|- candidate number||10513|
|- NTR Number||NTR3151|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-nov-2011|
|- Secondary IDs||11-4-115 METC|
|- Public Title||An intervention to improve cooperation between absent employees and their employers.|
|- Scientific Title||Improved cooperation between absent employees and their employers.|
|- Healt Condition(s) or Problem(s) studied||Workers, Employers|
|- Inclusion criteria||The inclusion criteria for the employees are that they:|
1. Are on sick leave for at least two weeks;
2. Expect to be absent from work for at least four working weeks;
3. Are appointed to work for at least twelve hours per week;
4. Are aged between 18 and 60 years old.
Employees can participate in the study only when their employers are willing to participate as well.
|- Exclusion criteria||The exclusion criteria for the employees are that they:|
1. Expect to resume work within four weeks after they called in sick;
2. Have a labour contract that ends within eighteen months;
3. Suffer from a terminal illness;
4. Are absent for more than eighth weeks. According to Dutch law, a return to work plan is composed before eighth weeks of absence. If such as plan exists, the intervention may interfere with the plan;
5. Take part in another study or receive other kinds of support (such as coaching) to return to work.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-mrt-2011|
|- planned closingdate||31-aug-2014|
|- Target number of participants||140|
|- Interventions||Intervention group:|
1. Absent employees and their employers use a guideline to structure and intensify their cooperation. Among others, this guideline advises employees and employers about their meeting frequency, how to prepare for- and what to discuss during the meetings. As part of this guideline, employees and employers discuss when and how the employees can return to work;
2. Every four to six weeks, employees and employers fill out a questionnaire about their cooperation;
3. In case the results of the questionnaire point out a lack of cooperation, employees and employers are supported by a third actor (an occupational physician or other professional) to cooperate with each other.
Care as usual/regular support to return to work, provided by employers and occupational physicians.
|- Primary outcome||Proximal outcomes:|
1. Outcome name: Mutual trust measured by means of among others a self-developed questionnaire. Time points: Every four to six weeks until the employee returns to work;
2. Outcome name: Mutual dependency with a self-developed questionnaire. Time points: Every four to six weeks until the employee returns to work;
3. Outcome name: Cooperation with among others self-developed questionnaires. Time points: Every four to six weeks until the employee returns to work.
1. Outcome name: Participation (sickness absence) with the Prodisq. Time points: 0, 6 and 12 months;
2. Outcome name: Health with parts of the SF-36. Time points: 0, 6 and 12 months;
3. Outcome name: Quality of life with the EQ-5D-5L. Time points: 0, 6 and 12 months;
4. Outcome name: Care consumption with the TIQP. Time points: 0, 6 and 12 months.
|- Secondary outcome||Outcome name: Satisfaction about support provided by the third actor (measured by means of a self-developed questionnaire in intervention group only). Time points: As soon as possible after the employee returned to work. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. Nicole Hoefsmit|
|- CONTACT for SCIENTIFIC QUERIES||MSc. Nicole Hoefsmit|
|- Sponsor/Initiator ||Stichting Instituut GAK (SIG), University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|Stichting Instituut GAK (SIG)|
|- Brief summary||A quasi experimental study to test the effects of a minimal intervention on among others participation (sickness absence) of employees.|
The intervention group receives: A) a guideline to structure and intensify cooperation between absent employees and their employers; B) regular testing moments (employees and employers fill out a questionnaire about their cooperation); C) in case of insufficient cooperation, a third actor (for example an occupational physician) supports employees and their employers to cooperate with each other. The control group receives care as usual.
|- Main changes (audit trail)|
|- RECORD||8-nov-2011 - 28-nov-2011|