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Clinical Trial Finder
Observational Closed to Enrollment
HERO-2 (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).
Participants can self-enroll in this study from any location in the United States.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
12 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants in this study must be taking Trikafta and have access to the internet. Participants should not be in the randomized portion of the SIMPLIFY data.
Participants can self-enroll in this study from any location in the United States.
Study Design
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Study Type: ?more info
Observational -
Randomized Study: ?more info
No -
Placebo Controlled: ?more info
No -
Length of Participation:
12 months -
Number of Study Visits:
0
Additional Information
-
Phase: ?more info
Not Applicable -
Study Sponsor: ?more info
Brown, Cynthia -
Study Drugs:
N/A
Study Sites
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Closed to Enrollment
California
Center for Cystic Fibrosis at Keck Medical Center of USC, Los Angeles, CA 90033
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Closed to Enrollment
California
Long Beach Memorial Medical Center, Long Beach, CA 90806
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Closed to Enrollment
Florida
All Children's Hospital, St. Petersburg, FL 33701
-
Closed to Enrollment
Florida
Tampa General Hospital, Tampa, FL 33606
-
Closed to Enrollment
Georgia
Augusta University, Augusta, GA 30912
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Closed to Enrollment
Georgia
Augusta University, Augusta, GA 30912
-
Closed to Enrollment
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
-
Closed to Enrollment
Indiana
Indiana University Medical Center, Indianapolis, IN 46202
-
Closed to Enrollment
Kentucky
University of Louisville, Louisville, KY 40202
-
Closed to Enrollment
Maine
Maine Medical Partners Pediatric Specialty Care, Portland, ME 04102
-
Closed to Enrollment
Michigan
University of Michigan Health System, Ann Arbor, MI 48109
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Closed to Enrollment
Michigan
Wayne State University Harper University Hospital, Detroit, MI 48201
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Closed to Enrollment
Michigan
Children's Hospital of Michigan, Detroit, MI 48201
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Closed to Enrollment
Minnesota
The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455
-
Closed to Enrollment
Missouri
SSM Health Cardinal Glennon Children’s Hospital, St. Louis, MO 63104
-
Closed to Enrollment
New Jersey
Morristown Medical Center , Morristown, NJ 07960
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Closed to Enrollment
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
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Closed to Enrollment
New York
Cohen Children's Medical Center of New York, Lake Success, NY 11042
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Closed to Enrollment
Ohio
Dayton Children's Hospital, Dayton, OH 45404
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Closed to Enrollment
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
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Closed to Enrollment
Oregon
Oregon Health & Science University, Portland, OR 97239
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Closed to Enrollment
Pennsylvania
Children's Hospital of Philadelphia, Philadelphia, PA 19104
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Closed to Enrollment
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
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Closed to Enrollment
Pennsylvania
Jefferson University Hospital, Philadelphia, PA 19107
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Closed to Enrollment
Tennessee
University of Tennessee Medical Center, Knoxville, TN 37920
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Closed to Enrollment
Tennessee
Vanderbilt University Medical Center, Nashville, TN 37232
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Closed to Enrollment
Utah
Intermountain Cystic Fibrosis Center, University of Utah, Salt Lake City, UT 84132
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Closed to Enrollment
Virginia
Children's Hospital of The King's Daughters, Norfolk, VA 23507
-
Closed to Enrollment
Wisconsin
Children's Hospital of Wisconsin, Milwaukee, WI 53226
Eligibility
See other primary eligibility criteria for more information.
-
Age:
12 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants in this study must be taking Trikafta and have access to the internet. Participants should not be in the randomized portion of the SIMPLIFY data.
Participants can self-enroll in this study from any location in the United States.
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