- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00921401
Improving the Quality of Asthma Care Using the Internet
Studieöversikt
Detaljerad beskrivning
Asthma is a common cause of illness and lost productivity, including missed days of work and school, in the United States. It is important for people with asthma to become involved in their treatment and care. Previous studies have shown that encouraging people to ask their doctor for various medical tests and treatments improves preventive care (e.g., cancer screenings), but more research is needed on the effect this can have on asthma management. This study will involve an interactive Web site that will ask patients questions about their asthma symptoms and medications and provide suggestions and feedback on the types of questions patients may want to ask their doctors. By asking questions about their asthma care and increasing communication with their doctor, patients may experience improved quality of asthma care and better asthma control. The purpose of this study is to evaluate the impact of the interactive Web site on asthma control and other measures of asthma management.
This 12-month study will enroll people with asthma. Participants will be randomly assigned to either the Asthma Feedback group or the Preventive Feedback (control) group. Both groups will log in to the study Web site at least once a month for 12 months and before all doctor visits. After logging in to the Web site, participants in the Asthma Feedback group will answer a series of questions about their asthma care. They will then receive information and feedback on the types of questions they should ask their asthma care provider during their next office visit. Participants in the Preventive Feedback group will answer questions and receive information and feedback regarding preventive services (e.g., cancer screening, cholesterol screening) that they should discuss with their primary care provider. At baseline and Months 6 and 12, all participants will complete online questionnaires regarding their asthma and overall health. Study researchers will review participants' medical records and insurance claims data at the end of the study.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
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Pennsylvania
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Hershey, Pennsylvania, Förenta staterna, 17033
- Penn State Hershey Medical Center, Penn State College of Medicine
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Only individuals with persistent asthma will be considered for this study. These definitions are made based on definitions from the National Committee for Quality Assurance (NCQA) and include individuals who meet either criteria A or B:
- A: (Four or more prescription medications used for asthma treatment in 1 year) OR (One or more visits to the emergency room with a principal diagnosis of asthma in 1 year) OR (One or more inpatient hospital visits with a principal diagnosis of asthma in 1 year)
- B: (Four or more outpatient visits with any diagnosis of asthma) AND (two or more claims for a prescription drug used for asthma treatment in 1 year)
Other Inclusion Criteria:
- Speaks and reads English fluently
- Member of Highmark
- Has access to the Internet at home or at work
- Has a valid e-mail address
- No history of more than 20 pack-years of cigarette smoking
- Enrolled in a Highmark health plan offering that includes prescription drug coverage
Exclusion Criteria:
- Does not speak English
- Does not have Internet access at home or work
- Smoked more than 20 pack-years (to exclude possible chronic obstructive pulmonary disease [COPD])
- Does not currently have asthma
- Pregnant
- Unwilling to consent
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Asthma Feedback
Each month and before all visits with their asthma care provider, participants will be encouraged to go online and answer a series of questions regarding the types of asthma medications they use and how often they use them, asthma symptoms they have experienced, emergency department visits in the past year, the care they have received for their asthma (e.g., specialist visits) in the past year, and the planned date of their next visit with their asthma care provider.
Participants will receive tailored feedback about what questions they should ask their doctor during a subsequent visit, whether or not they should schedule a visit sooner, and links to read more about each recommendation.
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All participants will log in to the study Web site at least once a month and before all doctor visits.
They will answer a series of questions and receive individualized feedback about the types of questions they should ask their doctor.
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Aktiv komparator: Preventive Feedback
Each month and before all visits with their primary care provider, participants will be encouraged to go online and answer a series of questions regarding their preventive care.
They will receive tailored feedback regarding preventive services, such as pap testing, cancer screenings, and flu shots.
Participants will receive tailored feedback regarding preventive services (e.g., cancer screening) that they should discuss with their primary care provider.
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All participants will log in to the study Web site at least once a month and before all doctor visits.
They will answer a series of questions and receive individualized feedback about the types of questions they should ask their doctor.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Asthma control - as measured by the Asthma Control Test
Tidsram: Measured at Year 1
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Measured at Year 1
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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Medication adherence, as measured by claims data
Tidsram: Measured at Year 1
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Measured at Year 1
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Outpatient provider visits, as measured by claims data
Tidsram: Measured at Year 1
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Measured at Year 1
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Asthma-related emergency department visits, as measured by claims data
Tidsram: Measured at Year 1
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Measured at Year 1
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Christopher N Sciamanna, MD, MPH, Penn State University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 662
- 5R01HL088590-02 (U.S.S. NIH-anslag/kontrakt)
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