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AsthmaKARENCT02142179

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

A study testing Knowledge about Asthma and Respiratory Education (KARE) in people with Asthma, run by Federal University of Bahia at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 10 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
What is being tested?
Knowledge about Asthma and Respiratory Education (KARE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
1 siteBrazil
Study dates
Nov 2012to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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;

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Universidade Federal da Bahia and College Estadual Presidente Emílio Garrastazu Médici (Currently its name is College Estadual do Stiep Carlos Marighella)

    Salvador, Estado de Bahia

Other trials in Brazil

About this study

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.

Read the detailed description

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.

Conditions
Asthma
Being tested
Knowledge about Asthma and Respiratory Education (KARE)
Keywords
Asthma, Knowledge, School-Based Service, Adolescents
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Knowledge about Asthma and Respiratory Education (KARE)Behavioural

    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.

Study groups in NCT02142179
Study groupRoleWhat they receive
KARE InterventionExperimentalKARE - 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.
Receives: Behavioral: Knowledge about Asthma and Respiratory Education (KARE)
A traditional curriculum education.No interventionThe control group will receive a traditional curriculum education.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline Knowledge about asthma in adolescents of a public school in Salvador-Bahia- Brazil at 3 months

    Measured: Baseline; up to 2 weeks; up to 3 months; up to 1 year after intervention

Secondary outcomes (6)
  1. Visits to emergency in the subgroup of patients with asthma/ symptoms suggestive of asthma

    Measured: Baseline; up to 2 weeks and up to 3 months

  2. Hospitalization in the subgroup of patients with asthma/ symptoms suggestive of asthma.

    Measured: Baseline; up to 2 weeks and up to 3 months

  3. Daytime and nighttime awakenings in the subgroup of patients with asthma/ symptoms suggestive of asthma

    Measured: Baseline; up to 2 weeks and up to 3 months

  4. Rescue medication use in the subgroup of patients with asthma/ symptoms suggestive of asthma

    Measured: Baseline; up to 2 weeks and up to 3 months

  5. Use of the action plan in the subgroup of patients with asthma/ symptoms suggestive of asthma

    Measured: Baseline; up to 2 weeks and up to 3 months

  6. Absenteeism to school in the subgroup of patients with asthma/ symptoms suggestive of asthma

    Measured: Baseline; up to 2 weeks and up 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2014 (estimated)
  2. Study startNov 2012
  3. Primary completionOct 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02142179
Sponsor's protocol ID
KARE-001
Acronym
KARE
Status last verified
Jul 2016
First submitted
11 May 2014
Last updated
7 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Bruzzese JM, Sheares BJ, Vincent EJ, Du Y, Sadeghi H, Levison MJ, Mellins RB, Evans D. Effects of a school-based intervention for urban adolescents with asthma. A controlled trial. Am J Respir Crit Care Med. 2011 Apr 15;183(8):998-1006. doi: 10.1164/rccm.201003-0429OC. Epub 2010 Dec 7.

    PubMed 21139088
  • Sole D, Wandalsen GF, Camelo-Nunes IC, Naspitz CK; ISAAC - Brazilian Group. Prevalence of symptoms of asthma, rhinitis, and atopic eczema among Brazilian children and adolescents identified by the International Study of Asthma and Allergies in Childhood (ISAAC) - Phase 3. J Pediatr (Rio J). 2006 Sep-Oct;82(5):341-6. doi: 10.2223/JPED.1521. Epub 2006 Aug 28.

    PubMed 16951799
  • Bruzzese JM, Bonner S, Vincent EJ, Sheares BJ, Mellins RB, Levison MJ, Wiesemann S, Du Y, Zimmerman BJ, Evans D. Asthma education: the adolescent experience. Patient Educ Couns. 2004 Dec;55(3):396-406. doi: 10.1016/j.pec.2003.04.009.

    PubMed 15582346
  • Joseph CL, Peterson E, Havstad S, Johnson CC, Hoerauf S, Stringer S, Gibson-Scipio W, Ownby DR, Elston-Lafata J, Pallonen U, Strecher V; Asthma in Adolescents Research Team. A web-based, tailored asthma management program for urban African-American high school students. Am J Respir Crit Care Med. 2007 May 1;175(9):888-95. doi: 10.1164/rccm.200608-1244OC. Epub 2007 Feb 8.

    PubMed 17290041
  • Sole D, Camelo-Nunes IC, Wandalsen GF, Mallozi MC, Naspitz CK; Brazilian ISAAC's Group. Is the prevalence of asthma and related symptoms among Brazilian children related to socioeconomic status? J Asthma. 2008 Jan-Feb;45(1):19-25. doi: 10.1080/02770900701496056.

    PubMed 18259991
  • Akinbami LJ, Schoendorf KC. Trends in childhood asthma: prevalence, health care utilization, and mortality. Pediatrics. 2002 Aug;110(2 Pt 1):315-22. doi: 10.1542/peds.110.2.315.

    PubMed 12165584
  • Bateman ED, Hurd SS, Barnes PJ, Bousquet J, Drazen JM, FitzGerald JM, Gibson P, Ohta K, O'Byrne P, Pedersen SE, Pizzichini E, Sullivan SD, Wenzel SE, Zar HJ. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008 Jan;31(1):143-78. doi: 10.1183/09031936.00138707.

    PubMed 18166595

Questions about this trial

What is this clinical trial studying?

A study testing Knowledge about Asthma and Respiratory Education (KARE) in people with Asthma, run by Federal University of Bahia at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Knowledge about asthma in adolescents of a public school in Salvador-Bahia- Brazil at 3 months (time frame: Baseline; up to 2 weeks; up to 3 months; up to 1 year after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02142179, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016.

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