DisorientationSECURIDRAPNCT05510401
Evaluation of Safe Use of SECURIDRAP® SELFIA®
A study testing SECURIDRAP® SELFIA® in people with Disorientation and Cognitive Impairment, run by Groupe Mulliez-Flory at 10 sites in France.
Trial summary
Interventional, multicenter, prospective and non-comparative clinical investigation carried out in 9 French establishments in order to assess the safety of the SÉCURIDRAP® SELFIA® bedding by mesasuring all the adverse events likend to its use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorientation, Cognitive Impairment, Behavior Disorders
- What is being tested?
- SECURIDRAP® SELFIA®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 10 sitesFrance
- Study dates
- 18 May 2022to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at least 18 years old
- Patient having a medical prescription for SÉCURIDRAP® SELFIA®
- Patient in phase or state of disorientation
- Patient with nocturnal behavior disordre
- Patient with major cognitive impairment
- Patient at risk of falling into bed
Show all 9Show fewer
- Patient subject to guardianship or curatorship
- Patient beneficiary or affiliated to a social security scheme
- Patient who has given their participation agreement aand informed consent
Who cannot join
- Patient and/or guardianship or curatorship refusing to agree to participate in the clinical investigation
- Patient in psychiatry
- Patient with severe agitation
- Patient who will be agitated once installed in the SÉCURIDRAP® SELFIA®
- Patient with intolerance to the medical device
- Patient able to extract himself from SÉCURIDRAP® SELFIA®
Show all 10Show fewer
- Patient able to unlock the bed rails by himself
- Patient without social coverage or not benefiting from it through a third party
- Patient minor, pregnant woman, persons deprived of their liberty
- Patient who participating or having participated in another clinical investigation, drug or medical device in the 30 days preceding inclusion
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
CMMF de Bailleul
Bailleul
Brigitte Dr TILMONT
Brigitte Dr TILMONT
- Recruiting
EHPAD l'Aquarelle
Bully-les-Mines
Valérie Dr WIEL
Valérie Dr WIEL
- Recruiting
Centre Hospitalier d'Hazebrouck
Hazebrouck
Eddy Dr BAHEU
Eddy Dr BAHEU
- Recruiting
Centre Hospitalier Le Quesnoy
Le Quesnoy
Denis Dr LEFEBVRE
Denis Dr LEFBVRE
- Recruiting
CHU Lille
Lille
Francois Dr PUISIEUX
Francois Dr PUISIEUX
- Recruiting
Ussap- Asm Limoux
Limoux
Brigitte Dr GERS
Brigitte Dr GERS
- Recruiting
CHU Lyon
Lyon
Sabiha Dr AHMINE
Sabiha Dr AHMINE
- Recruiting
CHU Rennes
Rennes
Aline Dr CORVOL
Aline Dr CORVOL
- Recruiting
CHG Roubaix
Roubaix
Pearlide Dr Kizonzolo-de-Bello
Pearlide Dr Kizonzolo-de-Bello
- Recruiting
CSSR La Clauze
Saint-Jean-Delnous
Philippe Dr VEAU
Thierry Dr LECRIQUE
About this study
Official title: Multicenter Clinical Investigation for the Evaluation of Safe Use of SECURIDRAP® SELFIA®
Interventional, multicenter, prospective and non-comparative clinical investigation carried out in 9 French establishments in order to assess the safety of the SÉCURIDRAP® SELFIA® bedding by mesasuring all the adverse events likend to its use.
Following the withdrawal from the market of the first version of the SECURIDRAP® SELFIA®, this clinical investigation is being carried out at the request and on the recommandation of the ASNM in order to assess the safety of the second version of the SECURIDRAP® SELFIA® coating.
Read the detailed description
The proposed study is a prospective, multicenter, interventional and non-comparative research.
This clinical investigation is carried out in real life in accordance with the usual care for all patient with a prescription for SECURIDRAP® SELFIA® and who meet the eligibility criteria, in nursing homes and public and private hospitals based in France.
This interventional clinical investigation with minimal risks and constraints aims to confirm the safety of use of SECURIDRAP® SELFIA® in healthcare establishment.
The patient will be followed for 15 nigths, during witch an independent assessor will ensure that the conditions of use os the SECURIDRAP® SELFIA® sleeping bag are respected.
- Conditions
- Disorientation, Cognitive Impairment, Behavior Disorders
- Being tested
- SECURIDRAP® SELFIA®
- Keywords
- disorientation, nocturnal behavioral disorders, major cognitive impairment
- Medical subject headings
- Confusion, Cognitive Dysfunction, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SECURIDRAP® SELFIA®Other
Use of SECURIDRAP® SELFIA® for 15 night
| Study group | Role | What they receive |
|---|---|---|
| SECURIDRAP® SELFIA® | Other | Use of a SECURIDRAP® SELFIA® restraint system Monitoring with passage of an independent assessor Receives: Other: SECURIDRAP® SELFIA® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of occurrence of adverse events related to the use of SÉCURIDRAP® SELFIA®
quotient of the number of overnight stays or at least one adverse event related to the use of SÉCURIDRAP® SELFIA® appeared, by the number of overnight stays where SÉCURIDRAP® SELFIA® was used
Measured: [15 days]
Secondary outcomes (4)
Rate of occurrence of user errors that could endanger patient safety
These usage errors will be measured during the verification of correct use of the SÉCURIDRAP® SELFIA® by the independent assessor, 2 hours after patient has been installed in the medical device
Measured: [15 days]
Rate of patients remaining bedridden each night for the duration of the sudy
P = [(NNL)/ (NU)] x 100 with:
- NNL : the number of nights , patient has not released
- NU : the number of use; (number of overnight stays)
Measured: [15 days]
Satisfaction rate of healthcare teams using SÉCURIDRAP® SELFIA®, in terms of time savings, weel-being, comfort and respect for the dignity of patient
Time saving for healthcare teams via a graduated scale of 0-10 The weel-being / comfort of the patient via a graduated scale of 0-10 Respect for the dignity of the patient via a graduated scale of 0-10
Measured: [15 days]
The learning curve for using SECURIDRAP® SELFIA® by healthcare team
The curve reflects the time required for nursing expertise in the use of SECURIDRAP.
