- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04667325
Evaluation of Therapeutic Adherence to Inciting Spirometry in Sickle Cell Patients
Evaluation de l'Observance thérapeutique à la spirométrie Incitative Chez Les Patients drépanocytaires
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.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Créteil, 프랑스, 94000
- Centre Hospitalier Intercommunal de Créteil
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
To take stock of the observance of sickle cell patients with inciting spirometry
기간: Through study completion, an everage of 10 minutes
|
Measuring compliance through the questionnaire
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Through study completion, an everage of 10 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
To take stock of patients' knowledge of their pathology and incentive spirometry
기간: Through study completion, an everage of 10 minutes
|
Assessing knowledge about their pathology and treatment via the questionnaire
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Through study completion, an everage of 10 minutes
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Measuring adherence to medical follow-up
기간: Through study completion, an everage of 10 minutes
|
Measuring the number of consultations via the questionnaire
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Through study completion, an everage of 10 minutes
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Assessing the impact of the disease on quality of life
기간: Through study completion, an everage of 10 minutes
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Measuring the patient's quality of life via the questionnaire
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Through study completion, an everage of 10 minutes
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- KINEDREP
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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