Evaluation of Therapeutic Adherence to Inciting Spirometry in Sickle Cell Patients

NCT04667325 | Completed

• 1 other identifier: KINEDREP
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

acute chest syndrome, incentive spirometry, compliance

Outcome Measures

Primary Outcomes (1)

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

  Measuring compliance through the questionnaire

  Through study completion, an everage of 10 minutes

Secondary Outcomes (3)

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

  Through study completion, an everage of 10 minutes

• Measuring adherence to medical follow-up

  Through study completion, an everage of 10 minutes

• Assessing the impact of the disease on quality of life

  Through study completion, an everage of 10 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with sickle cell anemia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

Centre hospitalier intercommunal de Créteil

Créteil, 94000, France

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Acute Chest Syndrome; Patient Compliance

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 14, 2020
• Study Start: January 1, 2021
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

FR (1)