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HERO-2: Home-Reported Outcomes With CFTR Modulator Therapy

NCT04798014 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 860

Last updated 2024-05-02

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Folia Health

    collaborator INDUSTRY

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Indiana University

    lead OTHER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-26
Primary Completion
2023-08-15
Completion
2023-08-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04798014 on ClinicalTrials.gov