Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
Study NCT ID:
NCT03976661
Status:
UNKNOWN
Last Update Posted:
2023-01-12
First Post:
2019-06-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measuring the Impact of Taking Care in the Context of an Innovative System for Keeping Dependent Elderly People in Their Homes
Sponsor:
Gérond'if
Organization:
Study Overview
Official Title:
Measuring the Impact of Taking Care in the Context of an Innovative System for Keeping Dependent Elderly People in Their Homes
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIAPASON
Brief Summary:
The purpose of this study is to compare life quality of patients taking care by DIAPASON 92 with patients or residents from control group EHPAD (retirement home)
Detailed Description:
This study has two components: a quantitative component(for users and caregivers) and a qualitative component (for users, caregivers and professionals)
About population :
For quantitative component: the investigators have two arms:
* Diapason 92 arm: will be constitued by older patients with loss of autonomy, living at home and benefiting from Diapason 92 device
* Control arm: will be constituted by people residing at the EHPAD (retirement home)
For qualitative component: Study will cover 5 different populations since it concerns both:- - Diapason 92 professionals who work directly with users
* Daipason 92 Supervisory staff
* Diapason 92 professional partners, including referring physicians.
* The users
* Non-professional helpers of users
Conduct of study:
\- About quantitative component:
After verification of eligibility criteria adapted to each centre and once the non-opposition has been collected and subjects have been included, the following data will be collected at M0, M3, M6 and M12:
* For patients : Start date of care by Diapason 92 or EHPAD, Quality of Life score, benefit evaluation, Socio-educational level, evaluation of disruptive behaviour disorders, economic indicators, somatic comorbidities, collection of psychiatric follow-up if available, independence, nutritional status, factors(s) that motivated care, cognitive assessment, balance assessment, depression screening, ergonomic assessment (only for Diapason 92
* Family caregiver: 3 measures will be collected: Measuring the burden by Zarit scale, self-assessment of his quality of life and psychological condition
* About quality component:
A socio-demographic heel will be collected for each participant interviewed who has given no objection to participating in the study. His agreement on the recording of his voice will also collected.
For all participants, following data will be collected: Age, sex, occupation, date and duration of the interview, relationship with the Diapason 92 user (for family caregivers) and the recovery of socio-demographic data of the case report form (for users)
About population :
For quantitative component: the investigators have two arms:
* Diapason 92 arm: will be constitued by older patients with loss of autonomy, living at home and benefiting from Diapason 92 device
* Control arm: will be constituted by people residing at the EHPAD (retirement home)
For qualitative component: Study will cover 5 different populations since it concerns both:- - Diapason 92 professionals who work directly with users
* Daipason 92 Supervisory staff
* Diapason 92 professional partners, including referring physicians.
* The users
* Non-professional helpers of users
Conduct of study:
\- About quantitative component:
After verification of eligibility criteria adapted to each centre and once the non-opposition has been collected and subjects have been included, the following data will be collected at M0, M3, M6 and M12:
* For patients : Start date of care by Diapason 92 or EHPAD, Quality of Life score, benefit evaluation, Socio-educational level, evaluation of disruptive behaviour disorders, economic indicators, somatic comorbidities, collection of psychiatric follow-up if available, independence, nutritional status, factors(s) that motivated care, cognitive assessment, balance assessment, depression screening, ergonomic assessment (only for Diapason 92
* Family caregiver: 3 measures will be collected: Measuring the burden by Zarit scale, self-assessment of his quality of life and psychological condition
* About quality component:
A socio-demographic heel will be collected for each participant interviewed who has given no objection to participating in the study. His agreement on the recording of his voice will also collected.
For all participants, following data will be collected: Age, sex, occupation, date and duration of the interview, relationship with the Diapason 92 user (for family caregivers) and the recovery of socio-demographic data of the case report form (for users)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: