Effects of a Self-management Course for Adults on Sick-leave (jos)
2017年12月7日 更新者：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.
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
600
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Copenhagen、丹麦、2100
- The Danish Comitee for Health Education
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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
其他名称：
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无干预：Treatment as usual
Participants in the control-group receive standard rehabilitation care and follow-up in the job-center.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Return to work, duration
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Common mental disorders
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Health-care utilization
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Martin H Olesen, PhD、Aarhus University and Aarhus University Hospital
- 学习椅：Jan Høgelund, PhD、VIVE - The Danish Center for Social Science Research
- 首席研究员：Mimi Y Mehlsen, PhD、University of Aarhus
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年9月1日
初级完成 (实际的)
2016年6月1日
研究完成 (实际的)
2016年8月1日
研究注册日期
首次提交
2014年5月8日
首先提交符合 QC 标准的
2014年5月9日
首次发布 (估计)
2014年5月12日
研究记录更新
最后更新发布 (实际的)
2017年12月8日
上次提交的符合 QC 标准的更新
2017年12月7日
最后验证
2016年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.