Measuring the Impact of Taking Care in the Context of an Innovative System for Keeping Dependent Elderly People in Their Homes (DIAPASON)
Study Overview
Status
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)
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Isabelle Dufour
- Phone Number: +33 (0) 185781010
- Email: isabelle.dufour@gerondif.org
Study Contact Backup
- Name: Prisca Lucas, PhD
- Phone Number: +33 (0) 185781010
- Email: prisca.lucas@gerondif.org
Study Locations
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Ile-de-France
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Paris, Ile-de-France, France, 75013
- Recruiting
- Geriatric department , Broca Hospital
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Contact:
- Agathe Raynaud-Simon
- Phone Number: 140257369
- Email: agathe.raynaud-simon@aphp.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
For quantitative component: we 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
Description
Patient/Resident 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
Patient/Resident 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
Professionals and caregivers Inclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
|---|
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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)
|
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Control arm
Arm will be constituted by people residing at the EHPAD (retirement home)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of life quality according Nottingham Health Profile (NHP) scale
Time Frame: 12 months
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Difference in 12-month quality of life scores (Nottingham Health Profile) between the 2 groups (Diapason 92 and EHPAD).
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessment of the level of loss of autonomy of an elderly people according Autonomy, gerontology Iso Resources Group (AGGIR) scale
Time Frame: 12 months
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12 months
|
|
Assessment of functional status according Lawton Instrumental Activities of Daily Living (IADL) Scale
Time Frame: 12 months
|
12 months
|
|
Assessment of activities of daily living, self-care, and independence according Activities of Daily Living (ADL) Scale
Time Frame: 12 months
|
12 months
|
|
Assessment of comorbidity according Charlson scale
Time Frame: 12 months
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12 months
|
|
Assessment of cognitive function according Mini-Mental State Examination (MMSE) scale
Time Frame: 12 months
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12 months
|
|
Assessment of disorders of disruptive behaviour according (NPI-ES) scale
Time Frame: 12 months
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12 months
|
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Assessment of geriatric depression according Geriatric Depression Scale (GDS) scale
Time Frame: 12 months
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12 months
|
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Measuring of burden of the close caregivers according Popular Caregiver Self-report measure Burden (ZARIT)
Time Frame: 12 months
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12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olivier Phd Hanon, Geriatric department, Broca hospital (Paris)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-A03183-52
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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