Measuring the Impact of Taking Care in the Context of an Innovative System for Keeping Dependent Elderly People in Their Homes

NCT ID: NCT03976661

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2024-04-26

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)

Conditions

Patient With no Severe Behavioural Disorders and Whose Situation Would Require Entry Into Classique EHPAD (Retirement Home)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

DIAPASON 92 arm

Arm will be constitued by older patients with loss of autonomy, living at home benefiting from the device DIAPASON 92 (Innovative support system for elderly people in their homes)

No interventions assigned to this group

Control arm

Arm will be constituted by people residing at the EHPAD (retirement home)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥ 60 years old.
• (Group iso-resources) GIR ≤ 4
• Beneficiary of treatment by Diapason 92 or resident at EHPAD Aulagnier for more than 6 months.
• Not exhibiting severe disruptive behaviour disorders (on NPI-ES all FXG 12 and resonance 4 scores).
• Affiliate or entitled to a sickness insurance scheme
• Patient or legal representative expressed no objection

• Exercise within Diapason 92 device or be identified as assisting a Diapason 92 user or be a professional partner of Diapason 92 device
• Have expressed no objection to participating in the study.

Exclusion Criteria

• Age < 60 years old
• GIR ˃ 4
• Not affiliated or entitled to a sickness insurance scheme
• Patient or legal representative did not express no objection

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gérond'if

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier Phd Hanon

Role: PRINCIPAL_INVESTIGATOR

Geriatric department, Broca hospital (Paris)

Locations

Geriatric department , Broca Hospital

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Isabelle Dufour

Role: CONTACT

isabelle.dufour@gerondif.org

+33 (0) 185781010

Prisca Lucas, PhD

Role: CONTACT

prisca.lucas@gerondif.org

+33 (0) 185781010

Facility Contacts

Agathe Raynaud-Simon

Role: primary

agathe.raynaud-simon@aphp.fr

140257369

Other Identifiers

2018-A03183-52

Identifier Type: -

Identifier Source: org_study_id