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Qualitative Understanding of Experiences With the SIMPLIFY Trial

NCT04320381 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 115

Last updated 2023-08-25

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

Qualitative Interview

2 Semi-Structured Qualitative Interviews

Sponsors & Collaborators

Principal Investigators

  • Gregory Sawicki, MD, MPH · Boston Children's Hospital

  • Kristin Riekert, PhD · Johns Hopkins University

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2022-09-16
Completion
2022-09-16

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04320381 on ClinicalTrials.gov