Asthma in Central Texas Project
2 april 2015 bijgewerkt door: University of Texas at Austin
Enhancing Children's and Parents' Asthma Management
Asthma is the most common chronic childhood illness and disproportionately affects children who are ethnic minorities and poor.
Few studies of childhood asthma have been conducted with children who live in rural areas or have included Mexican American children in their samples.
This study builds on the original R01NR007770 with findings that demonstrated the intervention could improve children's asthma self-management, asthma knowledge, metered dose inhaler skill, asthma severity, and parents' asthma management and access to care.
In this competing continuation, the investigators added a third arm to the current research design with schools randomized into either an in-school asthma intervention, an in-school attention-control intervention, or an alternate intervention-delivery format of a single 5.5-hour asthma day camp.
The tri-ethnic sample will be composed of 320 Mexican-American, African-American, and White rural school-aged children (grades 2-5) who have asthma and their parents.
In addition, the investigators propose adding a non-invasive measure of chronic airway inflammation (exhaled nitric oxide) to assess the impact of changes in asthma management on airway inflammation.
Families will be followed for a full year with data collection at baseline and at 1-month, 4-months, and 7-months after the intervention to assess improvement in children's asthma morbidity, asthma severity, airway inflammation, family asthma management and quality of life.
Hypotheses (H): Children in the Camp-Workshop group and the School-Home group will demonstrate equivalent improvements, but greater improvements than the Attention-Control group in:(H1.1)
their asthma severity and airway inflammation from the Time 1 assessment when compared to Time 4 assessment; (H1.2) office visits, ED visits, and hospitalizations for asthma, and absenteeism for the study year (Time 4) when compared to the pre-study year (Time 1); and (H1.4) Parents in the intervention arms will demonstrate sustained improvements in asthma caregiver's quality of life (QOL0 from the pre-study year (Time 1) to the end of the study year (Time 4) measurement, when compared to the Attention-Control group.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Families are recruited at the beginning of the school year (Time 1, October-November); parents consent and child assent obtained and baseline data collected in fall.
The intervention is provided in December-January.
Follow-up data are collected at February (Time 2), April (Time 3), and August (Time 4).
Studietype
Ingrijpend
Inschrijving (Werkelijk)
292
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Texas
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Austin, Texas, Verenigde Staten, 78712
- The University of Texas at Austin
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
6 jaar tot 13 jaar (Kind)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- parent reports the child has a diagnosis of asthma made by a medical provider;
- has had asthma symptoms in the previous 12 months;
- speaks either English or Spanish.
Exclusion Criteria:
- has a significant co-morbidity that would preclude participation in classes (e.g., severe cerebral palsy, oxygen dependent conditions)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Asthma in-school class
Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week.
The content is provided by trained asthma educators.
The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms.
Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation.
Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g.
teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
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Andere namen:
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Experimenteel: Asthma Day Camp
The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff.
The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g.
teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
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Sham-vergelijker: Health Promotion in-school class
The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week.
The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Absenteeism, End of Study
Tijdsspanne: 12 months
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(Days absent/days enrolled)x100 = absenteeism.
Using data provided by the school district at the end of the study year.
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12 months
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Quality of Life, End of Study
Tijdsspanne: 12 months
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Self reported asthma-related quality of life.
Outcome data were collected at end of study (Time 4).
The Pediatric Asthma Quality of Life scale.
Minimum score 23 to maximum score of 115.
A higher score indicates worse quality of life.
Mean scale scores are computed.
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12 months
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Number of Days Hospitalized, During Study Year
Tijdsspanne: 12 months
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Number of days hospitalized for asthma.
Data were obtained from parent report at the second, third, and fourth data collection point.
The number of hospitalization days were summed for a total number at the end of the 12 months.
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12 months
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Emergency Department Visits, Study Year
Tijdsspanne: 12 months
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Number of visits to Emergency Department for asthma.
Data is obtained from parents at three time points (time 2, 3, and 4) and summed for total number of visits to the emergency department for asthma during the study year.
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12 months
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Number of Asthma Hospitalizations Pre-Study Year
Tijdsspanne: 12 months before baseline
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Number of times hospitalized for asthma.
Data is obtained from parents for the pre-study year for the previous 12 months.
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12 months before baseline
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Absenteeism Pre-study Year
Tijdsspanne: 12 months before baseline
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(Days absent/days enrolled)x100 = absenteeism.
Using data for the 12 months prior to study enrollment as the pre-study year.
Data is provided by the participating school districts.
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12 months before baseline
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Number of Days in Hospital for Asthma, Pre-Study Year
Tijdsspanne: 12 months before baseline
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Number of days hospitalized for asthma.
Data is obtained from parents for the pre-study year for the previous 12 months.
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12 months before baseline
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Number of Asthma Hospital Stays, During Study Year
Tijdsspanne: 12 months
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Number of hospital admissions for asthma.
Data were obtained from parent report at the second, third, and fourth data collection point.
The number of hospitalizations were summed for a total number at the end of the 12 months.
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12 months
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Emergency Department Visits, Pre-study Year
Tijdsspanne: 12 months before baseline
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Number of visits to Emergency Department for asthma.
Data is obtained from parents for the pre-study year for the previous 12 months.
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12 months before baseline
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Quality of Life, Pre-study Year
Tijdsspanne: 12 months before baseline
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Self reported asthma-related quality of life.
Data were collected at study enrollment (time 1).
The Pediatric Asthma Quality of Life scale.
Minimum score 23 to maximum score of 115.
A higher score indicates worse quality of life.
Mean scale scores are computed.
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12 months before baseline
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Asthma Self-management, Time 4
Tijdsspanne: Time 4, at 12 months
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Child self-report of asthma preventive and management activities, collected at each of 4 time points.
