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Impact of a Curriculum Intervention on Asthma Knowledge in Adolescents of a Public School in Salvador-Bahia-Brazil (KARE)

6 lipca 2016 zaktualizowane przez: Ana Carla Carvalho Coelho, Federal University of Bahia
The purpose of this study is to estimate the impact of a curriculum intervention on asthma knowledge in adolescents of a public school in Salvador-Bahia-Brazil.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

Asthma is one of major causes of morbidity and mortality due to chronic diseases worldwide with higher mortality and morbidity in adolescents. Interventions directed to adolescents and systematically developed within the school environment has been performed around the world. In spite of that, studies such Bruzzese (2004; 2011) have already shown that clinical interventions associated with educational activities in group composed of individuals with similar lifestyles and characteristics are able to modify the behavior of the individual as well as reduce emergency room visits and hospitalizations. Thus, it is necessary to develop this study.

This study is a controlled clinical trial. The intervention will be a curriculum intervention on asthma. This intervention will consist of theoretical - practical weekly workshops with a targeted content for asthma and involves aspects related to anatomy and physiology of the respiratory tract, conceptualization of asthma, prevention, treatment, maintenance and retrieval; recognition and actions in periods of exacerbations and use the action plan. These workshops are suitable for the course plan of disciplines sciences, biology, chemistry, physics, history , geography, portuguese and mathematics . Those are characterized as a mandatory curriculum component and they should be developed for all students in elementary and secondary education.

In parallel curriculum intervention, the investigators will identify the frequency of individuals with diagnosis/symptoms suggestive of asthma by applying the ISAAC questionnaire and verification of Forced Expiratory Volume in one second (FEV1) using the portable Vitalograph copd - 6. This assessment will identify students with suspected asthma, symptoms suggestive of asthma and asthma diagnosed.

The curriculum will be organized educational intervention with school staff to be applied to the intervention group (it includes all students from 10 to 19 years previously registered. The afternoon shift is defined as the intervention group and may participate asthmatic and non-asthmatic students). It is noteworthy that, subsequently, the same intervention will be performed with the control group (in which students participate in the morning shift and may participate in asthmatic and non-asthmatic students). The intervention group will receive a complementary intervention where questions directed reinforce attitudes in periods of exacerbation and use the action plan, while the control group will receive this same intervention after the study.

The study will be held at the College Presidente Emilio Garrastazu Medici (Currently its name is College Estadual do Stiep Carlos Marighella) which is a school unit with medium-sized and offers all series of the second segment of the Elementary School, Middle School and Professional Education. This school was chosen because of system of evaluation and teaching methodology as well defined in its political pedagogical project.

The investigators will identify the frequency of individuals with diagnosis/symptoms suggestive of asthma by applying the ISAAC questionnaire and verification of Forced Expiratory Volume in one second (FEV1) will monitor all individuals duly registered and allocated in the age group 10-19 years are enrolled in the 5th to 8th grades in this study.

A despite about data Collection Instrument, will be used: 1. Questionnaires ISAAC - International Study of Asthma and Allergies in Childhood; 2. Form to characterize the subjects and clinical outcomes and 3. Structured questionnaires for assessing knowledge (two different data collection instruments):

  1. Questionnaires ISAAC - International Study of Asthma and Allergies in Childhood:

    In the first phase of the study, standardized questionnaires developed by ISAAC will be applied. It aims to evaluate symptoms suggestive of asthma. The first part of the questionnaire consists of 8 questions which mainly use 3 questions to estimate the prevalence of asthma : 1 - " Did you ever in your life you (or your child ) had wheezing (wheezing )? " , 2 - "In the last twelve months you (or your child ) had wheezing ( wheezing )?" 3 - "Have you ( or your child ) had asthma?".

  2. Form to characterize the subjects and clinical outcomes:

    This form is composed of two parts: the first part consists of demographic and socio biological data and the second parts of issues related to clinical outcomes. The variables are emergency due to asthma in the past year, emergency due to asthma in past 30 days, emergency due to asthma past two weeks, prior oral intubation, hospitalization due to asthma in the last year, ICU admissions, nocturnal awakenings in the last year, nocturnal awakenings in the last 30 days, nighttime awakenings in the last two weeks, daytime last year awakenings, daytime awakenings in the last 30 days, daytime awakenings in the last two weeks, number of days missed at school in the last year, number of days missed at school last month, number of lost subjects (if already deprecated) in the last year, use of control medications, spirometric values. This form must be applied before and after implementation of the intervention.

  3. Form for assessing knowledge:

To assess knowledge about asthma and the exacerbation due to this disease, a structured questionnaire that contains 20 questions with three possible answers to all questions will be used: "Yes", "no" and " I do not know". This questionnaire is organized so that a number of questions covering a field but it is not built for the explicit subject in the research.

The areas are: knowledge of the pathology, triggers, treatment, management of crisis and myths/truths so that the researcher can analyze the performance counting the overall score and domains.The adjustments represent the knowledge level of the respondent. Up to 25 % of hits - Poor knowledge; 26 - 50% correct - satisfactory knowledge; 51-75 % accuracy - Good knowledge; 76-100 % correct - excellent knowledge.

Knowledge about learning about relief treatment and maintenance will be carried out through a questionnaire consists of 4 situations that mimic reality. It trys to observe the therapeutic knowledge of the individual in situations of imminent asthma attack , with the following options answer: "never", "rarely", "sometimes" , "often" ,"always".

