Effects of a Self-management Course for Adults on Sick-leave (jos)
7 décembre 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
600
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Copenhagen, Danemark, 2100
- The Danish Comitee for Health Education
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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
Autres noms:
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Aucune intervention: Treatment as usual
Participants in the control-group receive standard rehabilitation care and follow-up in the job-center.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Return to work, duration
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Common mental disorders
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Health-care utilization
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Martin H Olesen, PhD, Aarhus University and Aarhus University Hospital
- Chaise d'étude: Jan Høgelund, PhD, VIVE - The Danish Center for Social Science Research
- Chercheur principal: Mimi Y Mehlsen, PhD, University of Aarhus
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2014
Achèvement primaire (Réel)
1 juin 2016
Achèvement de l'étude (Réel)
1 août 2016
Dates d'inscription aux études
Première soumission
8 mai 2014
Première soumission répondant aux critères de contrôle qualité
9 mai 2014
Première publication (Estimation)
12 mai 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 décembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 décembre 2017
Dernière vérification
1 septembre 2016
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- auh_JOS_sfi-01
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