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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04767100
Other study ID # 2020-A00381-38
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 24, 2020
Est. completion date July 29, 2021

Study information

Verified date February 2023
Source Gérond'if
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main purpose of this monocentric, prospective study is to measure the impact of the implementation of a robotic social telepresence tool, during three months at home, on the feeling of loneliness and social isolation of the elderly


Description:

This non-interventional and prospective study offers elderly people living at home the opportunity to host a social telepresence robot, for a period of three months, with the aim of maintaining a link with those around them and discovering activities offered by professionals (cooking, yoga, visiting virtual museum, etc.) via a networking platform. This study consists of questionnaires and score calculations, assessing their feeling of loneliness and how they accept the robot in their home. Subjects will be interviewed one week before the robot arrives at their home, at the start of the study (when the robot arrives). The follow-up is carried out by a neuropsychologist at 6, 12 and 24 weeks of presence at home. Data measuring loneliness and social isolation, memory, patient interaction with the robot, their quality of life as well as their emotions will be collected using questionnaires.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date July 29, 2021
Est. primary completion date July 8, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Subjects aged at least 65 and living at home in Ile-de-France - Having expressed his non-opposition to his participation in the study - Agreeing to host a social telepresence robot at home - Having an internet connection at home Exclusion Criteria: - Subject aged under 65 or not living at home in Ile-de-France - Having expressed his opposition to his participation in the study - With moderate / major cognitive impairment (Mini-mental state examination (MMSE) <20) - Placed under tutorship / curatorship - Whose housing surface is insufficient for reception and robot movements

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Social telepresence robot
Use of a social telepresence robot at home, during three months with the aim of reducing the feeling of loneliness and social isolation among the elderly.

Locations

Country Name City State
France Living Lab Department, Broca Hospital Paris Île-de-France

Sponsors (1)

Lead Sponsor Collaborator
Gérond'if

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measuring subjective feelings of loneliness as well as feelings of social isolation according the UCLA Loneliness Scale 24 weeks
Primary Measuring the perception of social support according Multidimensional Scale of Perceived Social Support 24 weeks
Secondary Measuring the perceived usability of the robot's software according the System Usability Scale 24 weeks
Secondary Measuring technology acceptance according ALMERE questionnaire 12 weeks
Secondary Assessment of the impact of health according 12-Item Short Form Survey (SF-12) scale 24 weeks
Secondary Assessment of depressive state according Geriatric Depression Scale 24 weeks
Secondary Assessment positive and negative affect according the Positive Affect Negative Affect Scale (PANAS) 24 weeks
Secondary Assessment of the psycho-social impact of the device technology on the lives of users according The Psychosocial Impact of Assistive Devices Scales (PIADS) 12 weeks
Secondary Measuring the dimensions of the telepresence according Telepresence Temple Presence Inventory (TPI) 12 weeks