Measured: [15 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start18 May 2022
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisorientationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- non-comparative clinical investigation
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Mulliez-Flory
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
- Investigators
- François Pr PUISIEUX, Principal investigator, CHU LilleAline Dr CORVOL, Principal investigator, Rennes University HospitalSabine Dr AHMINE, Principal investigator, Hospices Civils de LyonThierry Dr LECRIQUE, Principal investigator, CSSR La ClauzeBrigitte Dr GERS, Principal investigator, USSAP- ASM LIMOUXMarguerite Dr REY, Principal investigator, USSAP- ASM LIMOUXValérie Dr WIEL, Principal investigator, EHPAD l'AquarelleBrigitte Dr TILMONT, Principal investigator, CMMF de Bailleul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510401
- Sponsor's protocol ID
- 2019-A03234-53
- Acronym
- SECURIDRAP
- Status last verified
- Nov 2024
- First submitted
- 7 Mar 2022
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Investigation for the Evaluation of Safe Use of SECURIDRAP® SELFIA®
- ClinicalTrials.gov ID
- NCT05510401
- Acronym / sponsor ID
- SECURIDRAP / 2019-A03234-53
- Conditions
- Disorientation, Cognitive Impairment, Behavior Disorders
- Keywords
- disorientation, nocturnal behavioral disorders, major cognitive impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Groupe Mulliez-FloryIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 18 May 2022 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 22 Aug 2022 (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.
Interventional, multicenter, prospective and non-comparative clinical investigation carried out in 9 French establishments in order to assess the safety of the SÉCURIDRAP® SELFIA® bedding by mesasuring all the adverse events likend to its use.
Following the withdrawal from the market of the first version of the SECURIDRAP® SELFIA®, this clinical investigation is being carried out at the request and on the recommandation of the ASNM in order to assess the safety of the second version of the SECURIDRAP® SELFIA® coating.
Detailed description
The proposed study is a prospective, multicenter, interventional and non-comparative research.
This clinical investigation is carried out in real life in accordance with the usual care for all patient with a prescription for SECURIDRAP® SELFIA® and who meet the eligibility criteria, in nursing homes and public and private hospitals based in France.
This interventional clinical investigation with minimal risks and constraints aims to confirm the safety of use of SECURIDRAP® SELFIA® in healthcare establishment.
The patient will be followed for 15 nigths, during witch an independent assessor will ensure that the conditions of use os the SECURIDRAP® SELFIA® sleeping bag are respected.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- non-comparative clinical investigation
| Arm | Type | Receives |
|---|---|---|
| SECURIDRAP® SELFIA® | Other | Other: SECURIDRAP® SELFIA®Use of a SECURIDRAP® SELFIA® restraint system Monitoring with passage of an independent assessor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient at least 18 years old
- Patient having a medical prescription for SÉCURIDRAP® SELFIA®
- Patient in phase or state of disorientation
- Patient with nocturnal behavior disordre
- Patient with major cognitive impairment
Key exclusion criteria (10 listed)
- Patient and/or guardianship or curatorship refusing to agree to participate in the clinical investigation
- Patient in psychiatry
- Patient with severe agitation
- Patient who will be agitated once installed in the SÉCURIDRAP® SELFIA®
- Patient with intolerance to the medical device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SECURIDRAP® SELFIA®Use of SECURIDRAP® SELFIA® for 15 night | Other | SECURIDRAP® SELFIA® |
Primary outcome
Rate of occurrence of adverse events related to the use of SÉCURIDRAP® SELFIA®
Time frame: [15 days]
quotient of the number of overnight stays or at least one adverse event related to the use of SÉCURIDRAP® SELFIA® appeared, by the number of overnight stays where SÉCURIDRAP® SELFIA® was used
4 secondary outcomes
Rate of occurrence of user errors that could endanger patient safety
Time frame: [15 days]
Rate of patients remaining bedridden each night for the duration of the sudy
Time frame: [15 days]
Satisfaction rate of healthcare teams using SÉCURIDRAP® SELFIA®, in terms of time savings, weel-being, comfort and respect for the dignity of patient
Time frame: [15 days]
The learning curve for using SECURIDRAP® SELFIA® by healthcare team
Time frame: [15 days]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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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.
François Pr PUISIEUX principal investigator
CHU Lille
Aline Dr CORVOL principal investigator
Rennes University Hospital
Sabine Dr AHMINE principal investigator
Hospices Civils de Lyon
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SECURIDRAP® SELFIA® in people with Disorientation and Cognitive Impairment, run by Groupe Mulliez-Flory at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Céline BETOUX (0241637810, c.betoux@mulliez-flory.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of occurrence of adverse events related to the use of SÉCURIDRAP® SELFIA® (time frame: [15 days]). 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 20 Nov 2024.