- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01891773
Improving Pediatric Asthma Care Through Inhaled Steroids in Schools (ISIS)
Improving Pediatric Asthma Care Through Inhaled Steroids in Schools (ISIS)
Asthma is the most common chronic pediatric disease in the United States, and is the most common cause of school absenteeism due to a chronic disease. Socioeconomically disadvantaged minority children receive disproportionately poor asthma care and incur a disproportionate share of asthma-related morbidity. The District of Columbia is particularly severely affected, with a lifetime asthma prevalence rate among children 0-17 years of age in 2010 of 22%, more than double the national average.
One of the major challenges in treating asthma is poor adherence to daily controller medications, particularly inhaled corticosteroids (ICS) which are the cornerstone of the NIH guidelines for asthma management. In an attempt to overcome poor compliance, investigators in Rochester, New York have partnered with primary care providers in their community to arrange for ICS administration at school by school nurses, and this approach yielded significant improvements in several asthma outcomes.
The investigators propose to collaborate in a pilot research project with the overall goal of improving asthma outcomes through reducing barriers to medication adherence. Specifically, the investigators aim to improve adherence to controller medications (inhaled corticosteroids - ICS) among DC children with asthma through the following activities:
- A pilot prospective randomized clinical trial of home vs. school administration of ICS among DC children in grades kindergarten-8 with persistent asthma.
- Qualitative interviews with nurses from DC public and public charter school to identify key barriers to administration of daily controller medications in the school setting
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Current enrollment in one of the grades K-8 at a DC public school (DCPS) or DC public charter school (DCPCS)
- Active public insurance
- Persistent asthma
- An Asthma Action Plan including daily ICS
- Child's primary asthma caregiver present, meaning the person who usually takes care of his/her asthma at home and can answer questions about his/her medical history.
Exclusion Criteria:
- Chronic disease of the cardio-pulmonary system other than asthma
- Non-English speaking parent/guardian
- Currently enrolled in in another asthma study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: School-based therapy
Daily dose of medication to be provided in the school setting.
|
Morning dose of inhaled steroids given in school by school nurse instead of at home.
|
간섭 없음: Usual Care
Daily medication to be taken at home.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Proportion of doses received
기간: 60 day treatment period
|
Proportion of doses of ICS received during the 60 days outcome period
|
60 day treatment period
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Stephen Teach, MD, MPH, Children's National Research Institute
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
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. .