Ignite Creation Date:
2024-05-06 @ 6:22 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05649280
Status:
COMPLETED
Last Update Posted:
2022-12-14
First Post:
2022-06-01
Brief Title:
Safety Evaluation of DREPADOM - Home Care Services and Hospitalizations for Sickle Cell Disease Patients
Sponsor:
Soutien aux Actions contre les Maladies du Globule Rouge
Organization:
Soutien aux Actions contre les Maladies du Globule Rouge
Study Overview
Official Title:
Safety Evaluation of DREPADOM - Home Care Services and Hospitalizations for Sickle Cell Disease Patients
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DREPADOM
Brief Summary:
The objective of this study is to evaluate the incidence of ACS within the DREPADOM system and compare it to expected incidences of ACS historic cohorts of PRESEV1 and PRESEV2
Detailed Description:
This prospective observational study will take place as follows
Calculation of the PRESEV score in the ER will determine or not eligibility of the patient in the DREPADOM structure With a low score a patient is eligible for home monitoring and after duly provided information can sign a patient consent for the use of personal medical data
The coordinating nurse from DREPADOM can then set up a whole network with the delivery of oxygen supply at the patients house dispatch of a medical prescription to a neighboring pharmacy and daily visits from homecare service providers Both opioids and parenteral hydration and treatments can be prescribed and daily visits up to three are programmed As such the patient receives a minimum of 1 visit per day from a nurse for monitoring and is provided with a medical oxygen concentrator for home use 3Lmin continuously or for at least 15hday and parenteral hydration In addition patients are called daily by general practitioners or SCD experts for teleconsultations
The DREPADOM coordinating nurse is in constant interaction with nursesproviders of homecare servicesmedical doctors and status and evolution of the patients global condition is reported both through the constant contact with the coordinating nurse from DREPADOM and in a dedicated software Link4Life with monitoring of blood pressure temperature respiratory rate pain etc Link4Life is a software tool developed especially for home monitoring It is adaptable to specific disorders fully complies with the French Law for Health Data management and allows data extraction Link4Life has been adapted to SCD in full collaboration with SCD medical experts of the Henri Mondor hospital It is to be noted that all medical doctors general practitioners or SCD experts as well as coordinating and visiting nurses have all access to this application As such Link4Life will gather and capture all patient data
When reporting patients clinical parameters daily in the dedicated app controlled by the DREPADOM team of experts alerts are generated in the software when these are above or below determined thresholds The medical team of experts from DREPADOM then takes over for daily teleconsultations and medical decisions for pursuing home monitoring or hospital admittance
Of important note a patient can be included twice in the DREPADOM study for two distinct VOCs Indeed the PRESEV1 study highlighted that each crisis is unique and should be treated accordingly
Data capture will be done through the Link4Life software as well as extraction for data analysis
Open-label
Blind
Number of treatment arms
Single arm
Multi arms specify the number of arms
Not Controlled
Controlled specify the comparator
Versus placebo Versus reference product Versus other specify -Randomized Parallel group Cross over Other specify
-Intervention gas andor drug andor device andor service study arm
Calculation of the PRESEV score in the ER will determine or not eligibility of the patient in the DREPADOM structure With a low score a patient is eligible for home monitoring and after duly provided information can sign a patient consent for the use of personal medical data
The coordinating nurse from DREPADOM can then set up a whole network with the delivery of oxygen supply at the patients house dispatch of a medical prescription to a neighboring pharmacy and daily visits from homecare service providers Both opioids and parenteral hydration and treatments can be prescribed and daily visits up to three are programmed As such the patient receives a minimum of 1 visit per day from a nurse for monitoring and is provided with a medical oxygen concentrator for home use 3Lmin continuously or for at least 15hday and parenteral hydration In addition patients are called daily by general practitioners or SCD experts for teleconsultations
The DREPADOM coordinating nurse is in constant interaction with nursesproviders of homecare servicesmedical doctors and status and evolution of the patients global condition is reported both through the constant contact with the coordinating nurse from DREPADOM and in a dedicated software Link4Life with monitoring of blood pressure temperature respiratory rate pain etc Link4Life is a software tool developed especially for home monitoring It is adaptable to specific disorders fully complies with the French Law for Health Data management and allows data extraction Link4Life has been adapted to SCD in full collaboration with SCD medical experts of the Henri Mondor hospital It is to be noted that all medical doctors general practitioners or SCD experts as well as coordinating and visiting nurses have all access to this application As such Link4Life will gather and capture all patient data
When reporting patients clinical parameters daily in the dedicated app controlled by the DREPADOM team of experts alerts are generated in the software when these are above or below determined thresholds The medical team of experts from DREPADOM then takes over for daily teleconsultations and medical decisions for pursuing home monitoring or hospital admittance
Of important note a patient can be included twice in the DREPADOM study for two distinct VOCs Indeed the PRESEV1 study highlighted that each crisis is unique and should be treated accordingly
Data capture will be done through the Link4Life software as well as extraction for data analysis
Open-label
Blind
Number of treatment arms
Single arm
Multi arms specify the number of arms
Not Controlled
Controlled specify the comparator
Versus placebo Versus reference product Versus other specify -Randomized Parallel group Cross over Other specify
-Intervention gas andor drug andor device andor service study arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None