NCT04763811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

1 month

First QC Date

February 17, 2021

Last Update Submit

February 17, 2021

Conditions

Keywords

sensorsacceptabilityqualitative studyautonomouselderly peoplepreventionAutonomy loss

Outcome Measures

Primary Outcomes (1)

  • Analysis representations of health/fragility and new technologies

    Measured by focus groups results.

    Months:6

Secondary Outcomes (1)

  • Analysis Representations of health and frailties ; and new technologies Acceptability of sensors

    Months:6

Study Arms (1)

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 groupsOther: Individual interviews

Interventions

discussion between participants about representations of health, dependance, fragility, and new technologies

Older 65 people

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

Older 65 people

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Older 65 people who live alone in their own house

You may qualify if:

  • People living alone
  • Autonomous person

You may not qualify if:

  • Person with a neurological disease
  • Person under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gérontopole AURA

Saint-Etienne, France

Location

MeSH Terms

Interventions

Focus Groups

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Vincent Augusto

    augusto@emse.fr

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 21, 2021

Study Start

March 1, 2020

Primary Completion

April 1, 2020

Study Completion

October 1, 2020

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations