Fit for Work' evaluation study: the effects of a multidisciplinary re-employment programme for persons with mental health
|- candidate number||14590|
|- NTR Number||NTR3920|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-mrt-2013|
|- Secondary IDs||200210005 ZonMW|
|- Public Title||Fit for Work' evaluation study: the effects of a multidisciplinary re-employment programme for persons with mental health
|- Scientific Title||Fit for Work' evaluation study: the effects of a multidisciplinary re-employment programme for persons with mental health
|- hypothesis||The Fit4Work programme will improve mental health and increase labour force and social participation compared to usual re-employment activities and health care in longterm unemployed persons with mental health problems.|
|- Healt Condition(s) or Problem(s) studied||Mental health, Social participation, Return to work, Self-perceived health|
|- Inclusion criteria||1. Longterm unemployed persons, aged <= 50 years, with mental health problems;|
2. Sufficient labour market skills that will enable work resumption during 18-24 months of reintegration activities;
3. Sufficient skills to be able to provide answers in an interview;
4. Existing contact or eligible for contact with primary mental health care services.
|- Exclusion criteria||1. Severe acute psyciatric illness;|
2. Drug addiction or being homeless.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2012|
|- planned closingdate||31-dec-2015|
|- Target number of participants||1000|
|- Interventions||The F4W intervention consists of an intersectoral integrated approach aimed at improving mental health and addressing
barriers in social participation and labour force participation. The intersectoral approach is assured by a multidisciplinary team consisting of a psychologist, a nurse ("wijkverpleegkundige"), a social worker, a labour market expert, and a social services
officer. In a structured intake mental health problems, as well co-existing social or physical problems are identified. The
structured intake will guide the decision how to tailor mental health interventions and re-integration programmes to the specific needs of the unemployed person. The tailored interventions will consist of mental health interventions (offered by mental health care organisations) and labour market interventions, but may be extended with health behavioural interventions (offered through municipal health organisations), and social interventions. The purpose of the new intersectoral intervention is to bring
about an acceleration in the re-integration process.
The control group will consist of subjects that are referred to re-integration programmes in the same month as the referral to the intervention. Subjects in the control group will receive the regular reintegration programmes offered by the G4. Thus, the subjects in the reference group will follow the current routes. Several social and medical co-interventions are expected in the control group and these will not be withdrawn from these subjects.
Persons in the
intervention group will receive a structured F4W intervention for up to 2 years, whereas the persons in the control group will receive the usual reintegration activities and health care when sought during the complete study duration.
|- Primary outcome||1. Mental health;|
2. Work resumption in paid employment;
3. Work resumption in supported employment (sheltered jobs);
4. Formal and informal social participation.
|- Secondary outcome||1. Self-esteem;|
3. Social problems;
4. Physical health;
5. Medical consumption.
|- Timepoints||1. Baseline;|
2. 12 months;
3. 24 months.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| R.M. Rijn, van|
|- CONTACT for SCIENTIFIC QUERIES|| A. Burdorf |
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Public Health|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Unemployment is an important factor underlying health inequalities. Unemployed persons have a higher mortality and more
often experience diseases with functional limitations. Unemployment may cause deterioration of health, especially mental
health, and a poor health increases the risk of becoming unemployed. A poor mental health acts as a barrier for return to paid employment. Vice versa, there are clear indications that re-employment may have a profound influence on health. Inclusion of unemployed people in the workforce is an important strategy to reduce socioeconomic inequalities in health.
The recent collaboration of Municipal Health Services, Social Security Services, and UWV-Werkbedrijf in the four largest cities
of the Netherlands will introduce the Fit-4-Work programme for unemployed persons with mental health problems. This programme consists of a structured diagnosis and treatment of psychiatric problems, integrated in reintegration with individual placement to work. This study will evaluate the effectiveness of Fit-4-Work with regard to mental health, return-to-work, social participation, and costs and benefits from societal perspective as well the particular position of different services. The study is a pragmatic randomised controlled trial (RCT) with two arms: intervention (500 persons) and control group (500 persons). Persons in the
intervention group will receive a structured F4W intervention for up to 2 years, whereas the persons in the control group will receive the usual reintegration activities and health care when sought during the complete study duration. The target population
consists of long-term unemployed subjects (social security payments through WIJ, WWB, WIA, or WAJONG), often in a low
socio-economic position and belonging to ethnic groups, such as Surinamese & Antilleans, Moroccans, and Turks.
The F4W intervention consists of an intersectoral integrated approach aimed at improving mental health and addressing
barriers in social participation and labour force participation.The purpose of the new intersectoral intervention is to bring about an acceleration in the re-integration process. In order to achieve an acceptable response in this study population, it only will be feasible to collect the necessary information by means of a structured interview. Given the size of the study population and the interview efforts, data collection by interview will be limited to
baseline, 12 months, and 24 months follow-up. The primary outcome measures are mental health, work resumption in paid employment or supported employment (sheltered jobs), and social participation. Secondary outcome measures are self-esteem, resilience, social problems, physical health, and medical consumption. The evaluation of the intervention will consist of a formative evaluation (are the goals of the intervention achieved), an effect evaluation (what is the effectiveness and the cost-effectiveness), and a summative evaluation (which elements in the intervention most likely contribute to its effectiveness). We assume enrolment of 500 subjects in intervention and in reference group. With an initial participation of 70% and loss-to-follow-up of 30%, 245 subjects will complete the study in each group. Thus, we are able to detect a difference of at least 12% in the primary outcome measure (40% work resumption versus 29% in control group). For continuous outcome measures,
such as mental health, an effect size of 0.25 can be demonstrated.|
|- Main changes (audit trail)|
|- RECORD||25-mrt-2013 - 6-apr-2013|
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