The investigators will collect data and analyzed in the period from October 2011 to December 2014. Tools of data collection described above and after signing the Informed Consent and the Coordinator of School and after approval of the research by the Ethics Committee - Universidade Federal da Bahia. This protocol was submitted and approved.

The investigators will use the Statistical Programme Statistic Program for Social Sciences (SPSS) version 21.0 to process data. We will analyse data by descriptive statistics (proportions and measures of central tendency), Relative risk (RR) , absolute risk (AR) , odds ratios (OR) and logistic regression analysis to identify the measures of association will be used effect of systematic educational interventions independent of confounding variables. In all analyzes will be considered the significance level of 5 % .

The ethical aspects shall be based on Resolution 196/96 governing research involving human subjects, the resolution 466/2012 and the Code of Ethics for Professional Nursing. The research will respect the basic principles of bioethics: autonomy, non - maleficence, beneficence, and justice, and should be appropriate to scientific principles, rely on free and informed consent of the research subject and / or his legal representative, establish procedures to ensure confidentiality and privacy of the people involved indirectly. The Program will receive the return of the results obtained through research.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

181

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Bahia
      • Salvador, Bahia, Brazylia
        • Universidade Federal da Bahia and College Estadual Presidente Emílio Garrastazu Médici (Currently its name is College Estadual do Stiep Carlos Marighella)

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

10 lat do 19 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • All students aged 10-19 years enrolled in the College Presidente Emilio Garrastazu Medici (Currently its name is College Estadual do Stiep Carlos Marighella) whose present the Statement of Consent Form signed by parents/ tutors and by themselves;
  • Individuals of the same age with symptoms suggestive of asthma and/or previous diagnosis as well as those without asthma after signing the Statement of Consent Form may be included;

Exclusion Criteria:

  • Individuals not willing to participate of the study;
  • Individuals who have not signed the consent form;
  • Individuals with cognitive impairment and with any special needs must not be included in this study.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: KARE Intervention
KARE - Knowledge about Asthma and Respiratory Education is an educational curriculum intervention organized with school staff to be applied to the intervention group. This intervention will consist of theoretical - practical weekly workshops with a targeted content for asthma and involves aspects related to anatomy and physiology of the respiratory tract, conceptualization of asthma, prevention, treatment, maintenance and retrieval; recognition and actions in periods of exacerbations and use the action plan. These workshops are suitable for the course plan of disciplines sciences, biology, chemistry, physics, history, geography, portuguese and mathematics. Those are characterized as a mandatory curriculum component and they should be developed for all students.
KARE - Knowledge about Asthma and Respiratory Education is an educational curriculum intervention organized with school staff to be applied to the intervention group. This intervention will consist of theoretical - practical weekly workshops with a targeted content for asthma and involves aspects related to anatomy and physiology of the respiratory tract, conceptualization of asthma, prevention, treatment, maintenance and retrieval; recognition and actions in periods of exacerbations and use the action plan. These workshops are suitable for the course plan of disciplines sciences, biology, chemistry, physics, history, geography, portuguese and mathematics. Those are characterized as a mandatory curriculum component and they should be developed for all students.
Brak interwencji: A traditional curriculum education.
The control group will receive a traditional curriculum education.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Change from baseline Knowledge about asthma in adolescents of a public school in Salvador-Bahia- Brazil at 3 months
Ramy czasowe: Baseline; up to 2 weeks; up to 3 months; up to 1 year after intervention
Baseline; up to 2 weeks; up to 3 months; up to 1 year after intervention

Miary wyników drugorzędnych

Miara wyniku
Ramy czasowe
Visits to emergency in the subgroup of patients with asthma/ symptoms suggestive of asthma
Ramy czasowe: Baseline; up to 2 weeks and up to 3 months
Baseline; up to 2 weeks and up to 3 months
Hospitalization in the subgroup of patients with asthma/ symptoms suggestive of asthma.
Ramy czasowe: Baseline; up to 2 weeks and up to 3 months
Baseline; up to 2 weeks and up to 3 months
Daytime and nighttime awakenings in the subgroup of patients with asthma/ symptoms suggestive of asthma
Ramy czasowe: Baseline; up to 2 weeks and up to 3 months
Baseline; up to 2 weeks and up to 3 months
Rescue medication use in the subgroup of patients with asthma/ symptoms suggestive of asthma
Ramy czasowe: Baseline; up to 2 weeks and up to 3 months
Baseline; up to 2 weeks and up to 3 months
Use of the action plan in the subgroup of patients with asthma/ symptoms suggestive of asthma
Ramy czasowe: Baseline; up to 2 weeks and up to 3 months
Baseline; up to 2 weeks and up to 3 months
Absenteeism to school in the subgroup of patients with asthma/ symptoms suggestive of asthma
Ramy czasowe: Baseline; up to 2 weeks and up 3 months
Baseline; up to 2 weeks and up 3 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Dyrektor Studium: Adelmir Souza-Machado, PHD, Federal University of Bahia

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 listopada 2012

Zakończenie podstawowe (Rzeczywisty)

1 października 2014

Ukończenie studiów (Rzeczywisty)

1 grudnia 2014

Daty rejestracji na studia

Pierwszy przesłany

11 maja 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 maja 2014

Pierwszy wysłany (Oszacować)

20 maja 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

7 lipca 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 lipca 2016

Ostatnia weryfikacja

1 lipca 2016

Więcej informacji

Terminy związane z tym badaniem

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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