跳至主要内容
临床试验/NCT06344676
NCT06344676尚未招募不适用

Estudi de l'Impacte de la Soledat no Volguda Incorporant un Robot Social en Centres Residencials

Sara Domenech0 个研究点目标入组 162 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
162
主要终点
Loneliness

研究概览

简要总结

The goal of this clinical trial is to assess the usefulness of social robots reducing unwanted loneliness in persons over 65 living in nursing homes. The main questions it aims to answer are:

  • Can social robots reduce unwanted loneliness?
  • Can social robots improve quality of live and well-being? The selected centers are organized in several classes of living units. Living units are independent physical spaces with their own common facilities for the persons living in (usually around 15). Living units of the same class gather persons with similar characteristics.

To compare the added value of the robots half of the living units will be allocated to a control group, and the other half to the intervention group.

The persons in living units allocated to the control group will receive the same attentions and care which were receiving before the enrollment in the study, whereas the persons allocated to the intervention group will add a social robot to their usual therapies and activities. Namely participants will do three weekly individual cognitive stimulation sessions of 10 minutes each one, two weekly group mobility sessions of 30 minutes, one monthly conversational group about customs and traditions of 60 minutes, one 10 minutes videoconference per month with their relatives. Furthermore, participants will be able to interact freely with the robot to obtain information about the center (for instance, what is for dinner) and its activities.

The intervention will last 8 weeks. To assess the effectivity, the investigators will assess both groups, before the intervention, at the end of the intervention and 4 weeks after finishing the intervention.

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

  • To be 65 years old or older.
  • To live indefinitely for more than 6 months in the participating nursing home (to avoid the effect of the adaptation period).
  • Provide the informed consent.

排除标准

  • Impossibility to understand and/or answer the loneliness questionnaire for themselves.
  • To have physical, cognitive or other conditions preventing the use of the robot platform.

结局指标

主要结局

Loneliness

时间窗: weeks 0, 8 and 12

Change in the UCLA Loneliness Scale (Version 3). The UCLA Loneliness Scale is a 20-item scale (Russell, 1996) that includes statements (e.g., How often do you feel alone?) rated on a four-point Likert scale ranging from 1 (never) to 4 (always). The total score ranges from 20 to 80. Higher scores indicate greater degrees of loneliness.

次要结局

  • Depressive symptoms(weeks 0, 8 and 12)
  • Social Support(weeks 0, 8 and 12)
  • Well-being(weeks 0, 8 and 12)
  • Communication(weeks 0, 8 and 12)
  • Quality of life, irrespective of the disease(weeks 0, 8 and 12)
  • Satisfaction with life(weeks 0, 8 and 12)

研究者

发起方
Sara Domenech
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sara Domenech

Researcher

Fundacio Salut i Envelliment UAB

相似试验