Acceptability Study of Sensor in Elderly People's House L... | NCT04763811

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

NCT04763811

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Last Update Posted

Feb 21, 2021Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Aging

Interventions

Focus groups
Individual interviews

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Apr 1, 2020Actual

Completion Date

Oct 1, 2020Actual

First Submitted Date

Feb 17, 2021

First Submission Date that Met QC Criteria

Feb 17, 2021

First Posted Date

Feb 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2021

Last Update Posted Date

Feb 21, 2021Actual

Name	Class
Saint Etienne School of Mine	OTHER
Eovi Mcd Mutuelle	UNKNOWN
Gerontopole Auvergne Rhone-Alpes (AURA)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This research tend to study the acceptability of captors which can measure the evolution of autonomy of older 65 people.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 Other: Individual interviews

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Focus groups	Other	discussion between participants about representations of health, dependance, fragility, and new technologies	Older 65 people

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis representations of health/fragility and new technologies	Measured by focus groups results.	Months:6

Secondary Outcomes

Measure	Description	Time Frame
Analysis Representations of health and frailties ; and new technologies Acceptability of sensors	Measured by individual interviews results.	Months:6

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

People living alone
Autonomous person

Exclusion Criteria:

Person with a neurological disease
Person under guardianship or curatorship

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Older 65 people who live alone in their own house

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vincent Augusto	augusto@emse.fr	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gérontopole AURA		Saint-Etienne			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017144	Focus Groups

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided