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临床试验/NCT03354091
NCT03354091已完成不适用

Active@Work - Optimizing Physical Activity at Work With Personalized Decision Support Among Individuals With Osteoarthritis.

Lund University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2017年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
Change in work ability

研究概览

简要总结

The aim of this project is to explore if monitoring physical activity including feedback can have any effect on physical activity level, function, work ability, health related quality of life or work productivity among individuals with hip and/or knee osteoarthritis. This will be performed by evaluating the use of mobile technology and activity monitoring to support physical activity in individuals with OA in a cluster randomized controlled trial. The investigators research questions are:

• Can an intervention, comprised of the above mentioned technology, have any effect on physical activity level, function, work ability, quality of life or work productivity among individuals with OA?

详细描述

Methods Design and setting The project will be performed as a cluster randomized controlled intervention study within primary health care in the region of Skåne and Halland.

Sample Patients who are referred to the patient education program for OA in primary health care will be invited to participate in the project. Participants will also be recruited using advertisement on social media. Participants recruited from social media will attend the patient education program for OA arranged by this project.

There will be one control group and one intervention group, see details below:

A. Patient education program and physical activity monitoring. C. Patient education program (control).

Each group within the patient education program for OA will be randomized to either group A or group C. Patients that fulfil the inclusion criteria will then be asked to participate. Digital (BankID or e-legitimation) informed consent will be obtained at the project's website. Recruitment of participants in intervention group A and control group C starts in autumn 2017 and continues through spring 2019 or when sufficient numbers of participants have been included.

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
Single (Investigator)

盲法说明

Masking is performed through sealed envelopes. The investigator has no knowledge of which patients who is randomized to intervention or control

入排标准

年龄范围
18 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Working at least 50 %

排除标准

  • Not being able to do physical activity, non-Swedish speaking

结局指标

主要结局

Change in work ability

时间窗: Baseline, 3 months, 6 months, 12 months

Questionnaire Work ability index (WAI) 7-49 points. 7-27 points (bad) - restore work ability. 28-36 points (moderate) - improve work ability. 37-43 points (good) - support work ability. 44-49 points (very good) - support work ability.

次要结局

  • Change in work productivity(Baseline, 3 months, 6 months, 12 months)
  • Change in physical activity(Baseline, 3 months, 6 months, 12 months)
  • Change in quality of life(Baseline, 3 months, 6 months, 12 months)
  • Change in function of Hip or knee(Baseline, 3 months, 6 months, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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