Page Title
Clinical Trial Finder
Observational Enrolling
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.
Email a research coordinator to express interest in participating in this study.
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 a more comprehensive list of eligibility criteria and details on this study, 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
-
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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Enrolling Soon
California
Center for Cystic Fibrosis at Keck Medical Center of USC, Los Angeles, CA 90033
Contact
Lynn Fukushima
Phone: +1 (323) 409-5383
Email: lynn.fukushima@med.usc.edu
-
Enrolling Soon
California
Long Beach Memorial Medical Center, Long Beach, CA 90806
Contact
Marylee Melendrez
Phone: +1 (562) 933-1851
Email: mmelendrez@memorialcare.org
-
Enrolling
Florida
All Children's Hospital, St. Petersburg, FL 33701
Contact
Diana Hodge
Phone: +1 (727) 767-6881
Email: dhodge6@jhmi.edu
-
Enrolling Soon
Florida
Tampa General Hospital, Tampa, FL 33606
Contact
Andrew Marino
Phone: +1
Email: armarino@usf.edu
-
Enrolling
Georgia
Augusta University, Augusta, GA 30912
Contact
Heidi Stapp
Phone: +1 (706) 721-7699
Email: hstapp@augusta.edu
-
Enrolling Soon
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iu.edu
-
Enrolling
Indiana
Indiana University Medical Center, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iu.edu
-
Enrolling Soon
Kentucky
University of Louisville, Louisville, KY 40202
Contact
Melissa Thomas
Phone: +1
Email: mcthom12@louisville.edu
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Enrolling Soon
Maine
Maine Medical Partners Pediatric Specialty Care, Portland, ME 04102
Contact
Rebecca Edwards
Phone: +1 (207) 662-6712
Email: REdwards1@mmc.org
-
Enrolling Soon
Michigan
University of Michigan Health System, Ann Arbor, MI 48109
Contact
Dawn Kruse
Phone: +1 (734) 615-3266
Email: dmkruse@med.umich.edu
-
Enrolling Soon
Michigan
Wayne State University Harper University Hospital, Detroit, MI 48201
Contact
Debra Driscoll
Phone: +1 (313) 745-2221
Email: ddriscol@med.wayne.edu
-
Enrolling Soon
Minnesota
The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455
Contact
Participant Contact University of Minnesota
Phone: +1
Email: cftrials@umn.edu
-
Enrolling
Missouri
SSM Health Cardinal Glennon Children’s Hospital, St. Louis, MO 63104
Contact
Freda Branch
Phone: +1 (314) 678-5468
Email: freda.branch@health.slu.edu
-
Enrolling
New Jersey
Morristown Medical Center , Morristown, NJ 07960
Contact
Nancy Martinez
Phone: +1 (973) 971-5138
Email: nancy.martinez@atlantichealth.org
-
Enrolling
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
Contact
Zachary Messer
Phone: +1 (914) 594-2352
Email: Zachary_Messer@nymc.edu
-
Enrolling Soon
New York
Cohen Children's Medical Center of New York, Lake Success, NY 11042
Contact
Susan Galvin
Phone: +1 (516) 321-8606
Email: sgalvin@northwell.edu
-
Enrolling
Ohio
Dayton Children's Hospital, Dayton, OH 45404
Contact
Sandy Bartosik
Phone: +1 (937) 641-4004
Email: bartosiks@childrensdayton.org
-
Enrolling
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44146
Contact
Kathleen Hilliard
Phone: +1 (216) 844-7489
Email: kathleen.hilliard@uhhospitals.org
-
Enrolling
Oregon
Oregon Health Sciences University, Portland, OR 97239
Contact
Brendan Klein
Phone: +1 (503) 418-8108
Email: kleinb@ohsu.edu
-
Enrolling
Pennsylvania
Children's Hospital of Philadelphia, Philadelphia, PA 19104
Contact
Erin Donnelly
Phone: +1 (267) 426-9626
Email: Donnellye4@email.chop.edu
-
Enrolling
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
Contact
Melissa Molter
Phone: +1 (215) 662-3116
Email: melissa.molter@pennmedicine.upenn.edu
-
Enrolling Soon
Pennsylvania
Jefferson University Hospital, Philadelphia, PA 19107
Contact
Phone: +1
Email:
-
Enrolling
Tennessee
University of Tennessee Medical Center, Knoxville, TN 37920
Contact
Phone: +1
Email:
-
Enrolling Soon
Tennessee
Vanderbilt University Medical Center, Nashville, TN 37232
Contact
Brijesh Patel
Phone: +1 (615) 343-4865
Email: brijesh.patel@vumc.org
-
Enrolling
Utah
Intermountain Cystic Fibrosis Center, University of Utah, Salt Lake City, UT 84132
Contact
Kristyn Packer
Phone: +1 (801) 585-0401
Email: kristyn.packer@hsc.utah.edu
-
Enrolling
Virginia
Children's Hospital of The King's Daughters, Norfolk, VA 23507
Contact
Phone: +1
Email:
-
Enrolling
Wisconsin
Children's Hospital of Wisconsin, Milwaukee, WI 53226
Contact
Laura Roth
Phone: +1 (414) 266-3856
Email: lroth@mcw.edu
Email a research coordinator to express interest in participating in this study.
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 a more comprehensive list of eligibility criteria and details on this study, 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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