Effects of a Self-management Course for Adults on Sick-leave (jos)
7 dicembre 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
600
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Copenhagen, Danimarca, 2100
- The Danish Comitee for Health Education
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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
Altri nomi:
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Nessun intervento: Treatment as usual
Participants in the control-group receive standard rehabilitation care and follow-up in the job-center.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Return to work, duration
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Common mental disorders
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Health-care utilization
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Martin H Olesen, PhD, Aarhus University and Aarhus University Hospital
- Cattedra di studio: Jan Høgelund, PhD, VIVE - The Danish Center for Social Science Research
- Investigatore principale: Mimi Y Mehlsen, PhD, University of Aarhus
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2014
Completamento primario (Effettivo)
1 giugno 2016
Completamento dello studio (Effettivo)
1 agosto 2016
Date di iscrizione allo studio
Primo inviato
8 maggio 2014
Primo inviato che soddisfa i criteri di controllo qualità
9 maggio 2014
Primo Inserito (Stima)
12 maggio 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 dicembre 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 dicembre 2017
Ultimo verificato
1 settembre 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- auh_JOS_sfi-01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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