Patient With no Severe Behavioural Disorders and Whose Situation Would Require Entry Into Classique EHPAD (Retirement Home)DIAPASONNCT03976661
Measuring the Impact of Taking Care in the Context of an Innovative System for Keeping Dependent Elderly People in Their Homes
An observational study of Patient With no Severe Behavioural Disorders and Whose Situation Would Require Entry Into Classique EHPAD (Retirement Home), run by Gérond'if at 1 site in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Patient With no Severe Behavioural Disorders and Whose Situation Would Require Entry Into Classique EHPAD (Retirement Home)
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2019to 20 Dec 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
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.
Trial locations and contacts
1 site in 1 country.
France1 site
Geriatric department , Broca Hospital
Paris, Île-de-France Region, 75013
About this study
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)
Read the 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)
- Keywords
- No severe behavioural disorders, EHPAD (retirement home), Older patients, loss of autonomy, Groupe-Iso-Ressources (GIR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) | |
| Control arm | Arm will be constituted by people residing at the EHPAD (retirement home) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of life quality according Nottingham Health Profile (NHP) scale
Difference in 12-month quality of life scores (Nottingham Health Profile) between the 2 groups (Diapason 92 and EHPAD).
Measured: 12 months
Secondary outcomes (8)
Assessment of the level of loss of autonomy of an elderly people according Autonomy, gerontology Iso Resources Group (AGGIR) scale
Measured: 12 months
Assessment of functional status according Lawton Instrumental Activities of Daily Living (IADL) Scale
Measured: 12 months
Assessment of activities of daily living, self-care, and independence according Activities of Daily Living (ADL) Scale
Measured: 12 months
Assessment of comorbidity according Charlson scale
Measured: 12 months
Assessment of cognitive function according Mini-Mental State Examination (MMSE) scale
Measured: 12 months
Assessment of disorders of disruptive behaviour according (NPI-ES) scale
Measured: 12 months
Assessment of geriatric depression according Geriatric Depression Scale (GDS) scale
Measured: 12 months
Measuring of burden of the close caregivers according Popular Caregiver Self-report measure Burden (ZARIT)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start29 Apr 2019
- Primary completion29 Dec 2022
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient With no Severe Behavioural Disorders and Whose Situation Would Require Entry Into Classique EHPAD (Retirement Home)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 86 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Phd Hanon, Principal investigator, Geriatric department, Broca hospital (Paris)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976661
- Sponsor's protocol ID
- 2018-A03183-52
- Acronym
- DIAPASON
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2019
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Impact of Taking Care in the Context of an Innovative System for Keeping Dependent Elderly People in Their Homes
- ClinicalTrials.gov ID
- NCT03976661
- Acronym / sponsor ID
- DIAPASON / 2018-A03183-52
- Keywords
- No severe behavioural disorders, EHPAD (retirement home), Older patients, loss of autonomy, Groupe-Iso-Ressources (GIR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
| Control arm | – | –Arm will be constituted by people residing at the EHPAD (retirement home) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of life quality according Nottingham Health Profile (NHP) scale
Time frame: 12 months
Difference in 12-month quality of life scores (Nottingham Health Profile) between the 2 groups (Diapason 92 and EHPAD).
8 secondary outcomes
Assessment of the level of loss of autonomy of an elderly people according Autonomy, gerontology Iso Resources Group (AGGIR) scale
Time frame: 12 months
Assessment of functional status according Lawton Instrumental Activities of Daily Living (IADL) Scale
Time frame: 12 months
Assessment of activities of daily living, self-care, and independence according Activities of Daily Living (ADL) Scale
Time frame: 12 months
Assessment of comorbidity according Charlson scale
Time frame: 12 months
Assessment of cognitive function according Mini-Mental State Examination (MMSE) scale
Time frame: 12 months
Assessment of disorders of disruptive behaviour according (NPI-ES) scale
Time frame: 12 months
Assessment of geriatric depression according Geriatric Depression Scale (GDS) scale
Time frame: 12 months
Measuring of burden of the close caregivers according Popular Caregiver Self-report measure Burden (ZARIT)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Phd Hanon principal investigator
Geriatric department, Broca hospital (Paris)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient With no Severe Behavioural Disorders and Whose Situation Would Require Entry Into Classique EHPAD (Retirement Home), run by Gérond'if at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of life quality according Nottingham Health Profile (NHP) scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.