Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence (SB-PACT)

31 december 2013 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Interventionell

Inskrivning (Faktisk)

99

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • New York
      • Rochester, New York, Förenta staterna, 14642
        • Univeristy of Rochester

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

3 år till 10 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria (all 4 criteria must be met):

  1. Physician-diagnosed asthma (based on parent report).
  2. Persistent asthma (criteria based on NHLBI guidelines). Any 1 of the following:

    1. An average of >2 days per week with asthma symptoms
    2. >2 days per week with rescue medication use
    3. >2 days per month with nighttime symptoms
    4. ≥2 episodes of asthma during the past year that have required systemic corticosteroids
  3. Age ≥3 and ≤10 years.
  4. Attending school in participating Rochester City School District preschools or elementary schools.

Exclusion Criteria:

  1. Inability to speak and understand English. (*Parents unable to read will be eligible, and all instruments will be given verbally.)
  2. No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate phone number).
  3. Family planning to leave the school district within fewer than 6 months.
  4. 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.
  5. Children in foster care or other situations in which consent cannot be obtained from a guardian.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups)
Tidsram: Average number of days, over 2 weeks, throughout the school year
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.
Average number of days, over 2 weeks, throughout the school year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cost Effectiveness
Tidsram: one year
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.
one year
Feasibility and Acceptability
Tidsram: one year
We will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population.
one year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Jill S. Halterman, MD, MPH, University of Rochester

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2010

Primärt slutförande (Faktisk)

1 augusti 2011

Avslutad studie (Faktisk)

1 augusti 2012

Studieregistreringsdatum

Först inskickad

16 april 2010

Först inskickad som uppfyllde QC-kriterierna

3 augusti 2010

Första postat (Uppskatta)

4 augusti 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

17 februari 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 december 2013

Senast verifierad

1 december 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 32479
  • 1RC1HL099432-01 (U.S.S. NIH-anslag/kontrakt)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på School-Based Medication Delivery

3
Prenumerera