- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04767100
Study of the Impact of a Social Telepresence Robot on Social Isolation and Loneliness of the Elderly at Home (DOMIROB)
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Isabelle Dufour
- Phone Number: +33 (0)185781010
- Email: isabelle.dufour@gerondif.org
Study Contact Backup
- Name: Adrien Besseiche
- Phone Number: +33 (0)185781010
- Email: adrien.besseiche@gerondif.org
Study Locations
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Île-de-France
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Paris, Île-de-France, France, 75013
- Recruiting
- Living Lab Department, Broca Hospital
-
Contact:
- Anne-Sophie RIGAUD, MD PhD
- Phone Number: +33(0)144083517.
- Email: anne-sophie.rigaud@aphp.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Study Chair: Anne-Sophie RIGAUD, MD PhD, Living Lab Department, Broca Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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