next job To date the advisory doctor does not yet have the opportunity to have these evaluations carried out in Belgium The aim of this study is therefore to examine the impact of these FCEs with regard to people on incapacity for work who meet the following conditions
1 Belgian citizens on sick leave or work disability who meet the criteria determined by the article 1001 and 100 2 of the coordinated law of 14 July 1994 or by article 19 andor 20 of the RD 20 July 1971
2 The persons medical situation is stabilised no significant evolution due to illness procedure treatment
3 It is not a purely mentalpsychiatric disorder
4 From the point of view of the consulting physician there is a lack of consistent information on the capacity to return to work
5 Inclusion takes place from the 6th month of incapacity
6 The person is of working age 18-65 years
In this RCT 10 consulting physicians 30 occupational therapists and 200 persons on incapacity will be recruited Then persons on sick leavework disability are randomly divided into two groups 1 Persons in the control group receive the usual counselling by the medical advisor 2 Persons in the intervention group receive usual care and an FCE In the latter group the person on sick leave is matched by the researchers to an occupational therapist in his region and is invited to a FCE After the evaluation the person reviews the results with the occupational therapist and a report of the FCE is provided to the medical advisor Finally the person is contacted by the medical advisor if they wish to take certain actions as a result of the FCE report To measure the impact of the FCE the intervention and control groups thereby complete a questionnaire at four points in time at baseline after 3 months after 6 months and after 9 months This questionnaire is composed of validated instruments and in addition to background characteristics it questions work ability self-efficacy expectations of returning to work any steps taken to return to work pain intensity illness perception and beliefs regarding returning to work
As a second objective the impact on the medical advisors and other parties decision-making process will be investigated through qualitative interviews and focus groups To this end a process evaluation will be conducted This includes an examination of the implementation of the study the usability feasibility and quality of FCEs and their reporting and the underlying causal mechanisms of the intervention Using interviews and focus groups with medical advisors the impact of the FCE on the decision-making process will be investigated Using interviews with occupational therapists return-to-work coordinators and mediators of the regional services the usability feasibility and quality of the FCE will be investigated
An FCE consists of the evaluation of functional capacities based on medical reporting observations andor a series of standardised tests performed by an occupational therapist This evaluation can give socially insured persons and medical advisors of the mutualities more insight into the participation possibilities of the socially insured person in function of the previous or next job To date the advisory doctor does not yet have the opportunity to have these evaluations carried out in Belgium The aim of this study is therefore to examine the impact of these FCEs with regard to people on incapacity for work who meet the following conditions
1 Belgian citizens on sick leave or work disability who meet the criteria determined by the article 1001 and 100 2 of the coordinated law of 14 July 1994 or by article 19 andor 20 of the RD 20 July 1971
2 The persons medical situation is stabilised no significant evolution due to illness procedure treatment
3 It is not a purely mentalpsychiatric disorder
4 From the point of view of the consulting physician there is a lack of consistent information on the capacity to return to work
5 Inclusion takes place from the 6th month of incapacity
6 The person is of working age 18-65 years
In this RCT 10 consulting physicians 30 occupational therapists and 200 persons on incapacity will be recruited Then persons on sick leavework disability are randomly divided into two groups 1 Persons in the control group receive the usual counselling by the medical advisor 2 Persons in the intervention group receive usual care and an FCE In the latter group the person on sick leave is matched by the researchers to an occupational therapist in his region and is invited to a FCE After the evaluation the person reviews the results with the occupational therapist and a report of the FCE is provided to the medical advisor Finally the person is contacted by the medical advisor if they wish to take certain actions as a result of the FCE report To measure the impact of the FCE the intervention and control groups thereby complete a questionnaire at four points in time at baseline after 3 months after 6 months and after 9 months This questionnaire is composed of validated instruments and in addition to background characteristics it questions work ability self-efficacy expectations of returning to work any steps taken to return to work pain intensity illness perception and beliefs regarding returning to work
As a second objective the impact on the medical advisors and other parties decision-making process will be investigated through qualitative interviews and focus groups To this end a process evaluation will be conducted This includes an examination of the implementation of the study the usability feasibility and quality of FCEs and their reporting and the underlying causal mechanisms of the intervention Using interviews and focus groups with medical advisors the impact of the FCE on the decision-making process will be investigated Using interviews with occupational therapists return-to-work coordinators and mediators of the regional services the usability feasibility and quality of the FCE will be investigated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None