Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics (PCC)
Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Asthma continues to be a major public health problem in the US with high economic and social costs. Vulnerable ethnic communities are disproportionately affected by asthma as demonstrated by higher morbidity and mortality for these groups. We have completed two school-based, randomized trials of a web-based, computer-tailored asthma management intervention that targets urban teens (Puff City).
The current study, Puff City in the Clinic, will be evaluated as a clinical tool by initiating the web-based behavioral intervention of asthma management in a clinical setting. However, the current paradigm for conducting such a trial is costly with respect to patient recruitment, intervention delivery, and data collection and management. To address these high costs, the study utilizes comparative effectiveness research (CER) pragmatic approaches to design a randomized controlled trial for patient recruitment and determination of eligibility, study monitoring (compliance with study regimen, participant retention and follow-up), and collection of clinical endpoints.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Health System
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 13-19 years of age
- Must be able to provide electronic assent and have consent from a parent/guardian if applicable
Diagnosis of asthma by meeting one of the following criteria within the last 12 months:
- At least one emergency department diagnosis of asthma or
- At least one acute inpatient encounter with asthma as the principal diagnosis or
- At least four outpatient visits with an asthma diagnosis and at least 2 asthma medications dispensed or
- At least four asthma medications dispensed
Exclusion Criteria:
- Inability to provide informed consent/assent
- Lack of physician diagnosis of asthma
- Other co-morbidities that make it impossible for the individual to participate.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Tailored asthma management program
Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.
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Web-based, computer-tailored asthma management intervention delivered in 4 sessions, plus a 6 month booster.
|
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Aktiv komparator: Control
Teens in the control group will receive generic, web-based asthma education.
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Web-based, generic asthma management intervention delivered in 4 sessions.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Asthma Control Test (ACT)
Tidsramme: 12 Months
|
Comparison of ACT scores at 12 months after the randomization
|
12 Months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Asthma Exacerbations/Functional Status
Tidsramme: 12 Months
|
Comparison of asthma exacerbations (asthma hospitalizations, emergency department visits, or oral corticosteroid dispensing)and functional status(e.g.
self report of symptom-days, symptom nights, days of restricted activity, school/work days missed) at 12 months after randomization.
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12 Months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The Cost
Tidsramme: Up to 12 months
|
The cost of study intervention will be evaluated: The cost for participant enrollment with Electronic Medical Record (EMR) initiation; data collection and management with/o EMR initiation including assessing the reliability of EMR clinical outcomes/primary endpoints, compared to chart abstraction.
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Up to 12 months
|
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The Cost Effectiveness
Tidsramme: Up to 12 months
|
The cost effectiveness of Puff City intervention compared to controls without study intervention.
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Up to 12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Christine Joseph, PhD, Henry Ford Health System
- Hovedetterforsker: Mei Lu, PhD, Henry Ford Health System
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1R01HL114981-01 (U.S. NIH-stipend/kontrakt)
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