Effects of a Self-management Course for Adults on Sick-leave (jos)
7. desember 2017 oppdatert av: University of Aarhus
Effects of a Self-management Course for Adults on Sick-leave; Outcomes in Registry Based Measures of Return to Work and Questionnaire Based Measures of Well-being and Quality of Life
The purpose of the current study is to determine the efficacy of a self-management course for workers on sick-leave as an add-on to standard rehabilitation care and follow-up (treatment as usual). Outcomes are registry based measures of return to work, and questionnaire based measures of well-being and quality of life.
We thus, hypothesize that the program will improve workers return to work rates and self-reported/psychological well-being.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
The intervention course is a Danish adaptation of The Chronic Disease Self-Management Program (CDSMP), tailored towards workers on sick-leave. The original program has been developed by The Stanford Patient Education Research Center. The translation and adaptation has been conducted by The Danish Committee for Health Education.
Previous studies have examined the program with respect to specific chronic diseases (e.g., Arthritis), quality of life, well-being and health-care utilization, though non-otherwise specified workers on sick-leave and return work have not been examined before.
The framework of CDSMP is social-cognitive learning theory in which self-efficacy plays a central role.
Studietype
Intervensjonell
Registrering (Faktiske)
600
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Copenhagen, Danmark, 2100
- The Danish Comitee for Health Education
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Insured persons who receive sick-leave compensation from the Danish State
- Persons who are listed as sick from a job
- Persons who have been categorized as "2 - risk" or "3 - chronic" case by the job-center
- The health problem reflects a chronic or a long-term condition
- The person acknowledges a chronic or long-term condition
- The person wants to work with his or her condition
- The person wants to return to work
- The person volunteers to participate
Exclusion Criteria:
- Persons who are listed sick for more than 16 weeks
- Persons who are categorized as "1 - easy" by the job-center
- The person does not understand or speak danish
- History or signs of aggressive behavior and violence
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Self-management program (SMP)
Participants in the experimental group receive six weekly group-sessions of self-management and patient education; specifically targeting self-management of the return to work process and disease symptoms.
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A self-management course
Andre navn:
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Ingen inngripen: Treatment as usual
Participants in the control-group receive standard rehabilitation care and follow-up in the job-center.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Return to work, duration
Tidsramme: Weekly from baseline till 1 year follow-up
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DREAM-registry (supported by the Danish Ministry of Employment) combined with income/employment information from e-income (supported by the Danish Tax Authorities).
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Weekly from baseline till 1 year follow-up
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Well-being and Quality of life
Tidsramme: up to 5 month follow-up
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WHO-5 Well-being and WHO Quality of Life/Satisfaction items (Bech, 2012)
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up to 5 month follow-up
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Common mental disorders
Tidsramme: Baseline, post-intervention and 4,5 month follow-up
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The CMDQ questionnaire i based on SCL-90 (Symptom Checklist) and measures somatization, health-anxiety, depression, anxiety and alcohol consumption (Christensen et al., 2005)
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Baseline, post-intervention and 4,5 month follow-up
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Disease self-efficacy scale
Tidsramme: Baseline, post-intervention and 4,5 month follow-up
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The University of Washington Self-efficacy scale, 6 item version (Amtmann et al., 2012)
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Baseline, post-intervention and 4,5 month follow-up
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Self-regulation (return to work)
Tidsramme: Baseline, post-intervention and 4,5 month follow-up
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Return to work self-regulation questionnaire, measuring internalization of reasons for trying to return to work; adapted from the Treatment Self-regulation Questionnaire (Levesque et al., 2007)
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Baseline, post-intervention and 4,5 month follow-up
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Self-management scale
Tidsramme: Baseline, post-intervention and 4,5 month follow-up
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A measure of six cognitive strategies which are taught at the course (Lorig et al., 1996)
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Baseline, post-intervention and 4,5 month follow-up
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Illness Perception questionnaire
Tidsramme: Baseline, post-intervention and 4,5 month follow-up
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A measure of 8 items measuring the threat of illness or disease (B-IPQ; Broadbent, Petrie, Main & Weinman, 2006)
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Baseline, post-intervention and 4,5 month follow-up
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Health-care utilization
Tidsramme: Baseline, post-intervention and 4,5 month follow-up
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Items that measure utilization of health-care consultation (Lorig et al., 1996)
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Baseline, post-intervention and 4,5 month follow-up
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Medicine consumption
Tidsramme: Baseline, post-intervention and 4,5 month follow-up
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Generic items that measure consumption of medicines such as anti-depressants and anxiety medicine, use of pain killers and sleep pills
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Baseline, post-intervention and 4,5 month follow-up
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Adherence to treatment
Tidsramme: Baseline, post-intervention and 4,5 month follow-up
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Adherence to disease specific treatment (inspired by the MMAS-4; Morisky & DiMatteo, 2011)
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Baseline, post-intervention and 4,5 month follow-up
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Common symptoms
Tidsramme: Baseline, post-intervention and 4.5 month follow-up
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Pain, breath, being tired, sleep quality; measured by VAS scales (Lorig et al., 1996)
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Baseline, post-intervention and 4.5 month follow-up
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Decisional Balance (return to work)
Tidsramme: Baseline, post-intervention and 4,5 month follow-up
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Generic items that measures how the advantages and disadvantages of returning to work are balanced (Franche & Krause, 2002)
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Baseline, post-intervention and 4,5 month follow-up
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Return to work expectations
Tidsramme: Baseline, post-intervention and 4,5 month follow-up
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Generic items that measure expectations about returning to work (Niewenhuiksen, Noordik, van Dijk & van der Klink.
