Study of the Impact of a Social Telepresence Robot on Social Isolation and Loneliness of the Elderly at Home (DOMIROB)

February 19, 2021 updated by: Gérond'if
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

Study Overview

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Île-de-France
      • Paris, Île-de-France, France, 75013
        • Recruiting
        • Living Lab Department, Broca Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elderly subjects living at home, volunteers, divided into 6 groups of 10 people. This represents a simultaneous implementation of 10 robots at home.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measuring subjective feelings of loneliness as well as feelings of social isolation according the UCLA Loneliness Scale
Time Frame: 24 weeks
24 weeks
Measuring the perception of social support according Multidimensional Scale of Perceived Social Support
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Measuring the perceived usability of the robot's software according the System Usability Scale
Time Frame: 24 weeks
24 weeks
Measuring technology acceptance according ALMERE questionnaire
Time Frame: 12 weeks
12 weeks
Assessment of the impact of health according 12-Item Short Form Survey (SF-12) scale
Time Frame: 24 weeks
24 weeks
Assessment of depressive state according Geriatric Depression Scale
Time Frame: 24 weeks
24 weeks
Assessment positive and negative affect according the Positive Affect Negative Affect Scale (PANAS)
Time Frame: 24 weeks
24 weeks
Assessment of the psycho-social impact of the device technology on the lives of users according The Psychosocial Impact of Assistive Devices Scales (PIADS)
Time Frame: 12 weeks
12 weeks
Measuring the dimensions of the telepresence according Telepresence Temple Presence Inventory (TPI)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Anne-Sophie RIGAUD, MD PhD, Living Lab Department, Broca Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

February 19, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 19, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-A00381-38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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