Asthma in Central Texas Project
2. april 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
292
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Texas
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Austin, Texas, Forenede Stater, 78712
- The University of Texas at Austin
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
6 år til 13 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Andre navne:
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Eksperimentel: 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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|
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Sham-komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Absenteeism, End of Study
Tidsramme: 12 months
|
(Days absent/days enrolled)x100 = absenteeism.
Using data provided by the school district at the end of the study year.
|
12 months
|
|
Quality of Life, End of Study
Tidsramme: 12 months
|
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
|
|
Number of Days Hospitalized, During Study Year
Tidsramme: 12 months
|
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
Tidsramme: 12 months
|
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
Tidsramme: 12 months before baseline
|
Number of times hospitalized for asthma.
Data is obtained from parents for the pre-study year for the previous 12 months.
|
12 months before baseline
|
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Absenteeism Pre-study Year
Tidsramme: 12 months before baseline
|
(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
Tidsramme: 12 months before baseline
|
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
Tidsramme: 12 months
|
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
|
|
Emergency Department Visits, Pre-study Year
Tidsramme: 12 months before baseline
|
Number of visits to Emergency Department for asthma.
Data is obtained from parents for the pre-study year for the previous 12 months.
|
12 months before baseline
|
|
Quality of Life, Pre-study Year
Tidsramme: 12 months before baseline
|
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.
|
12 months before baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Asthma Self-management, Time 4
Tidsramme: Time 4, at 12 months
|
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
Tidsramme: 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
Tidsramme: Time 4 at 12 months
|
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
Tidsramme: Time 4 at 12 months
|
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
Tidsramme: Time 3 at 9 months
|
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.
|
Time 3 at 9 months
|
|
Asthma Self-management, Time 2
Tidsramme: Time 2 at 5 months
|
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.
|
Time 2 at 5 months
|
|
Asthma Self-management, Time 1, Baseline
Tidsramme: Time 1, baseline
|
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.
|
Time 1, baseline
|
|
Home Asthma Management, Time 1, Baseline
Tidsramme: Time 1, baseline
|
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.
Tidsramme: 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
Tidsramme: Time 3 at 9 months
|
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.
|
Time 3 at 9 months
|
|
Metered Dose Inhaler Skill, Time 3
Tidsramme: Time 3 at 9 months
|
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.
|
Time 3 at 9 months
|
|
Metered Dose Inhaler Skill, Time 2
Tidsramme: Time 2 at 5 months
|
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.
|
Time 2 at 5 months
|
|
Metered Dose Inhaler Skill, Time 1
Tidsramme: Time 1 at baseline
|
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.
|
Time 1 at baseline
|
|
Medication Adherence, Time 1
Tidsramme: Time 1 at baseline
|
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.
|
Time 1 at baseline
|
|
Medication Adherence, Time 2
Tidsramme: Time 2 at 5 months
|
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.
|
Time 2 at 5 months
|
|
Medication Adherence, Time 3
Tidsramme: Time 3 at 9 months
|
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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Lung Inflammation, Time 4
Tidsramme: Time 4 at 12 months
|
Exhaled breath condensation collected and sent for lab analysis of NO3.
Data collected at Time 4 visit.
Higher values represent greater airway inflammation.
|
Time 4 at 12 months
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Lung Inflammation, Time 1
Tidsramme: Time 1 at baseline
|
Exhaled breath condensation collected and sent for lab analysis of NO3.
Data collected at Time 1 visit.
Higher values represent greater airway inflammation.
|
Time 1 at baseline
|
|
Lung Inflammation, Time 2
Tidsramme: Time 2 at 5 months
|
Exhaled breath condensation collected and sent for lab analysis of NO3.
Data collected at Time 2 visit.
Higher values represent greater airway inflammation.
|
Time 2 at 5 months
|
|
Lung Inflammation, Time 3
Tidsramme: Time 3 at 9 months
|
Exhaled breath condensation collected and sent for lab analysis of NO3.
Data collected at Time 3 visit.
Higher values represent greater airway inflammation.
|
Time 3 at 9 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2008
Primær færdiggørelse (Faktiske)
1. september 2013
Studieafslutning (Faktiske)
1. november 2014
Datoer for studieregistrering
Først indsendt
24. august 2012
Først indsendt, der opfyldte QC-kriterier
30. august 2012
Først opslået (Skøn)
31. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. april 2015
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01NR007770 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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