School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence (SB-PACT)
31. december 2013 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
99
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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New York
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Rochester, New York, Forenede Stater, 14642
- Univeristy of Rochester
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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
3 år til 10 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Ingen indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Cost Effectiveness
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jill S. Halterman, MD, MPH, University of Rochester
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
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. august 2010
Primær færdiggørelse (Faktiske)
1. august 2011
Studieafslutning (Faktiske)
1. august 2012
Datoer for studieregistrering
Først indsendt
16. april 2010
Først indsendt, der opfyldte QC-kriterier
3. august 2010
Først opslået (Skøn)
4. august 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. februar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. december 2013
Sidst verificeret
1. december 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 32479
- 1RC1HL099432-01 (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 .
Kliniske forsøg med School-Based Medication Delivery
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