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Multidisciplinary Return-to-work Rehabilitation and Return-to Work Follow-up

4 december 2018 uppdaterad av: Norwegian University of Science and Technology

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

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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Faktisk)

214

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Trondheim, Norge
        • Hysnes Helsefort, St Olavs Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 59 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion criteria:

  • Age between 18-59 years
  • A self defined goal of increasing their work ability and work participation within a period of no more than six months
  • They fill the criteria of a complex symptom disorder, or they are diagnosed with a common mental disorder
  • A satisfactory level of examination and treatment to participate at Hysnes Rehabilitation Centre
  • Sick leave > 8weeks or receiving work ability assessment benefit for any diagnosis, except as stated below.
  • On a level of linguistic, physical and mental function required to participate in the rehabilitation

Exclusion criteria:

  • Ongoing alcohol/drug abuse
  • Ongoing psychosis, ongoing manic episode or suicide risk
  • Pregnancy

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Return to work follow-up
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.
3 1/2 weeks of Return-to-work rehabilitation followed by 6 months of Return-to-work follow-up
Andra namn:
  • Acceptance commitment therapy
Aktiv komparator: Standard follow-up
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.
3 1/2 weeks of Return-to-work rehabilitation followed by standard follow-up
Andra namn:
  • Acceptance commitment therapy

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Return to work
Tidsram: 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".
1 year after the end of the stay at the rehabilitation center.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
quality of life
Tidsram: 5 years after the end of the rehabilitation stay
Quality of life is assessed by 15D, SF8 and function subscale in SF-36
5 years after the end of the rehabilitation stay
Functional status
Tidsram: 5 year after the end of the rehabilitation stay
Functional status will be measured with elements from the Norwegian Function Assessment Scale (Osteras et al., 2007) and the function subscale of SF-36 (Ware Jr & Sherbourne, 1992)
5 year after the end of the rehabilitation stay
level of symptoms (somatic and psychological)
Tidsram: 5 year after the end of the rehabilitation stay,

The Hospital Anxiety and Depression Scale (HADS) measure changes in anxiety and depression.

Changes regarding physical and mental fatigue are registered through the Chalder Fatigue Questionnaire.

Changes in participants subjective experience of pain measured by numerical rating scale (NRS)

5 year after the end of the rehabilitation stay,

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Petter Borchgrevink, Norwegian University of Science and Technology

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2012

Primärt slutförande (Faktisk)

1 juni 2014

Avslutad studie (Faktisk)

1 september 2018

Studieregistreringsdatum

Först inskickad

8 mars 2012

Först inskickad som uppfyllde QC-kriterierna

29 mars 2012

Första postat (Uppskatta)

2 april 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 december 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 december 2018

Senast verifierad

1 december 2018

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 2010/2404

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