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Requirements and Functional Schedule as a Part of Painrehabilitation.

2021年10月29日 更新者:Katarina Danielsson、Uppsala University

Requirements and Functional Schedule- An Intervention to Use in Painrehabilitation, to Strengthen the Collaboration Between the Healthcare, Employers and Employees

Requirements and functional Schedule also calen Demand Ability Protocol (DAP) is an intervention that has been tested and found useful in occupational health service. The intervention aims to strengthen the collaboration between Health care, employers and employee. The intervention is based on a structured interview about the employers demands at work. This intervention (DAP) will in the present study be evaluated in pain rehabilitation both qualitatively and quantitatively.

研究概览

详细说明

Description of the intervention: Demand and Ability Protocol Demand and Ability Protocol (DAP) is an intervention linked to the International Classification of Functioning, Disability and Health, and is based on the Dutch Functional Ability List and knowledge about disability in working life (Brouwer et al, 2002). The intervention has been further developed and modified in Norway and is primarily used in occupational health care services for collaboration between an employee and his or her immediate manager (Engbers & Furuland, 2006).

The intervention consists of a structured conversation between the patient and his immediate manager under the guidance of licensed medical staff (in this case REKO) with knowledge of the requirements of the patient's work and his/her current functional ability. The intervention takes about 90 minutes excluding preparation time for REKO.

DAP consider the following domains; 1) mental and cognitive ability, 2) basic skills and social ability, 3) tolerance for physical conditions, 4) ability to work dynamically, 5) ability to work statically and 6) to be able to work certain times.

Based on the above domains, a structured review is made of the balance between requirements and function in current work in order to identify possible adaptations and measures at the workplace. During the intervention, the work requirements and the patient's function/ability are identified on a three-point scale and in domains where the rating of requirements and function/ability does not match, there is thus an imbalance, and here adjustments or changed tasks may be relevant to consider increasing work ability and reducing sick leave. The intervention concludes with a summary of the situation and joint development of appropriate measures/adaptations to promote the patient's RTW. This is documented on a form, which is signed by both the patient and the manage

研究类型

介入性

注册 (预期的)

150

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。

学习联系方式

研究联系人备份

学习地点

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

有资格学习的性别

全部

描述

Inclusion Criteria:

Chronic pain, has an employment

Exclusion Criteria:

no longer than 6 month of total sick-leave

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:治疗
  • 分配:非随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Painrehabilitation + Demand and ability protocol
Will receive pain-rehabilitation and the intervention ( an interview called Requirements and functional Schedule, with the patients employer and an occupational therapist)
An interview with the employee and the employer where the occupational worker is leading the interview and a pain rehabilitation-program
有源比较器:Painrehabilitation
Will receive pain-rehabilitation
a pain rehabilitation-program

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
Absence from work (sickleave) measured with a question to the participants
大体时间:Changes from baseline in absence from work to the end of the rehab program (average 4month)
Less absence from work
Changes from baseline in absence from work to the end of the rehab program (average 4month)
Absence from work (sickleave) measured with a question to the participants
大体时间:Changes from baseline in absence from work through study completion (average 1,5 years)
Less absence from work
Changes from baseline in absence from work through study completion (average 1,5 years)

次要结果测量

结果测量
措施说明
大体时间
Changes in EuroQol 5-dimensions questionnaire (EQ-5D)
大体时间:Change from baseline in EuroQol 5-dimensions through study completion (average 1,5 years)

Changes in quality of Life measured with the EuroQol 5-dimensions. Each combination of values has an idex value where 1 is the best quality of life. The questionnaire also includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher qulaity of life

.

