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临床试验/NCT04570813
NCT04570813已完成不适用

Art'Health: Effects of Artistic and Participative Workshops at the MAMAC of Nice on the Health of Seniors

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2021年1月18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
127
试验地点
2
主要终点
changes of well being level

研究概览

简要总结

Study with two arms, one of which receives an intervention in the form of participative artistic workshops at the MAMAC and the other was assigned as the control group. Well-being, Quality of life, Health, Apathy and Olfactory identification scales are proposed before the intervention, during the intervention at the end of each month (M1, M2, M3), 6 months after the end of the intervention (M9) and 12 months after the end of the intervention (M15).

研究设计

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

入排标准

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

入选标准

  • Be 65 years of age at the time of signing the consent,
  • Having internet access and an electronic tool (smartphone and/or tablet) at home as repeated assessments will be proposed on a dedicated and secure internet platform,
  • To master the French language,
  • To be available during participatory workshop sessions at MAMAC.
  • Be affiliated to Social Security

排除标准

  • Do not master the French language,
  • Severe sensory and/or cognitive impairment identified by the IP and their representatives during the inclusion interview,
  • Person under guardianship, curatorship or safeguarding of justice,
  • Person unable to give or sign consent.

结局指标

主要结局

changes of well being level

时间窗: before the intervention, during the intervention at the end of each month (Month1, Month 2, Month 3), 6 months after the end of the intervention (Month 9) and 12 months after the end of the intervention (Month 15)

well being scale assessment Warwick-Edimbourg Mental Well-Being State (WEMWBS) maximum value : 70 (better outcome) minimum value :14 (worse outcome)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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