Viewing Study NCT04667325



Ignite Creation Date: 2024-05-06 @ 3:32 PM
Last Modification Date: 2024-10-26 @ 1:51 PM
Study NCT ID: NCT04667325
Status: COMPLETED
Last Update Posted: 2021-02-23
First Post: 2020-11-30

Brief Title: Evaluation of Therapeutic Adherence to Inciting Spirometry in Sickle Cell Patients
Sponsor: Centre Hospitalier Intercommunal Creteil
Organization: Centre Hospitalier Intercommunal Creteil

Study Overview

Official Title: Evaluation de lObservance thérapeutique à la spirométrie Incitative Chez Les Patients drépanocytaires
Status: COMPLETED
Status Verified Date: 2021-02
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: None
Brief Summary: Sickle cell disease is one of the most common genetic diseases in the world 1 It is characterized by the production of abnormal hemoglobin mainly responsible for vaso-occlusive clinical manifestations and chronic hemolysis with anemia 2 It is therefore a chronic disease with major acute complications such as acute chest syndrome The treatment for this syndrome will be based on oxygenation hydration and analgesia At the physiotherapy level we will have an action on the prevention and treatment of the syndrome by incentive spirometry 34 In fact it is currently the only physiotherapy treatment that has proven its effectiveness and is recommended for sickle cell patients 3 As part of prevention it is recommended to prescribe incentive spirometry during vaso-occlusive crisis It has been shown to reduce the risk of atelectasis and significantly limit the risk of developing ACS 5 In treatment it makes it possible to regain normal chest amplification and therefore to allow ventilation of unventilated areas 34 However in order to increase therapeutic efficacy patient compliance is essential

Adherence to treatment is a major problem in chronic diseases Currently it is estimated that 80 of patients with chronic conditions do not sufficiently follow their therapy which limits the optimization of benefits 6 This is the case in sickle cell patients especially with hydroxyurea which is their disease-modifying treatment Lack of adherence is the most common cause of primary failure of this treatment

During various treatments we noticed the patients lack of compliance with spirometry Indeed we explained to the patient how to do the incentive spirometry so that he could practice it several times a day as recommended When we returned the next day or after a weekend most of the time the patients had little or no observance So I wanted to know if this concerns a majority of patients with sickle cell disease Indeed it appears important to assess compliance in these patients in order to improve the effectiveness of treatment and reduce the risk of ACS
Detailed Description: None

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