Effectiveness of early intervention among employees at high risk for long-term sickness absence

ISRCTN	ISRCTN91445383
DOI	https://doi.org/10.1186/ISRCTN91445383
Protocol serial number	NTR214
Sponsor	University Maastricht (UM) (Netherlands)
Funder	ABN AMRO (Netherlands) - Arbo Services

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 15/05/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr N W H Jansen
Scientific

Department of Epidemiology
Maastricht University
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone	+31 (0)43 388 2384
Email	Nicole.Jansen@epid.unimaas.nl

Study information

Primary study design	Interventional
Study design	Randomised single blind active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	What is the effectiveness of early preventive intervention among employees at high risk for long-term sickness absence?
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Sickness absence
Intervention	The effectiveness of early intervention among employees at high risk for sickness absence will be determined by means of a randomised controlled trial, with an initial total follow-up period of 12 months. The study will be based on a sample of 10,000 employees of ABN AMRO in the Netherlands. Selection of this sample will be based on the initial letter of the employees surname. To ensure smooth enrolment in the trial, the study population will be divided in five batches. Employees at high risk for long-term sickness absence will be identified by the screening questionnaire Balansmeter. The study involves employees whose high risk for long-term sickness absence can be prompted by either somatic conditions or mental health complaints, or both. Employees will be asked to provide informed consent and those scoring above the cutoff point of the Balansmeter will be randomised over the experimental group and the control condition. Employees in the experimental group will receive early treatment. Early treatment involves an interview by the occupational physician, which may be followed either by further guidance by the occupational physician or by external referral/guidance. External referral may include psychotherapy, cognitive behavioural therapy or social work. The control group receives care as usual, as provided by the occupational physician, if the employee asks for help. In case of sickness absence the control group will receive socio-medical counselling in accordance with the practice guidelines of the NVAB. Outcomes will be evaluated at 6 and 12 months after randomisation.
Intervention type	Other
Primary outcome measure(s)	Sickness absence. All information regarding sickness absence will be gathered through record linkage on an individual level with the company register on sickness absence. Sickness absence measures include absence frequency, time to onset of first absence spell, and sickness absence duration. Sickness absence will be assessed during the complete follow-up period of 12 months.
Key secondary outcome measure(s)	Assessed at baseline and during follow-up by means of questionnaires: 1. (Mental) health status, capturing amongst others need for recovery from work, prolonged fatigue, and psychological distress 2. Working conditions, such as for example social support from supervisor and colleagues, psychological job demands, decision latitude and working hours 3. Medical consumption Follow-up measurements will take place at 6 and 12 months after randomisation.
Completion date	01/01/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	327
Key inclusion criteria	Employees at high risk for future long-term sickness absence as identified by a validated screening questionnaire called "Balansmeter".
Key exclusion criteria	1. Employees on sick leave 2. Pregnant employees 3. Treatment/guidance by occupational physician
Date of first enrolment	01/01/2003
Date of final enrolment	01/01/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of Epidemiology

Maastricht
6200 MD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan