Condition category
Signs and Symptoms
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
15/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr N W H Jansen

ORCID ID

Contact details

Department of Epidemiology
Maastricht University
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 388 2384
Nicole.Jansen@epid.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR214

Study information

Scientific title

Acronym

Study hypothesis

What is the effectiveness of early preventive intervention among employees at high risk for long-term sickness absence?

Ethics approval

Received from the local medical ethics committee

Study design

Randomised single blind active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

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 employeesÂ’ 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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/01/2003

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Employees at high risk for future long-term sickness absence as identified by a validated screening questionnaire called "Balansmeter".

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

327

Participant exclusion criteria

1. Employees on sick leave
2. Pregnant employees
3. Treatment/guidance by occupational physician

Recruitment start date

01/01/2003

Recruitment end date

01/01/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Epidemiology
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

University Maastricht (UM) (Netherlands)

Sponsor details

Department of Epidemiology
P.O. Box 616
Maastricht
6200 MD
Netherlands
Nicole.Jansen@epid.unimaas.nl

Sponsor type

University/education

Website

http://www.unimaas.nl/default.asp?taal=en

Funders

Funder type

Industry

Funder name

ABN AMRO (Netherlands) - Arbo Services

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes