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临床试验/NCT02945397
NCT02945397已完成不适用

Effect Evaluation of the Work Rehabilitation Effort "Best iLag"

NORCE Norwegian Research Centre AS2 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2015年1月最近更新:
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
168
试验地点
2
主要终点
Number of days at work during follow-up period measured through data from the Norwegian Labour and Welfare Administration´s databases.

研究概览

简要总结

The study compares the effect of a group-based activity with an individual work-out activity on work participation.

详细描述

The study is an RCT comparing the effect of a group-based intervention with an individual work-out intervention on work participation. The target group is persons who are at risk of leaving the work force due to health issues, and people currently outside the work force. The interventions have a time-span of 3 months. Survey data will be collected at baseline, after three months (after intervention has ended), and after 15 months. Survey data include information on lifestyle, self-reported health, subjective health complaints and readiness for work. Register data on employment and welfare benefits will be collected from two years in advance of inclusion, and five years after inclusion. According to power calculations, the study will need 322 participants.

In addition to the effect evaluation, a process evaluation will also be performed. The process evaluation will examine content quality and adherence to guidelines, as well as feasibility of the group intervention. The process evaluation will consist of some survey data as well as interviews with service providers and participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Desire to work
  • Understand Norwegian sufficiently to complete surveys

排除标准

  • Not able to participate in the interventions due to personal or health-related constraints.

研究组 & 干预措施

Individual activity

Active Comparator

The individual activity consists of a 3 month membership card at a given gym. This is in addition to regular follow-up from welfare authorities.

干预措施: Individual activity (Behavioral)

Group-based activity

Active Comparator

The group-based activity consists of a 3 month group activity with weekly gatherings, focusing on coping, goal-setting and relevant information regarding available public services. This is in addition to regular follow-up from welfare authorities.

干预措施: Group-based activity (Behavioral)

结局指标

主要结局

Number of days at work during follow-up period measured through data from the Norwegian Labour and Welfare Administration´s databases.

时间窗: 7 years

次要结局

  • Subjective health complaints measured through questionnaire data.(15 months)
  • Self-rated health measured through questionnaire data.(15 months)
  • Sleep measured through questionnaire data.(15 months)
  • Alcohol use measured through questionnaire data.(15 months)
  • Regular exercise measured through questionnaire data.(15 months)
  • Bullying measured through questionnaire data.(15 months)
  • Work readiness measured through questionnaire data.(15 months)
  • Social support measured through questionnaire data.(15 months)
  • Fatigue measured through questionnaire data.(15 months)
  • Quality of life measured through questionnaire data.(15 months)
  • Coping measured through questionnaire data.(15 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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