School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence (SB-PACT)
31 décembre 2013 mis à jour par: Jill Halterman, University of Rochester
School-Based Preventive Asthma Care Technology: A Randomized Control Trial Using a Novel Technology to Improve Adherence
The goal of this new translational project is to test the feasibility and effectiveness of implementing school-based directly observed therapy of preventive asthma medications in a real-world setting, using state-of-the-art web-based technology for systematic screening, electronic report generation, and communication between nurses, caregivers, and primary care providers.
With the use of a novel method to improve adherence and subsequently reduce morbidity, the investigators hypothesize that this novel adaptation of school-based asthma care will; 1) be feasible and acceptable among this population and among school and community stakeholders, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care).
The investigators anticipate that enhancing preventive healthcare for young urban children with asthma through partnerships with the schools using a novel technology will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
99
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New York
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Rochester, New York, États-Unis, 14642
- Univeristy of Rochester
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
3 ans à 10 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria (all 4 criteria must be met):
- Physician-diagnosed asthma (based on parent report).
Persistent asthma (criteria based on NHLBI guidelines). Any 1 of the following:
- An average of >2 days per week with asthma symptoms
- >2 days per week with rescue medication use
- >2 days per month with nighttime symptoms
- ≥2 episodes of asthma during the past year that have required systemic corticosteroids
- Age ≥3 and ≤10 years.
- Attending school in participating Rochester City School District preschools or elementary schools.
Exclusion Criteria:
- Inability to speak and understand English. (*Parents unable to read will be eligible, and all instruments will be given verbally.)
- No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate phone number).
- Family planning to leave the school district within fewer than 6 months.
- The child having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
- Children in foster care or other situations in which consent cannot be obtained from a guardian.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: School-Based Medication Group
For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school.
If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy.
The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
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For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school.
If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy.
The child's school nurse begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
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Aucune intervention: Usual Care Group
Children in the Usual Care group will not receive preventive medications delivered at school.
These children will continue to receive all of their asthma care from their parents and primary care physicians.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups)
Délai: Average number of days, over 2 weeks, throughout the school year
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The primary outcome is asthma morbidity between groups.
We will measure asthma morbidity by looking at the average number of symptom-free days, over 2 weeks, at each bi-monthly follow-up time point over the school year.
Number of days without asthma symptoms will be reported by the child's caregiver.
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Average number of days, over 2 weeks, throughout the school year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Cost Effectiveness
Délai: one year
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We will evaluate the cost effectiveness to implement and sustain the web-based system in schools.
We will review the cost of the intervention using three main categories of costs; programmatic costs (costs of initiating and running the program), productivity costs, and medical costs estimated at the individual child level.
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one year
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Feasibility and Acceptability
Délai: one year
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We will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population.
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one year
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jill S. Halterman, MD, MPH, University of Rochester
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Halterman JS, Sauer J, Fagnano M, Montes G, Fisher S, Tremblay P, Tajon R, Butz A. Working toward a sustainable system of asthma care: development of the School-Based Preventive Asthma Care Technology (SB-PACT) trial. J Asthma. 2012 May;49(4):395-400. doi: 10.3109/02770903.2012.669441. Epub 2012 Mar 28.
- Halterman JS, Fagnano M, Montes G, Fisher S, Tremblay P, Tajon R, Sauer J, Butz A. The school-based preventive asthma care trial: results of a pilot study. J Pediatr. 2012 Dec;161(6):1109-15. doi: 10.1016/j.jpeds.2012.05.059. Epub 2012 Jul 10.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 août 2010
Achèvement primaire (Réel)
1 août 2011
Achèvement de l'étude (Réel)
1 août 2012
Dates d'inscription aux études
Première soumission
16 avril 2010
Première soumission répondant aux critères de contrôle qualité
3 août 2010
Première publication (Estimation)
4 août 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
17 février 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 décembre 2013
Dernière vérification
1 décembre 2013
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 32479
- 1RC1HL099432-01 (Subvention/contrat des NIH des États-Unis)
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