Elderly People Living at HomeDOMIROBNCT04767100
Study of the Impact of a Social Telepresence Robot on Social Isolation and Loneliness of the Elderly at Home
An observational study of Elderly People Living at Home and With an Internet Connection at Home, run by Gérond'if at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly People Living at Home, With an Internet Connection at Home
- What is being tested?
- Social telepresence robot
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2020to 29 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Living Lab Department, Broca Hospital
Paris, Île-de-France Region, 75013
About this study
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
Read the 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.
- Being tested
- Social telepresence robot
- Keywords
- Elderly people, Living at home, Internet connection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social telepresence robotDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring subjective feelings of loneliness as well as feelings of social isolation according the UCLA Loneliness Scale
Measured: 24 weeks
Measuring the perception of social support according Multidimensional Scale of Perceived Social Support
Measured: 24 weeks
Secondary outcomes (7)
Measuring the perceived usability of the robot's software according the System Usability Scale
Measured: 24 weeks
Measuring technology acceptance according ALMERE questionnaire
Measured: 12 weeks
Assessment of the impact of health according 12-Item Short Form Survey (SF-12) scale
Measured: 24 weeks
Assessment of depressive state according Geriatric Depression Scale
Measured: 24 weeks
Assessment positive and negative affect according the Positive Affect Negative Affect Scale (PANAS)
Measured: 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)
Measured: 12 weeks
Measuring the dimensions of the telepresence according Telepresence Temple Presence Inventory (TPI)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start24 Sep 2020
- Primary completion8 Jul 2021
- Study completion29 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elderly People Living at HomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Sophie RIGAUD, MD PhD, Study chair, Living Lab Department, Broca Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767100
- Sponsor's protocol ID
- 2020-A00381-38
- Acronym
- DOMIROB
- Status last verified
- Feb 2023
- First submitted
- 19 Feb 2021
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36315231
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of a Social Telepresence Robot on Social Isolation and Loneliness of the Elderly at Home
- ClinicalTrials.gov ID
- NCT04767100
- Acronym / sponsor ID
- DOMIROB / 2020-A00381-38
- Keywords
- Elderly people, Living at home, Internet connection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social telepresence robotUse 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. | Device | – |
Primary outcome
Measuring subjective feelings of loneliness as well as feelings of social isolation according the UCLA Loneliness Scale
Time frame: 24 weeks
Measuring the perception of social support according Multidimensional Scale of Perceived Social Support
Time frame: 24 weeks
7 secondary outcomes
Measuring the perceived usability of the robot's software according the System Usability Scale
Time frame: 24 weeks
Measuring technology acceptance according ALMERE questionnaire
Time frame: 12 weeks
Assessment of the impact of health according 12-Item Short Form Survey (SF-12) scale
Time frame: 24 weeks
Assessment of depressive state according Geriatric Depression Scale
Time frame: 24 weeks
Assessment positive and negative affect according the Positive Affect Negative Affect Scale (PANAS)
Time frame: 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
Measuring the dimensions of the telepresence according Telepresence Temple Presence Inventory (TPI)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Derived from this study: PubMed 36315231Isabet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Sophie RIGAUD, MD PhD study chair
Living Lab Department, Broca Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly People Living at Home and With an Internet Connection at Home, run by Gérond'if at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring subjective feelings of loneliness as well as feelings of social isolation according the UCLA Loneliness Scale (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04767100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.