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临床试验/NCT05089799
NCT05089799已完成不适用

" Socially Pertinent Robot in Gerontological Healthcare "

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2022年10月20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
115
试验地点
1
主要终点
Acceptability E-Scale (AE-S)

研究概览

简要总结

The SPRING project intends to develop a social assistance robot, called ARI, capable of interacting with several users (patients, families) in noisy and busy hospital environments to inform, guide and entertain them and to support care workers in these environments. The AP-HP researchers participating in the SPRING project wish to evaluate human-robot interactions in a day care hospital and in particular the acceptability and the uses of the robot.

详细描述

Elderly people suffering from neurocognitive disorders require multimodal support (social, medical, associative) in which Socially Assistive Robots (SARs) could intervene in order to improve the physical and psychological well-being of elderly people and maintain their quality of life. SARs are social entities capable of interacting with their users in a variety of contexts (informational, recreational, educational). These robots also offer promising possibilities for accompanying care workers in their support of people with neurodegenerative diseases. However, up to date, these robots are not sufficiently sophisticated to engage in satisfactory social interactions with human beings and lead to their adoption.

The SPRING study is a non-interventional study that does not include objectives for improving health or patient care. It is an exploratory study targeting five use cases with a social robot and three populations of care hospital users (patients, informal or family caregivers and professionals). No follow-up of the participants is necessary.

The main objective of SPRING is to study the acceptability of socially assistive robots among three actors in a hospital service: patients, informal or family caregivers and professionals. The secondary objectives are to study a) the usability of the ARI robot among day care hospital's users which is necessary to understand the efficiency of using the robot in this context; b) the organisational impact of the robot on the operation of the service among day care hospital's professionals ; c) the ethical questions generated by the presence of the robot with the participants that will allow us to extend our understanding of the determinants of the rejection or adoption of new technologies in the hospital context.

During this non-interventional and exploratory research, the ARI robot will be tested in the waiting room of a day care hospital in a geriatric hospital regarding five use cases (1/welcoming patients and family members to the hospital, 2/ providing a reminder how to follow sanitary gestures for the prevention of virus transmission, 3/providing patients an assistance to prepare for the medical consultation that will follow during the day, 4/ providing orientation and guidance in relation to the location (hospital) and the services available (toilets, cafeteria, elevators, etc.) and 5/Providing entertainment to patients and families during the waiting time.

Patients and their family caregivers meet the robot only once. They answer questionnaires and participate in semi-structured interviews after interacting with the robot. Evaluations target the acceptability, usability and ethical issues raised by the presence of a robotic agent in support of care teams.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • Age 60 and over
  • Enough knowledge in French language
  • Without distinction of gender, socio-professional categories or ethnic origin
  • MMSE > 10
  • No symptoms of altered reality (delirium, hallucination, frontal disinhibition, etc.).
  • Having expressed his/her non-opposition to his/her participation in the study or to being in the presence of the robot
  • If the persons are protected adults under guardianship, the tutor or legal guardian has expressed his/her non-opposition to participate in the study or to be in the presence of the robot for the person concerned.
  • ACCOMPANYING PERSONS
  • They are all adults who have enough knowledge in French language.
  • They are enrolled without distinction of gender, socio-professional categories or ethnic origin
  • They have expressed his/her non-opposition to participate in the study
  • PROFESSIONALS:
  • Age 18 and over.
  • Has expressed his/her non-opposition to participate in the study

排除标准

  • They have expressed, or where applicable, their family, guardian or legal representative, their opposition to participate in the study or their opposition to be in the presence of the robot.
  • PAtients benefiying of Medical State Aid (French AME)
  • ACCOMPANYING PERSONS They are under
  • They do not have enough knowledge in French language to understand simple instructions. They have expressed their opposition to participate in the study or their opposition to be in the presence of the robot.
  • PROFESSIONNALS They have expressed their opposition to participate in the study or their opposition to be in the presence of the robot.

结局指标

主要结局

Acceptability E-Scale (AE-S)

时间窗: Inclusion visit

This criterion will be evaluated with patients, informal or family caregivers and professionals, on the basis of the French version of the "Acceptability E-Scale" (AE-S), a six items questionnaire rated with a Likert scale from 1 to 5 (Micoulaud-Franchi et al., 2016). The items have been adapted for a use with a robot. On the day of the appointment at the day care hospital for patients and their informal or family caregivers. During the experiment for professionals. One session, approximatively 10 minutes length.

次要结局

  • Semi-structured interview (10 questions) based on the USUS model (Hebesberger et al., 2017)(Inclusion visit)
  • Semi-structured interview (6 questions)(Inclusion visit)
  • System Usability Scale (SUS)(Inclusion visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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