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HERO-2: Home-Reported Outcomes With CFTR Modulator Therapy
Sponsor: Indiana University
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 enrolled through the Folia application. During the 12-month study period, participants will be asked to track their routine treatment and medication usage, daily symptoms, and monthly review with validated patient-reported outcome (PRO) questionnaires. Participants will also be asked to self-report instances of changes to their treatment plan, and pulmonary exacerbations. There are no study-associated site visits.
Official title: Home-Reported Outcomes in People With Cystic Fibrosis (CF) Taking Highly Effective Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulator Therapy
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
OBSERVATIONAL
Enrollment
860
Start Date
2021-05-26
Completion Date
2023-08-15
Last Updated
2026-07-28
Healthy Volunteers
No
Conditions
Locations (1)
Indiana University School of Medicine
Indianapolis, Indiana, United States