- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01282359
Efficacy of a Minimal Intervention Educational Program in the Asthma Control and Exacerbations Prevention (PROMETEO)
The asthma clinical practice guidelines categorize with the highest evidence level the effectiveness of educational programs. However, health care professionals not regularly applied it. This may contribute to inadequate control of the disease. Consequently, their designs and implementation strategies should be reviewed.
Hypothesis. An asthma educational program based on a limited intervention, managed by professionals with minimal training in education, could provide a significant decrease in the morbidity of the disease.
Objective. Determine the effectiveness, in terms of prevention of exacerbations (future risk) and improved asthma control (current control) of an educational program based on a reduced or minimal intervention.
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Barcelona, 스페인, 08025
- Hospital de la Santa Creu i Sant Pau
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male and female asthma patients with mild or moderate persistent asthma after treatment according to criteria of the GINA2009.
- Aged 18 and under 70 years.
- With ACT (Asthma Control Test) <20 treated at the outpatient clinics of the participating centers.
Exclusion Criteria:
- Severe exacerbation of asthma (which required emergency room visit and/or hospitalization) within 30 days prior to visit 1.
- Severe disabling comorbidity.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Clinical Practice Group
Patients collected in centres randomized as usual clinical practice, who will not receive the limited educational asthma program.
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Clinical practice group will not receive any specific education
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다른: "Gold Standard" educational group
Patients will receive a formal program of structured and individualized education, enrolled in centres recognized by using high standard procedures in asthma education.
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"Gold Standard" educational group will receive a formal program of structured and individualized education
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다른: Intervention group
This group will receive a limited educational asthma program (minimal educational intervention)
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Intervention group will take the limited educational asthma program which have three parts: basic information, establishment and revision of a small Action Plan (MiniPlan) and training and review of the inhalation skill of the prescribed device.
Educators involved will attend a short workshop (6 h), where they will be trained in the program.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of asthma exacerbations
기간: 1 year
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Patients will be followed for a year in four programmed visits.
At baseline and at follow-up visits, will be collected in each patient the number of asthma exacerbations.
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1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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ACT score
기간: 1 year
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Patients will be followed for a year in four programmed visits.
At baseline and at follow-up visits, will be collected in each patient the Asthma Control Test score.
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1 year
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공동 작업자 및 조사자
수사관
- 연구 의자: Antolin Lopez, MD, Hospital Universitario Puerta Hierro Madrid (Spain)
- 연구 의자: Meritxell Peiro, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- 연구 의자: José M Ignacio, MD, Hospital Serrania de Ronda. Málaga (Spain).
- 연구 의자: José A Quintano, MD, Centro de Salud Lucena I. Lucena. Córdoba (Spain).
- 연구 의자: Santiago Bardagí, MD, Hospital de Mataró. Barcelona (Spain)
- 수석 연구원: Vicente Plaza, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
간행물 및 유용한 링크
일반 간행물
- Morell F, Genover T, Reyes L, Benaque E, Roger A, Ferrer J. [Monitoring of asthma outpatients after adapting treatment to meet international guidelines]. Arch Bronconeumol. 2007 Jan;43(1):29-35. doi: 10.1016/s1579-2129(07)60017-2. Spanish.
- Mansour ME, Rose B, Toole K, Luzader CP, Atherton HD. Pursuing perfection: an asthma quality improvement initiative in school-based health centers with community partners. Public Health Rep. 2008 Nov-Dec;123(6):717-30. doi: 10.1177/003335490812300608.
- Henry RL, Gibson PG, Vimpani GV, Francis JL, Hazell J. Randomized controlled trial of a teacher-led asthma education program. Pediatr Pulmonol. 2004 Dec;38(6):434-42. doi: 10.1002/ppul.20095.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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