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临床试验/NCT02136056
NCT02136056已完成不适用

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

University of Aarhus1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
1
主要终点
Well-being and Quality of life

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Self-management program (SMP)

Experimental

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.

干预措施: Self-management program (SMP) (Behavioral)

Treatment as usual

No Intervention

Participants in the control-group receive standard rehabilitation care and follow-up in the job-center.

结局指标

主要结局

Well-being and Quality of life

时间窗: up to 5 month follow-up

WHO-5 Well-being and WHO Quality of Life/Satisfaction items (Bech, 2012)

Return to work, duration

时间窗: Weekly from baseline till 1 year follow-up

DREAM-registry (supported by the Danish Ministry of Employment) combined with income/employment information from e-income (supported by the Danish Tax Authorities).

次要结局

  • Self-regulation (return to work)(Baseline, post-intervention and 4,5 month follow-up)
  • Self-management scale(Baseline, post-intervention and 4,5 month follow-up)
  • Common mental disorders(Baseline, post-intervention and 4,5 month follow-up)
  • Disease self-efficacy scale(Baseline, post-intervention and 4,5 month follow-up)
  • Illness Perception questionnaire(Baseline, post-intervention and 4,5 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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