Condition category
Musculoskeletal Diseases
Date applied
08/10/2006
Date assigned
15/01/2007
Last edited
28/10/2008
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 Theodora Vliet Vlieland

ORCID ID

Contact details

Leiden University Medical Center
Department of Rheumatology C1-R
P.O. Box 9600
Leiden
2300 RC
Netherlands
T.P.M.Vliet_Vlieland@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Multidisciplinary vocational rehabilitation for patients with chronic arthritis

Study hypothesis

This study was a randomised controlled trial comparing a job retention Vocational Rehabilitation program (VR group) with Usual outpatient Care (UC group), with 24 months of follow-up. After enrolment and baseline assessments had been completed, patients were randomly allocated to either the VR or the UC group. Randomisation was done with stratification for centre (academic versus non academic) and three diagnosis groups (Rheumatoid Arthritis [RA]; Ankylosing Spondylitis [AS], psoriatic arthritis, reactive arthritis; Systemic Lupus Erythematosus [SLE], or scleroderma), according to a randomisation list that was made up by a random digit generator. All clinical assessments were done by a trained research nurse who was blinded to the patients' treatment status. Assessments were done at baseline and after 6, 12, 18 and 24 months of follow-up. To maintain allocation concealment, patients were instructed not to inform the principal investigator or the research nurse about the type of care they received.

The aim of this trial is to investigate the effectiveness of a multidisciplinary job retention vocational rehabilitation program in patients with a rheumatic condition who were at risk for job loss.

Ethics approval

Ethics approval received from the Medical Ethics Committee Leiden University Medical Center in February 1999 (ref: P 69/98).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic arthritis (including rheumatoid, psoriatic and reactive)

Intervention

The job retention vocational rehabilitation program was delivered at the department of Rheumatology of the Leiden University Medical Center by a multidisciplinary team comprising a rheumatologist, a social worker, a physical therapist, an occupational therapist and a psychologist. Moreover, an occupational physician who was linked to the occupational health service of the Leiden University Medical Center was connected to the team. This occupational physician was not involved in the guidance of individual patients, but had a general advisory role. The organisation of the program was in the hands of a coordinator. All patients made at least two visits to the hospital in connection with the job retention vocational rehabilitation program.

The intervention consisted of a systematic assessment followed by education, vocational counselling, guidance, and medical or non-medical treatment. The basic assessment was done by a rheumatologist (current level of disease activity and joint destruction, presence of extra-articular manifestations or co-morbidity and extent and severity of activity limitations; prognosis regarding future impairments and activity limitations) and the coordinator (education level and previous jobs, systematic registration of the problems encountered in the current working situation, using a list of potential challenges and psychosocial situation). If necessary, additional team members were asked to see the patient in order to gather more information about specific aspects of the work situation.

Dependent on the specific problems of the individual patient, the intervention further consisted of education (such as providing written and oral information about the Dutch social security system regarding sick leave and work disability), counselling and guidance (such as the identification of resources for adapting the working environment or working hours, promotion of work self-efficacy), or treatment (such as adaptation of the medical treatment in consultation with the referring rheumatologist, exercise therapy, occupational therapy, functional training of relevant activities or mental restoration).

All information concerning the patient's health status, working situation and working challenges and the course of the process of education, counselling, guidance or treatment was listed in a final report. This report was then sent to the referring rheumatologist and the occupational physician connected with the patient's company if applicable. The total duration of the intervention varied, and lasted on average between four and 12 weeks.

Patients assigned to the UC group were treated and referred to other health professionals in relation to their working problem if regarded necessary by their rheumatologist. In addition, they all received the same written information about the Dutch social security system regarding sick leave and work disability as patients in the VR group.

The referring rheumatologists were informed about the treatment allocation. In both groups, physicians had free choice with respect to their medical prescriptions and other treatment strategies. All medical treatment and the use of health services during the intervention period and two-year follow-up were recorded in both groups.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The main outcome was the occurrence of job loss, defined as receiving an official full work disability pension or unemployment. The classification of job losses was based on the participants' records of their work status at every follow-up visit. Subjects being less then one year on full sick leave were classified as being in paid employment. In addition to job loss, the number of patients in whom the extent of the disability pension had increased (by receiving an official full disability pension or by receiving a new or a larger official partial disability pension) was recorded at every time point.

Secondary outcome measures

1. Satisfaction with the job, measured on a horizontal Visual Analogue Scale (VAS, range 0-10 cm). The anchor on the left was not at all satisfied and the anchor on the right was fully satisfied with the job. The VAS was only to be filled in by those subjects who had worked at least five days in the last month
2. Global assessments of pain and fatigue, measured on a VAS (0-10 cm). The anchors on the left were no pain and no fatigue whereas the anchors on the right were severe pain and severe fatigue
3. Physical functioning, using the Health Assessment Questionnaire (HAQ), a 20-item questionnaire comprising eight domains of activities of daily living
4. Anxiety and depression were measured by means of a Dutch version of the Hospital Anxiety and Depression Questionnaire (HADS). It contains two seven item scales: one for anxiety and one for depression both with a score range of zero to 21
5. Quality of life was measured using the RAND 36-item Health Survey. The RAND-36 was converted into two summary scales: the physical and mental component summary scales. The RAND includes the same items as the Medical Outcomes Study Short-Form (SF 36) and although the scoring procedures are somewhat different, the effects on final scores are minimal
6. From a social prospective, the cost-utility of a VR-program

Overall trial start date

01/03/1999

Overall trial end date

01/06/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 63 years
2. Has a chronic rheumatic disease (diagnosis Rheumatoid Arthritis [RA]; Ankylosing Spondylitis [AS], psoriatic arthritis, reactive arthritis; Systemic Lupus Erythematosus [SLE], or scleroderma)
3. All patients have a paid job (working full-time or part-time or being on sick leave, either with or without a partial work disability pension)
4. Having a self-perceived, disease related problem at work, threatening their ability to work

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

140

Participant exclusion criteria

1. Reaching the pensionable age within two years
2. Having another disease or situation influencing work ability

Recruitment start date

01/03/1999

Recruitment end date

01/06/2001

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Sponsor details

P.O. Box 93245
The Hague
2509 AE
Netherlands

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (grant ref: 940-36-009)

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16208658

Publication citations

  1. Results

    de Buck PD, le Cessie S, van den Hout WB, Peeters AJ, Ronday HK, Westedt ML, Breedveld FC, Vliet Vlieland TP, Randomized comparison of a multidisciplinary job-retention vocational rehabilitation program with usual outpatient care in patients with chronic arthritis at risk for job loss., Arthritis Rheum., 2005, 53, 5, 682-690, doi: 10.1002/art.21452.

Additional files

Editorial Notes