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临床试验/NCT01568970
NCT01568970已完成不适用

Multidisciplinary Return-to-work Rehabilitation and Return-to-work Follow-up, a Randomized Study of Patients With Complex Symptom Disorders

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2012年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
214
试验地点
1
主要终点
Return to work

研究概览

简要总结

The large number of people on long-term sick leave is a major public health concern in Norway. The main causes of disability are musculoskeletal and mental disorders. Long-term sick leave causes a decline in individual life-quality, is associated with increased risk for mental disorders and represents a very large cost for the Norwegian society.

The purpose of this study is to determine whether the patients included return to work after rehabilitation at Hysnes Rehabilitation Centre. This includes an investigation of what is considered to be the effect of Return-to-work rehabilitation measured before, during and after the stay at the rehabilitation centre:

The study specifically looks at the effect of structured and standardized return-to-work follow up of the patient, including contact with stakeholders (general practitioner, social security office and workplace).

In addition there is a need to describe the patients participating in the program. The aetiology of complex symptom disorders is poorly understood and the role of genetics and stress is not translatable to a complex symptom population. This complicates the transition from current biological research to a clinical use regarding these patients. If the investigators can assist in understanding how these patients, who are multiusers of health care and have received sickness benefit for a long time, develop their disorders and symptoms, it will be of great importance to the Norwegian community. Therefore the study consists of multimodal measurements of the patients before, during and after a rehabilitation programme at Hysnes Rehabilitation Centre. These measures include genotype, saliva cortisol, medical-, psychological-, physiological diagnostics and work related factors.

Related aims:

Investigate if multidisciplinary treatment based on acceptance and commitment therapy, contributes to normalisation of cortisol release with regards to a standardized stress test.

See wether individual differences regarding the stress profile can predict return to work in patients with complex symptom disorders.

Investigate genetic risk factors in relation to Return to Work rehabilitation and identify treatment moderators in a multidisciplinary rehabilitation program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Return to work follow-up

Experimental

Regular contact between the patient and his/her caretaker at the rehabilitation center over a 6 month period, including joint communication between patient, caretaker at the rehabilitation center and stake holders such as social security office, general practitioner and workplace.

干预措施: Return-to-work Rehabilitation + Follow up (Behavioral)

Standard follow-up

Active Comparator

Standard follow-up of the patient after ended rehabilitation by the return-to-work stakeholders, ie. the general practitioner, social security office and the employer. Limited contact between the caretaker at the rehabilitation center and the patient and stakeholders.

干预措施: Return-to-work rehabilitation (Behavioral)

结局指标

主要结局

Return to work

时间窗: 1 year after the end of the stay at the rehabilitation center.

Differences in cumulative days of sick leave, as reported by the government database "FD-Trygd".

次要结局

  • quality of life(5 years after the end of the rehabilitation stay)
  • Functional status(5 year after the end of the rehabilitation stay)
  • level of symptoms (somatic and psychological)(5 year after the end of the rehabilitation stay,)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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