Change from baseline in EuroQol 5-dimensions through study completion (average 1,5 years)
Changes in EuroQol 5-dimensions
大体时间:Change from baseline in EuroQol 5-dimensions to the end of the rehab program (average foru month)
Changes in quality of Life measured with the EuroQol 5-dimensions. Each combination of values has an idex value where 1 is the best quality of life. The questionnaire also includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher qulaity of life
Change from baseline in EuroQol 5-dimensions to the end of the rehab program (average foru month)
Changes in Anxiety and depression
大体时间:Change from baseline in anxiety and depression through study completion (average 1,5 years)hs)
Changes in Hospital Anxiety and Depression Scale (HADS). The scale icludes two subscales one focusing on anxiety symptoms and one on depressive symptoms. The minimum value is 0 and the maximum value is 21 for each subscale. Higher scores means worse outcome.
Change from baseline in anxiety and depression through study completion (average 1,5 years)hs)
Changes in Anxiety and depression
大体时间:Change from baseline in anxiety and depression to the end of the rehab program (average four month)
Changes in Hospital Anxiety and Depression Scale (HADS). The scale icludes two subscales one focusing on anxiety symptoms and one on depressive symptoms. The minimum value is 0 and the maximum value is 21 for each subscale. Higher scores means worse outcome.
Change from baseline in anxiety and depression to the end of the rehab program (average four month)
Changes in sleep
大体时间:Change from baseline in Insomnia Severity Index to the end of the rehab program (average four month)
Changes in Insomnia measured with Insomnia Severity Index (ISI). The minimum value is 0 and the maximum value is 28. Higher scores indicates a worse outcome.
Change from baseline in Insomnia Severity Index to the end of the rehab program (average four month)
Changes in sleep
大体时间:Change from baseline in Insomnia Severity Index through study completion (average 1,5 years)
Changes in sleep measured with Insomnia Severity Index (ISI). The minimum value is 0 and the maximum value is 28. Higher scores indicates a worse outcome.
Change from baseline in Insomnia Severity Index through study completion (average 1,5 years)
Changes in Life satisfaction
大体时间:Change from baseline in Life Satisfaction Questionnaire to the end of the rehab program (average four month)
Changes in Life Satisfaction measured with Life Satisfaction Questionnaire (Li-Sat-11). Minimum score at 11 and maximum score at 66. Higher scores indicate a greater level of perceived satisfaction.
Change from baseline in Life Satisfaction Questionnaire to the end of the rehab program (average four month)
Changes in Life satisfaction
大体时间:Change from baseline in Life Satisfaction Questionnaire through study completion (average 1,5 years)
Changes in Life Satisfaction measured with Life Satisfaction Questionnaire (Li-Sat-11). Minimum score at 11 and maximum score at 66. Higher scores indicate a greater level of perceived satisfaction.
Change from baseline in Life Satisfaction Questionnaire through study completion (average 1,5 years)
Changes in Work ability
大体时间:Change from baseline in Work ability to the end of the rehab program (average four month)
Changes in work ability measured with the 7:th question in Work Ability Index questionnaire
Change from baseline in Work ability to the end of the rehab program (average four month)
Changes in Work ability
大体时间:Change from baseline in Work ability through study completion (average 1,5 years)
Changes in work ability measured with the 7:th question in Work Ability Index questionnaire
Change from baseline in Work ability through study completion (average 1,5 years)
Changes in health-related quality of life
大体时间:Change from baseline in RAND-36 to the end of the rehab program (average four month)
Changes in health-related quality of life measured with RAND-36. The RAND-36 consists of 36 items grouped into eight multi-item scales: physical functioning (PF), role-functioning/physical (RP), pain (P), general health (GH), energy/fatigue (EF), social functioning (SF), role-functioning/emotional (RE), and emotional well-being (EW). An additional item asks about health change (HC) in the past year. Scale scores are summed and transformed into scales ranging from 0 (worst possible health state) to 100 (best possible state).
Change from baseline in RAND-36 to the end of the rehab program (average four month)
Changes in health-related quality of life
大体时间:Change from baseline in RAND-36 through study completion (average 1,5 years)
Changes in health-related quality of life measured with RAND-36. The RAND-36 consists of 36 items grouped into eight multi-item scales: physical functioning (PF), role-functioning/physical (RP), pain (P), general health (GH), energy/fatigue (EF), social functioning (SF), role-functioning/emotional (RE), and emotional well-being (EW). An additional item asks about health change (HC) in the past year. Scale scores are summed and transformed into scales ranging from 0 (worst possible health state) to 100 (best possible state).
Change from baseline in RAND-36 through study completion (average 1,5 years)

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

  • 首席研究员:Therese Hellman, PhD、Uppsala University

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 (实际的)

2019年6月20日

初级完成 (预期的)

2022年12月20日

研究完成 (预期的)

2023年12月20日

研究注册日期

首次提交

2019年7月16日

首先提交符合 QC 标准的

2021年10月1日

首次发布 (实际的)

2021年10月15日

研究记录更新

最后更新发布 (实际的)

2021年11月8日

上次提交的符合 QC 标准的更新

2021年10月29日

最后验证

2021年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2019/01755

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

Requirements and functional Schedule的临床试验

3
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