NCT02142179

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 7, 2016

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

May 11, 2014

Last Update Submit

July 6, 2016

Conditions

Keywords

AsthmaKnowledgeSchool-Based ServiceAdolescents

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (6)

  • Visits to emergency in the subgroup of patients with asthma/ symptoms suggestive of asthma

    Baseline; up to 2 weeks and up to 3 months

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

    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

    Baseline; up to 2 weeks and up to 3 months

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

    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

    Baseline; up to 2 weeks and up to 3 months

  • +1 more secondary outcomes

Study Arms (2)

KARE Intervention

EXPERIMENTAL

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.

Behavioral: Knowledge about Asthma and Respiratory Education (KARE)

A traditional curriculum education.

NO INTERVENTION

The control group will receive a traditional curriculum education.

Interventions

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 Intervention

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, Brazil

Location

Related Publications (7)

  • 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.

    PMID: 21139088BACKGROUND
  • 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.

    PMID: 16951799BACKGROUND
  • 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.

    PMID: 15582346BACKGROUND
  • 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.

    PMID: 17290041BACKGROUND
  • 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.

    PMID: 18259991BACKGROUND
  • 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.

    PMID: 12165584BACKGROUND
  • 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.

    PMID: 18166595BACKGROUND

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Adelmir Souza-Machado, PHD

    Federal University of Bahia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
NP, Msc

Study Record Dates

First Submitted

May 11, 2014

First Posted

May 20, 2014

Study Start

November 1, 2012

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

July 7, 2016

Record last verified: 2016-07

Locations