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NCT04320381 · ClinicalTrials.gov registry record
Qualitative Understanding of Experiences With the SIMPLIFY Trial
A clinical trial, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- 115
- Enrollment target
NCT04320381: Completed study, sponsored by Boston Children's Hospital.
NCT04320381 is a clinical trial that has completed, run by Boston Children's Hospital. The registered enrollment target is 115 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04320381 has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- 115 participants
- Enrollment target
Study 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 triple combination CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) modulator therapy (TCT). Cohorts will be determined based on sub-groups of the assigned treatment arms from the SIMPLIFY study. Participants will be asked to participate in two interviews; the first interview will be conducted at the completion of the SIMPLIFY study and the second interview will be conducted approximately 4 months after the first interview. Trained research staff will conduct the semi-structured interviews that will be audio-recorded and transcribed for thematic analysis. Each interview should last between 30-60 minutes.
Primary Outcome
Questions to evaluate (A) attitudes and beliefs regarding participation in a withdrawal study and (B) perceptions of treatment burden in the context of having participated in a withdrawal study.
Interventions
- BEHAVIORAL Qualitative Interview
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2020-12-23 |
| Est. Completion | 2022-09-16 |
What the finished NCT04320381 record still lists
NCT04320381 is an observational study that tracks outcomes without assigning an intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Qualitative Interview is the first listed.
NCT04320381 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04320381 about?
NCT04320381 is a clinical study titled "Qualitative Understanding of Experiences With the SIMPLIFY Trial". 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 triple combination CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) modulator therapy (TCT). C...
What is the current status of trial NCT04320381?
This trial is currently completed. The enrollment target is 115 participants. The study started on 2020-12-23. Estimated completion is 2022-09-16.
What interventions are being tested in trial NCT04320381?
The interventions under investigation include: Qualitative Interview (BEHAVIORAL).
Who is sponsoring clinical trial NCT04320381?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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