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Acceptability Study of Sensor in Elderly People's House Living Alone (Fragility Box)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04763811
Recruitment Status : Completed
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Collaborators:
Ecole des Mines de Saint-Etienne
Eovi Mcd Mutuelle
Gerontopole Auvergne Rhone-Alpes (AURA)
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Aging Other: Focus groups Other: Individual interviews

Detailed Description:
This research tend to study the acceptability of captors which can measure the evolution of autonomy of older 65 people.
Study Design
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acceptability Study of Sensor in Elderly People's House Living Alone
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : October 1, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Older 65 people
Older 65 people who live alone in their house will be included. They will have focus groups and Individual interviews.
 Other: Focus groups
discussion between participants about representations of health, dependance, fragility, and new technologies

Other: Individual interviews
Discussion between the searcher and the participant about representations of captors, discretion of captors, wish about feed-backs of captors


Outcome Measures
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Primary Outcome Measures :
  1. Analysis representations of health/fragility and new technologies [ Time Frame: Months:6 ]
    Measured by focus groups results.


Secondary Outcome Measures :
  1. Analysis Representations of health and frailties ; and new technologies Acceptability of sensors [ Time Frame: Months:6 ]
    Measured by individual interviews results.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Older 65 people who live alone in their own house
Criteria

Inclusion Criteria:

  • People living alone
  • Autonomous person

Exclusion Criteria:

  • Person with a neurological disease
  • Person under guardianship or curatorship
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763811


Locations
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France
Gérontopole AURA
Saint-Étienne, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ecole des Mines de Saint-Etienne
Eovi Mcd Mutuelle
Gerontopole Auvergne Rhone-Alpes (AURA)
Investigators
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Study Director: Vincent Augusto augusto@emse.fr
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04763811    
Other Study ID Numbers: GA-2021-01
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
sensors
acceptability
qualitative study
autonomous
 elderly people
prevention
Autonomy loss