Clinical trial NCT04667325: Evaluation of Therapeutic Adherence to Inciting Spirometry in Sickle Cell Patients
Official title: Evaluation de l'Observance thérapeutique à la spirométrie Incitative Chez Les Patients drépanocytaires
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Keywords: acute chest syndrome, incentive spirometry, compliance
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with sickle cell anemia

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. (3,4) 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. (3.4) 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.


Eligibility criteria: Inclusion Criteria:

* Patients with sickle cell disease,
* Major
* No opposition for participation in the protocol

Exclusion Criteria:

* Patients unable to answer the questionnaire due to linguistic or other problems
* Patients under guardianship or curatorship

Primary outcomes:
measure: To take stock of the observance of sickle cell patients with inciting spirometry
timeFrame: Through study completion, an everage of 10 minutes
Secondary outcomes:
measure: To take stock of patients' knowledge of their pathology and incentive spirometry
timeFrame: Through study completion, an everage of 10 minutes
measure: Measuring adherence to medical follow-up
timeFrame: Through study completion, an everage of 10 minutes
measure: Assessing the impact of the disease on quality of life
timeFrame: Through study completion, an everage of 10 minutes
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre hospitalier intercommunal de Créteil
Study officials:
References: