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Completed

NCT Number: NCT04667325

Evaluation of Therapeutic Adherence to Inciting Spirometry in Sickle Cell Patients

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To take stock of the observance of sickle cell patients with inciting spirometry

    Time frame: Through study completion, an everage of 10 minutes

    Measuring compliance through the questionnaire

Secondary outcomes

  1. To take stock of patients' knowledge of their pathology and incentive spirometry

    Time frame: Through study completion, an everage of 10 minutes

    Assessing knowledge about their pathology and treatment via the questionnaire

  2. Measuring adherence to medical follow-up

    Time frame: Through study completion, an everage of 10 minutes

    Measuring the number of consultations via the questionnaire

  3. Assessing the impact of the disease on quality of life

    Time frame: Through study completion, an everage of 10 minutes

    Measuring the patient's quality of life via the questionnaire

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study title

Evaluation de l'Observance thérapeutique à la spirométrie Incitative Chez Les Patients drépanocytaires

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 14, 2020
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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