Asthma in Central Texas Project
Enhancing Children's and Parents' Asthma Management
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Texas
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Austin, Texas, Stati Uniti, 78712
- The University of Texas at Austin
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: 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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Altri nomi:
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Sperimentale: 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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Comparatore fittizio: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Absenteeism, End of Study
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Asthma Self-management, Time 4
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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Time 3 at 9 months
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Metered Dose Inhaler Skill, Time 2
Lasso di tempo: 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.
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Time 2 at 5 months
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Metered Dose Inhaler Skill, Time 1
Lasso di tempo: 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.
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Time 1 at baseline
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Medication Adherence, Time 1
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Lung Inflammation, Time 4
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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Time 3 at 9 months
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Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- R01NR007770 (Sovvenzione/contratto NIH degli Stati Uniti)
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