Status:
COMPLETED
HERO-2: Home-Reported Outcomes With CFTR Modulator Therapy
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Folia Health
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Brief Summary
This is an observational cohort study, using data from Folia Health and the Cystic Fibrosis Foundation Patient Registry (CFFPR). Individuals taking elexacaftor/tezacaftor/ivacaftor (ETI) may be enroll...
Detailed Description
This study will be a prospective, observational cohort study to investigate the changes in lung function among individuals who have made treatment changes after initiating treatment with elexacaftor/t...
Eligibility Criteria
Inclusion
- Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian.
- Is willing and able to adhere to protocol requirements.
- ≥ 12 years of age at enrollment.
- Diagnosed with CF.
- Prescribed ETI for an on-label indication.
- Participant has access to a mobile phone or tablet (iPhone or Android platform) or computer.
- Participant has access to an internet connection.
Exclusion
- Participant is enrolled in the randomized portion of the SIMPLIFY study (NCT04378153).
- Participant does not have access to the necessary technology.
- Participant is a recipient of a solid organ transplant (i.e. lung, liver, pancreas, kidney).
- Participant cannot communicate in English.
Key Trial Info
Start Date :
May 26 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 15 2023
Estimated Enrollment :
860 Patients enrolled
Trial Details
Trial ID
NCT04798014
Start Date
May 26 2021
End Date
August 15 2023
Last Update
May 2 2024
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202