Status:
COMPLETED
Qualitative Understanding of Experiences With the SIMPLIFY Trial
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Cystic Fibrosis
Drug Withdrawal
Eligibility:
All Genders
14+ years
Brief Summary
This qualitative longitudinal study is designed to elicit and thematically analyze the perspectives of SIMPLIFY subjects about treatment withdrawal research and treatment burden in the context of trip...
Detailed Description
The recommended daily treatment regimen for CF is complex and results in high treatment burden for many people with CF (PwCF). Newly developed triple combination CFTR modulator therapy (TCT) has shown...
Eligibility Criteria
Inclusion
- Patient Participant:
- Participant was randomized into the SIMPLIFY study
- Person with CF is ≥ 14 years of age at the time of randomization into SIMPLIFY
- Is English speaking
- Participant has provided consent (or assent if applicable) in the SIMPLIFY study to provide contact information and share data from the SIMPLIFY study with the QUEST study team
- Participant has provided contact information via the QUEST portal
- Is willing and able to adhere to the study requirements
- Provides consent (or assent if applicable) for the QUEST study
- Completed participation in the SIMPLIFY study (i.e. completed through Visit 3 or early withdrawal, if applicable)
- Caregiver Participant:
- Lives in the same household as a child with CF who is ≥ 14 years of age but \<18 years of age who meets the eligibility requirements for the QUEST study
- Is English speaking,
- Is willing and able to adhere to the study requirements
- Provides consent for the QUEST study
Exclusion
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 1\. Any situation that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data
Key Trial Info
Start Date :
December 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 16 2022
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04320381
Start Date
December 23 2020
End Date
September 16 2022
Last Update
August 25 2023
Active Locations (2)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115