AgingNCT04763811
Acceptability Study of Sensor in Elderly People's House Living Alone (Fragility Box)
An observational study of Aging, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The Fragility box is a project lead by Mines de Saint-Etienne, Gérontopôle Auvergne-Rhône-Alpes (AURA) and Eovi Mcd Mutually to prevent autonomy loss in the elderly dwelling population. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Focus groups and Individual interviews
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 1 Oct 2020
- 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: Older 65 people who live alone in their own house
Who may be able to join
- People living alone
- Autonomous person
Who cannot join
- Person with a neurological disease
- Person under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability Study of Sensor in Elderly People's House Living Alone
The Fragility box is a project lead by Mines de Saint-Etienne, Gérontopôle Auvergne-Rhône-Alpes (AURA) and Eovi Mcd Mutually to prevent autonomy loss in the elderly dwelling population. With non-intrusive sensors installed in their residence, it is possible to monitor and forecast the frail state of elderly people living alone. The current study focuses on the technical feasibility of the project and the acceptability of these types of devices within the elderly's home. About ten participants have volunteered to be a part of this study. Therefore, they had the sensors installed at their home for a 12 months duration. A qualitative study with focus groups and individual interviews are carried out to evaluate the project: user satisfaction, expectations, and fears.
Read the detailed description
This research tend to study the acceptability of captors which can measure the evolution of autonomy of older 65 people.
- Conditions
- Aging
- Being tested
- Focus groups, Individual interviews
- Keywords
- sensors, acceptability, qualitative study, autonomous, elderly people, prevention, Autonomy loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupsOther
discussion between participants about representations of health, dependance, fragility, and new technologies
Individual interviewsOther
Discussion between the searcher and the participant about representations of captors, discretion of captors, wish about feed-backs of captors
| Study group | Role | What they receive |
|---|---|---|
| Older 65 people | Older 65 people who live alone in their house will be included. They will have focus groups and Individual interviews. Receives: Other: Focus groups; Other: Individual interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis representations of health/fragility and new technologies
Measured by focus groups results.
Measured: Months:6
Secondary outcomes (1)
Analysis Representations of health and frailties ; and new technologies Acceptability of sensors
Measured by individual interviews results.
Measured: Months:6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Mar 2020
- Primary completion1 Apr 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Etienne School of Mine, Eovi Mcd Mutuelle, Gerontopole Auvergne Rhone-Alpes (AURA)
- Responsible party
- Sponsor
- Investigators
- Vincent Augusto, Study director, augusto@emse.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763811
- Sponsor's protocol ID
- GA-2021-01
- Status last verified
- Feb 2021
- First submitted
- 17 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability Study of Sensor in Elderly People's House Living Alone
- ClinicalTrials.gov ID
- NCT04763811
- Acronym / sponsor ID
- GA-2021-01
- Conditions
- Aging
- Keywords
- sensors, acceptability, qualitative study, autonomous, elderly people, prevention, Autonomy loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Saint Etienne School of Mine, Eovi Mcd Mutuelle, Gerontopole Auvergne Rhone-Alpes (AURA)
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 21 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 Fragility box is a project lead by Mines de Saint-Etienne, Gérontopôle Auvergne-Rhône-Alpes (AURA) and Eovi Mcd Mutually to prevent autonomy loss in the elderly dwelling population. With non-intrusive sensors installed in their residence, it is possible to monitor and forecast the frail state of elderly people living alone. The current study focuses on the technical feasibility of the project and the acceptability of these types of devices within the elderly's home. About ten participants have volunteered to be a part of this study. Therefore, they had the sensors installed at their home for a 12 months duration. A qualitative study with focus groups and individual interviews are carried out to evaluate the project: user satisfaction, expectations, and fears.
Detailed description
This research tend to study the acceptability of captors which can measure the evolution of autonomy of older 65 people.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older 65 people | – | Other: Focus groups, Other: Individual interviewsOlder 65 people who live alone in their house will be included. They will have focus groups and Individual interviews. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Older 65 people who live alone in their own house
Key inclusion criteria (2 listed)
- People living alone
- Autonomous person
Key exclusion criteria (2 listed)
- Person with a neurological disease
- Person under guardianship or curatorship
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 |
|---|---|---|
| Focus groupsdiscussion between participants about representations of health, dependance, fragility, and new technologies | Other | Older 65 people |
| Individual interviewsDiscussion between the searcher and the participant about representations of captors, discretion of captors, wish about feed-backs of captors | Other | Older 65 people |
Primary outcome
Analysis representations of health/fragility and new technologies
Time frame: Months:6
Measured by focus groups results.
1 secondary outcome
Analysis Representations of health and frailties ; and new technologies Acceptability of sensors
Time frame: Months:6
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 21 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Vincent Augusto study director
augusto@emse.fr
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 Aging, run by Centre Hospitalier Universitaire de Saint Etienne 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 2 inclusion and 2 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 21 Feb 2021. 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?
Analysis representations of health/fragility and new technologies (time frame: Months:6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2021.