NCT04767100

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2021

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2021

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

February 19, 2021

Last Update Submit

February 2, 2023

Conditions

Keywords

Elderly peopleLiving at homeInternet connection

Outcome Measures

Primary Outcomes (2)

  • Measuring subjective feelings of loneliness as well as feelings of social isolation according the UCLA Loneliness Scale

    24 weeks

  • Measuring the perception of social support according Multidimensional Scale of Perceived Social Support

    24 weeks

Secondary Outcomes (7)

  • Measuring the perceived usability of the robot's software according the System Usability Scale

    24 weeks

  • Measuring technology acceptance according ALMERE questionnaire

    12 weeks

  • Assessment of the impact of health according 12-Item Short Form Survey (SF-12) scale

    24 weeks

  • Assessment of depressive state according Geriatric Depression Scale

    24 weeks

  • Assessment positive and negative affect according the Positive Affect Negative Affect Scale (PANAS)

    24 weeks

  • +2 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Living Lab Department, Broca Hospital

Paris, Île-de-France Region, 75013, France

Location

Related Publications (1)

  • Isabet B, Rigaud AS, Li W, Pino M. Telepresence Robot Intervention to Reduce Loneliness and Social Isolation in Older Adults Living at Home (Project DOMIROB): Protocol for a Clinical Nonrandomized Study. JMIR Res Protoc. 2022 Oct 31;11(10):e40528. doi: 10.2196/40528.

Study Officials

  • Anne-Sophie RIGAUD, MD PhD

    Living Lab Department, Broca Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 23, 2021

Study Start

September 24, 2020

Primary Completion

July 8, 2021

Study Completion

July 29, 2021

Last Updated

February 3, 2023

Record last verified: 2023-02

Locations