- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01979224
Efficacy of Educational Intervention for Parents of Children With Asthma
2013년 10월 31일 업데이트: Blanca Nohemí Zamora Mendoza, Universidad Autonoma de San Luis Potosí
Efficacy of Educational Intervention for Parents of Children With Asthma in 4-11 Years and Their Impact on the Control Children as Measured by ACT. Randomized Controlled Clinical
Introduction.
Asthma is a chronic inflammatory disorder of the airways, identified by airflow obstruction.
Unfortunately only 2.4% of American asthmatics meet internationally recommended criteria for control.
The lack of knowledge in parents of asthmatic children has been a direct result of minimum or no control at all, so the educational programs need to be assessed in terms of improvement of the control.
Target.
To determine whether an educational intervention aimed at parents of asthmatic children 4 to 11 years improved clinical control measured by Test Childhood Asthma Control.
Material and Methods.
Randomized controlled clinical trial in 42 patients randomly divided into two groups that were evaluated in the same time knowledge and control of asthma, a measurement was performed at baseline and monthly for nine months.
The experimental group attended an educational intervention for individual reinforcements through this period, the control group was only monitored
연구 개요
상세 설명
- Recruitment of patients that attended hospital's emergency gate due to asthma issues, and phone calls to regular physicians patients.
- Once recruited all parents of patients were asked to participate in the study where their children will be evaluated on an asthma control and asked informed consent
- The clinical history, spirometry and / or basal peak flow Diagnostic concordance
- With the collected data was performed a database clinical history, ACT score, FEV1 and PEF, results of each patient and personal data for future location, the base was used for the concordance of diagnosis.
- Once the sample that met the selection criteria were formed experimental and control groups at random using "R Project Statistical Computing" 2.12.2 version performed by the statistical
- The experimental group was invited to participate in educational sessions two hours at week in just one month and monthly individual reinforcements through the evaluation period.
- Educational sessions were based on the Global Initiative for Asthma (GINA), Guía Española para el Manejo del Asma (GEMA) And Concenso Mexicano de Asma.
- Those measurements were performed by an external partner or educators or the attending physician performed to avoid biased results.
The monthly ACT and peak flow of the attending physician were blinded
variables:
- educational intervention, with and without intervention
- asthma control: measured by infant ACT
- time: 0 to 9 months
- sex: female or male
- Age: 4 to 11 years
연구 유형
중재적
등록 (실제)
42
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
4년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Eligibility Criteria
- Children 4-11 years with diagnosed asthma with parents attending the outpatient pediatric pneumology and pediatric emergency because of acute asthma in General Hospital de Soledad.
- Patients with a baseline score less than 27 points in childhood ACT
- Patients with Government Health Insurance. (to ensure access to medication and medical care)
- Parents who can read and write
- Parents willing and able to participate
- Parents who do not belong or have been part of an educational program on asthma by asthma clinic.
Exclusion Criteria
- Parents with children having other comorbidities that prevent or hinder proper control of asthma, such as Cerebral Palsy, (PCI) psychomotor retardation, psychiatric Sd. Down, congenital malformations, which alter the chest wall, obesity, nasal polyp.
Elimination criteria
- Parents who fail to attend 50% of the sessions given (since it does not allow parents to acquire sufficient knowledge to significantly improve the control of asthma as GEMA educational guidance)
- Patients and parents who decide not to continue in the project.
- Patients who develop pulmonary comorbidities over a month of evolution and lung tissue affecting significantly, as syncytial respiratory virus, pneumonia, tuberculosis, and asthma control difficulties.
- Patients who leave or do not take the prescribed treatment by physician for a month.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: treatment and routine counseling
Parents attend regular consultation and receive regular medical guidance
|
educational sessions once a week two hours for a month and later educational reinforcement and monitoring asthma control monthly for nine months
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
asthma control
기간: 9 months
|
9 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Blanca ZM master, Universidad Autónoma de San Luis Potosí México
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 2월 1일
기본 완료 (실제)
2012년 10월 1일
연구 완료 (실제)
2013년 10월 1일
연구 등록 날짜
최초 제출
2013년 5월 30일
QC 기준을 충족하는 최초 제출
2013년 10월 31일
처음 게시됨 (추정)
2013년 11월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2013년 11월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 10월 31일
마지막으로 확인됨
2013년 10월 1일
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. .
Educational intervention for parents에 대한 임상 시험
-
Uppsala UniversityUniversity of Konstanz; Bielefeld University; Dar es Salaam University College of Education; University of North Carolina, Charlotte아직 모집하지 않음
-
Northeastern UniversitySociety for Pediatric Psychology; APA: American Psychological Association모병
-
University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)아직 모집하지 않음