2013; Schultz et al., 20014)
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Baseline, post-intervention and 4,5 month follow-up
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Martin H Olesen, PhD, Aarhus University and Aarhus University Hospital
- Studiestol: Jan Høgelund, PhD, VIVE - The Danish Center for Social Science Research
- Hovedetterforsker: Mimi Y Mehlsen, PhD, University of Aarhus
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
- Amtmann D, Bamer AM, Cook KF, Askew RL, Noonan VK, Brockway JA. University of Washington self-efficacy scale: a new self-efficacy scale for people with disabilities. Arch Phys Med Rehabil. 2012 Oct;93(10):1757-65. doi: 10.1016/j.apmr.2012.05.001. Epub 2012 May 7.
- Morisky DE, DiMatteo MR. Improving the measurement of self-reported medication nonadherence: response to authors. J Clin Epidemiol. 2011 Mar;64(3):255-7; discussion 258-63. doi: 10.1016/j.jclinepi.2010.09.002. Epub 2010 Dec 8. No abstract available.
- Marks R, Allegrante JP, Lorig K. A review and synthesis of research evidence for self-efficacy-enhancing interventions for reducing chronic disability: implications for health education practice (part I). Health Promot Pract. 2005 Jan;6(1):37-43. doi: 10.1177/1524839904266790.
- Marks R, Allegrante JP, Lorig K. A review and synthesis of research evidence for self-efficacy-enhancing interventions for reducing chronic disability: implications for health education practice (part II). Health Promot Pract. 2005 Apr;6(2):148-56. doi: 10.1177/1524839904266792.
- Bech, P. Clinical Psychometrics. Oxford: Wiley-Blackwell, 2012.
- Christensen KS, Fink P, Toft T, Frostholm L, Ornbol E, Olesen F. A brief case-finding questionnaire for common mental disorders: the CMDQ. Fam Pract. 2005 Aug;22(4):448-57. doi: 10.1093/fampra/cmi025. Epub 2005 Apr 6.
- Bjorner JB, Damsgaard MT, Watt T, Groenvold M. Tests of data quality, scaling assumptions, and reliability of the Danish SF-36. J Clin Epidemiol. 1998 Nov;51(11):1001-11. doi: 10.1016/s0895-4356(98)00092-4.
- Franche RL, Krause N. Readiness for return to work following injury or illness: conceptualizing the interpersonal impact of health care, workplace, and insurance factors. J Occup Rehabil. 2002 Dec;12(4):233-56. doi: 10.1023/a:1020270407044.
- Nieuwenhuijsen K, Noordik E, van Dijk FJ, van der Klink JJ. Return to work perceptions and actual return to work in workers with common mental disorders. J Occup Rehabil. 2013 Jun;23(2):290-9. doi: 10.1007/s10926-012-9389-6.
- Schultz IZ, Crook J, Meloche GR, Berkowitz J, Milner R, Zuberbier OA, Meloche W. Psychosocial factors predictive of occupational low back disability: towards development of a return-to-work model. Pain. 2004 Jan;107(1-2):77-85. doi: 10.1016/j.pain.2003.09.019.
- Levesque CS, Williams GC, Elliot D, Pickering MA, Bodenhamer B, Finley PJ. Validating the theoretical structure of the Treatment Self-Regulation Questionnaire (TSRQ) across three different health behaviors. Health Educ Res. 2007 Oct;22(5):691-702. doi: 10.1093/her/cyl148. Epub 2006 Nov 30.
- Lorig, K., Stwart, A., Ritter, P., Gonzales, V., Laurent, D., & Lynch, J. Outcome measures for health education and other health care interventions. Thousand Oaks, CA: Sage Publications. 1996.
- Lorig K, Laurent DD, Plant K, Krishnan E, Ritter PL. The components of action planning and their associations with behavior and health outcomes. Chronic Illn. 2014 Mar;10(1):50-9. doi: 10.1177/1742395313495572. Epub 2013 Jul 9.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2014
Primær fullføring (Faktiske)
1. juni 2016
Studiet fullført (Faktiske)
1. august 2016
Datoer for studieregistrering
Først innsendt
8. mai 2014
Først innsendt som oppfylte QC-kriteriene
9. mai 2014
Først lagt ut (Anslag)
12. mai 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. desember 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. desember 2017
Sist bekreftet
1. september 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- auh_JOS_sfi-01
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .