|- candidate number||14959|
|- NTR Number||NTR4024|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-jun-2013|
|- Secondary IDs||LCM-2013-IWC |
|- Public Title||Can early stage occupational therapeutic intervention reduce significantly the sick leave periods of selected incapacitated workers in daily practice of the medical officers in Belgium? A randomized controlled trial and cost-benefit analysis in members of Christelijke Mutualiteit (CM).|
|- Scientific Title||Can early stage occupational therapeutic intervention reduce significantly the sick leave periods of selected incapacitated workers in daily practice of the medical officers in Belgium? A randomized controlled trial and cost-benefit analysis in members of Christelijke Mutualiteit (CM).|
|- hypothesis||1. When current practice of medical officers in Belgium is expanded to include occupational therapeutic interventions at an early stage of the patients sick leave period, the amount of days of sick leave can be significantly reduced. |
2. A multidisciplinary approach, combined to the current medical assessment of patients into sick leave by musculoskeletal problems, psychological problems, and psychosomatic problems will shorten the sick leave period and prevent relapse if an inductive and supporting strategy is used to enhance return to work.
|- Healt Condition(s) or Problem(s) studied||Work disability, Muscoskeletal disorders, Psychological problems, sick leave days, Medical officer, Psychomatic problems, Occupational therapy|
|- Inclusion criteria||1. Age limits: lower limit is 16 years at the day of statement of their work inability and the upper limit is 60 years of statement of their work inability.|
Our study concerns that age cohort of the population with enough career perspective left.
2. Creating comparable groups the study population is limited to larger diagnostic groups : musculoskeletal problems, psychological problems, psychosomatic problems.
The choice for these categories is also based on the studies and experience that individuals s with these diagnoses are more likely to drop out for a long time and that work related issues play often a significant role. (cfr Statistics Disability Riziv).
3. The trial includes only CM members who have a fix contract with an employer . This RTW (Return to work) trial is focused on people with a normal stable work relation that is on strain.
4. The individual has to cooperate and sent back a completed questionnaire IWC. The willingness to cooperate is an inclusion criterion for the study.
5. The individual estimates the likelihood to resume his/her work within three months from the first sick leave day lower than 10 on a 0 to 10 scale. Individuals who are from the beginning almost certain to resume their work without problems within those three months are not included. The study focuses on those cases who are in some way problematic in regard to work resumption.
6. The study includes only individuals who sent back to us the signed informed consent to participate in the study within the first three months of the sick leave period. We want to study early intervention and therefore we define a cut off point at three months.
|- Exclusion criteria||1. Sick leave by (industrial) accident;|
2. Surgery (done or planned);
3. Psychiatric issue;
4. Insufficient understanding of Dutch language (all questionnaires are in Dutch);
6. Work inability has been refused from the beginning by the CM insurance physician;
8. Work already resumed or a communicated concrete plan to resume work.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2013|
|- planned closingdate||31-dec-2014|
|- Target number of participants||400|
|- Interventions||1. Intake|
In a comprehensive intake-interview ( approximately 1 hour) the occupational therapist will elaborate the possible thresholds towards reintegration. This intake-interview is based on the ICF, with as most important domains: work related data, person related date, context related data and health related data. This intake-interview contains questions that are selected out of the “ Vragenlijst Beleving en Beoordeling van Arbeid (VBBA)” , the Occupational Case Analysis and Rating Scale (OCAIRS) and the Vragenlijst ArbeidsRe-integratie (VAR).
Place of contact : the CM office. Not in the home or working place.
Time investment IWC:
An intake-interview with the occupational therapist will take approximately 1 hour. A report will be made for the health insurance physician ( adviserend geneesheer CM) . The participant will receive a copy of this report from the coach and will be asked whether he/she agrees with the contents of the report.
- Questionnaire specific for this investigation.
Outcome : plan of approach
Together with the participant the occupational therapist will edit a plan of approach to eliminate possible thresholds. In this way the occupational therapist can give the participant some tasks that he can execute at home. These homework commands can be registration tasks (e.g. free time activities,…), think commands (e.g. balance sheet,…) or do-commands
(e.g. make an appointment with the occupational physician,…). If the participant wants so, a
follow-up appointment can be planned.
2. Follow-up appointments
Through follow-up appointments the inworkcoach can attend and follow-up the process of resuming work. The commands that have been given can be discussed, information can be given about supporting measures, actions about adapted work restart.
Place of contact(s): the follow-up appointments will also take place in the regional office because of facilitating transposition and eliminating ambiguity.
Time investment IWC: for a follow-up appointment 30 minutes are foreseen. A report will be made and handed out at the participant. Aim is to achieve 5 follow-up appointments at most per participant.
|- Primary outcome||1. What is the effectiveness of occupational therapeutic interventions among work disabled persons with psychic and/of musculoskeletal troubles on return to work RTW (= number of sick-leave days)?|
2. What is the effectiveness of occupational therapeutic interventions among work disabled persons with psychic and/or musculoskeletal troubles on sustainable (lasting) work restart within 12 months?
|- Secondary outcome||1. What is the effectiveness of occupational therapeutic interventions among work disabled persons with psychic and/or musculoskeletal problems on their general wellbeing, resilience and self-efficacy after 6 and 12 months?|
2. Can we define differences in outcome between the subgroups : musculoskeletal problems/ psychic problems/ psychosomatic problems ?
3. Can we define predictive variables influencing primary outcome?
|- Timepoints||There are 3 time-points: |
T0: at the start of the incapacity
T1: 6 months after start of the incapacity
T2: 12 months after start of the incapacity
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Rik Loenders|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Dirk Dhollander|
|- Sponsor/Initiator ||Landsbond der Christelijke Mutualiteiten|
(Source(s) of Monetary or Material Support)
|Landsbond der Christelijke Mutualiteiten|
|- Brief summary||The inwerkcoach project is an innovative project in which an occupational therapy counseling / coaching is added to the existing consultations with the medical officer of the Christian Fund.|
When a declaration of incapacity occurs, the medical officer select this declaration problems. To members with mental, musculoskeletal or psychosomatic disorder is sent a questionnaire. With this questionnaire, we question the inclusion and exclusion criteria. When met all inclusion criteria, informed consent and first survey (T0) for the study sent. When informed consent completed and signed return to the researchers, the participant via a computer randomized into a control or intervention group.
All participants (control and intervention) are called by the medical officer in the same way.
Participants in the intervention group will be contacted to make an intake interview. Appointment by the inwerkcoach There can follow further follow conversations: purpose of this guidance / coaching is to inform, encourage to establish a work plan and discuss with employer and doctor people in an active way.
With this research we look into the people in the intervention group faster and more durable go to work compared to the control group.
|- Main changes (audit trail)|
|- RECORD||5-jun-2013 - 27-jun-2013|