- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03036982
Remote Use of the Asthma Control Test (ACT) to Improve Care of Children With Asthma
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Asthma is the most prevalent chronic disease of childhood with an overall prevalence of 10%. While effective therapies exist to control symptoms and prevent exacerbations, many asthma patients experience significant morbidity including limitations on daily activities as well as asthma exacerbations that lead to missed school (and work for care givers) and necessitate emergency department visits and hospitalizations. Among children from lower socioeconomic statues and in black and Hispanic families, asthma incidence and severity are even greater. Reasons for this disparity included decreased access to effective asthma care, increased exposure to tobacco smoke and environmental allergens, and underutilization of controller medicines. These groups have significantly increased resource utilization due to emergency department visits and hospitalizations. Optimal care for asthma patients, especially those with at highest risk, will therefore require new strategies for evaluating ongoing control and providing direct feedback to patients.
We propose to transform the way asthma care is provided through the use of an innovative patient centered technology -Trivox Asthma - to improve quality of care and outcomes for asthma patients while reducing the cost of care. Specifically we will extend Trivox Health to facilitate closer monitoring of patients with asthma through the existing web platform and a new mobile interface. This will allow asthma patients, their parents and school nurses to remotely input data on asthma control through smartphones and/or tablets. We will use the ACT+, an expansion of a validated measure currently utilized in both primary care and specialty clinics, to measure both asthma control and risk.
Effectiveness of this intervention will be measured by examining resource utilization and ongoing asthma control.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Boston Childrens Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Diagnosis of asthma
- Cared for at Boston Children's Hospital (Primary or secondary care)
Exclusion Criteria:
- Age <4 or >21
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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Use of Mobile ACT
Will answer ACT (or cACT) and other asthma questions using mobile app
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Well-controlled asthma
Tidsram: Each month for one calendar year
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Percent of ACT scores with value of 20 or greater
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Each month for one calendar year
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Asthma Emergency Department visits and hospitalizations
Tidsram: Total Emergency Department Visits and hospitalizations with asthma as one of top diagnosis in one year
|
Asked every 3 months
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Total Emergency Department Visits and hospitalizations with asthma as one of top diagnosis in one year
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Andrew MacGinnitie, MD PhD, Boston Children's Hosptial
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FP01013808
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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