Evaluation of Safe Use of SECURIDRAP® SELFIA® (SECURIDRAP)
Primary Purpose
Disorientation, Cognitive Impairment, Behavior Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SECURIDRAP® SELFIA®
Sponsored by
About this trial
This is an interventional other trial for Disorientation focused on measuring disorientation, nocturnal behavioral disorders, major cognitive impairment
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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®
- 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
Sites / Locations
- François PUISIEUXRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SECURIDRAP® SELFIA®
Arm Description
Use of a SECURIDRAP® SELFIA® restraint system Monitoring with passage of an independent assessor
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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)
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
The learning curve for using SECURIDRAP® SELFIA® by healthcare team
The curve reflects the time required for nursing expertise in the use of SECURIDRAP.
Full Information
NCT ID
NCT05510401
First Posted
March 7, 2022
Last Updated
August 18, 2022
Sponsor
Groupe Mulliez-Flory
Collaborators
EVAMED
1. Study Identification
Unique Protocol Identification Number
NCT05510401
Brief Title
Evaluation of Safe Use of SECURIDRAP® SELFIA®
Acronym
SECURIDRAP
Official Title
Multicenter Clinical Investigation for the Evaluation of Safe Use of SECURIDRAP® SELFIA®
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Mulliez-Flory
Collaborators
EVAMED
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorientation, Cognitive Impairment, Behavior Disorders
Keywords
disorientation, nocturnal behavioral disorders, major cognitive impairment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
non-comparative clinical investigation
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SECURIDRAP® SELFIA®
Arm Type
Other
Arm Description
Use of a SECURIDRAP® SELFIA® restraint system Monitoring with passage of an independent assessor
Intervention Type
Other
Intervention Name(s)
SECURIDRAP® SELFIA®
Intervention Description
Use of SECURIDRAP® SELFIA® for 15 night
Primary Outcome Measure Information:
Title
Rate of occurrence of adverse events related to the use of SÉCURIDRAP® SELFIA®
Description
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
Time Frame
[15 days]
Secondary Outcome Measure Information:
Title
Rate of occurrence of user errors that could endanger patient safety
Description
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
Time Frame
[15 days]
Title
Rate of patients remaining bedridden each night for the duration of the sudy
Description
P = [(NNL)/ (NU)] x 100 with:
NNL : the number of nights , patient has not released
NU : the number of use; (number of overnight stays)
Time Frame
[15 days]
Title
Satisfaction rate of healthcare teams using SÉCURIDRAP® SELFIA®, in terms of time savings, weel-being, comfort and respect for the dignity of patient
Description
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
Time Frame
[15 days]
Title
The learning curve for using SECURIDRAP® SELFIA® by healthcare team
Description
The curve reflects the time required for nursing expertise in the use of SECURIDRAP.
Time Frame
[15 days]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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®
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Céline BETOUX
Phone
0241637810
Email
c.betoux@mulliez-flory.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Babette MAKPANGOU
Phone
0231932118
Email
babette.makpangou@evamed.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Pr PUISIEUX
Organizational Affiliation
CHU Lille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aline Dr CORVOL
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sabine Dr AHMINE
Organizational Affiliation
CHU LYON
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thierry Dr LECRIQUE
Organizational Affiliation
CSSR La Clauze
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brigitte Dr GERS
Organizational Affiliation
USSAP- ASM LIMOUX
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marguerite Dr REY
Organizational Affiliation
USSAP- ASM LIMOUX
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valérie Dr WIEL
Organizational Affiliation
EHPAD l'Aquarelle
Official's Role
Principal Investigator
Facility Information:
Facility Name
François PUISIEUX
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Babette MAKPANGOU
Phone
0033 231932118
Email
babette.makpangou@evamed.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Safe Use of SECURIDRAP® SELFIA®
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