This is the Time 4, final measure.
Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
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Time 4, at 12 months
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Home Asthma Management, Time 4, End of Study
Tijdsspanne: Time 4 at 12 months
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Parent report of asthma preventive and treatment activities.
Data collected at final study visit, Time 4. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
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Time 4 at 12 months
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Metered Dose Inhaler Skill, Time 4
Tijdsspanne: Time 4 at 12 months
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Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler).
Observation data recorded by trained data collectors.
8-item scale listing the steps to perform proper inhalation technique.
Number of correct steps are summed.
Higher score = better skill in using inhaler.
Collected at final, time 4 data visit.
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Time 4 at 12 months
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Medication Adherence, Time 4
Tijdsspanne: Time 4 at 12 months
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Parent report of their child remembering/forgetting to take medications.
4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items.
Range 0-4, higher score means worse adherence.
Data are collected at final data point, Time 4.
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Time 4 at 12 months
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Asthma Self-management, Time 3
Tijdsspanne: Time 3 at 9 months
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Child self-report of asthma preventive and management activities, collected at each of 4 time points.
This is the Time 3 measure.
Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
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Time 3 at 9 months
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Asthma Self-management, Time 2
Tijdsspanne: Time 2 at 5 months
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Child self-report of asthma preventive and management activities, collected at each of 4 time points.
This is the Time 2 measure.
Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
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Time 2 at 5 months
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Asthma Self-management, Time 1, Baseline
Tijdsspanne: Time 1, baseline
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Child self-report of asthma preventive and management activities, collected at each of 4 time points.
This is the baseline, Time 1 measure.
Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
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Time 1, baseline
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Home Asthma Management, Time 1, Baseline
Tijdsspanne: Time 1, baseline
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Parent report of asthma preventive and treatment activities.
Data are collected at study enrollment, Time 1, baseline visit.
Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
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Time 1, baseline
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Home Asthma Management, Time 2.
Tijdsspanne: Time 2 at 5 months
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Parent report of asthma preventive and treatment activities.
Data collected at the time 2 visit.
Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
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Time 2 at 5 months
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Home Asthma Management, Time 3
Tijdsspanne: Time 3 at 9 months
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Parent report of asthma preventive and treatment activities.
Data collected at third time point (Time 3).
Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
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Time 3 at 9 months
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Metered Dose Inhaler Skill, Time 3
Tijdsspanne: Time 3 at 9 months
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Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler).
Observation data recorded by trained data collectors.
8-item scale listing the steps to perform proper inhalation technique.
Number of correct steps are summed.
Higher score = better skill in using inhaler.
Collected at time 3 data visit.
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Time 3 at 9 months
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Metered Dose Inhaler Skill, Time 2
Tijdsspanne: Time 2 at 5 months
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Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler).
Observation data recorded by trained data collectors.
8-item scale listing the steps to perform proper inhalation technique.
Number of correct steps are summed.
Higher score = better skill in using inhaler.
Collected at final, time 2 data visit.
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Time 2 at 5 months
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Metered Dose Inhaler Skill, Time 1
Tijdsspanne: Time 1 at baseline
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Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler).
Observation data recorded by trained data collectors.
8-item scale listing the steps to perform proper inhalation technique.
Number of correct steps are summed.
Higher score = better skill in using inhaler.
Collected at enrollment visit, Time 1 data visit.
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Time 1 at baseline
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Medication Adherence, Time 1
Tijdsspanne: Time 1 at baseline
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Parent report of their child remembering/forgetting to take medications.
4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items.
Range 0-4, higher score means worse adherence.
Data are collected at study enrollment, Time 1.
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Time 1 at baseline
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Medication Adherence, Time 2
Tijdsspanne: Time 2 at 5 months
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Parent report of their child remembering/forgetting to take medications.
4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items.
Range 0-4, higher score means worse adherence.
Data are collected at Time 2 visit.
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Time 2 at 5 months
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Medication Adherence, Time 3
Tijdsspanne: Time 3 at 9 months
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Parent report of their child remembering/forgetting to take medications.
4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items.
Range 0-4, higher score means worse adherence.
Data are collected at Time 3 visit.
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Time 3 at 9 months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Lung Inflammation, Time 4
Tijdsspanne: Time 4 at 12 months
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Exhaled breath condensation collected and sent for lab analysis of NO3.
Data collected at Time 4 visit.
Higher values represent greater airway inflammation.
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Time 4 at 12 months
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Lung Inflammation, Time 1
Tijdsspanne: Time 1 at baseline
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Exhaled breath condensation collected and sent for lab analysis of NO3.
Data collected at Time 1 visit.
Higher values represent greater airway inflammation.
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Time 1 at baseline
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Lung Inflammation, Time 2
Tijdsspanne: Time 2 at 5 months
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Exhaled breath condensation collected and sent for lab analysis of NO3.
Data collected at Time 2 visit.
Higher values represent greater airway inflammation.
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Time 2 at 5 months
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Lung Inflammation, Time 3
Tijdsspanne: Time 3 at 9 months
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Exhaled breath condensation collected and sent for lab analysis of NO3.
Data collected at Time 3 visit.
Higher values represent greater airway inflammation.
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Time 3 at 9 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2008
Primaire voltooiing (Werkelijk)
1 september 2013
Studie voltooiing (Werkelijk)
1 november 2014
Studieregistratiedata
Eerst ingediend
24 augustus 2012
Eerst ingediend dat voldeed aan de QC-criteria
30 augustus 2012
Eerst geplaatst (Schatting)
31 augustus 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
24 april 2015
Laatste update ingediend die voldeed aan QC-criteria
2 april 2015
Laatst geverifieerd
1 april 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R01NR007770 (Subsidie/contract van de Amerikaanse NIH)
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