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ObservationalClosed to Enrollment
HERO-2, protocol number HERO2-OB-2
This is a real-world observational study to assess the impact of Trikafta therapy on the daily use of chronic CF medications and treatments in PwCF using a novel phone-based, patient-reported outcomes application (Folia Health) and data from the CF Foundation Patient Registry. We will determine the proportion and clinical features of PwCF taking Trikafta who make changes to their chronic daily therapies and assess the relationship between changes in chronic daily therapies in PwCF taking Trikafta using data from the CF Registry. Trikafta and other medications will not be prescribed as part of the study. Participants may be enrolled at participating sites, through social media recruitment, or from existing users of Folia Health. Participation in the study will occur through the Folia application, which is accessed through iPhones, Android phones, and desktop computers. Study participants will be asked to complete an initial survey, log into the app to provide daily data on symptoms and medication use, and complete monthly surveys regarding their symptoms and medication use for 12 months using Folia. Participants are encouraged to track daily, but can “batch track” and provide 7 days of data at once (compensation is based on a minimum of three days of data each week).
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Age:
12 Years and Older
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Mutation(s):
No Mutation Requirement
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FEV1% Predicted:
No FEV1 Limit
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Number of Visits:
0
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Length of Participation:
12 months
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