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NCT06296394 · ClinicalTrials.gov registry record
Health Outcomes of Parents With Cystic Fibrosis-Aim 2
A clinical trial of Cystic Fibrosis and Parenthood Status, sponsored by University of Pittsburgh.
- Recruiting
- Registry status
- 146
- Enrollment target
- 18
- Study locations
NCT06296394: Recruiting study of Cystic Fibrosis and Parenthood Status, sponsored by University of Pittsburgh.
NCT06296394 is a study of Cystic Fibrosis and Parenthood Status that is actively recruiting participants, run by University of Pittsburgh. The registered enrollment target is 146 participants, below the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (18% lower). The trial reports 18 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06296394, a study of Cystic Fibrosis and Parenthood Status, is actively recruiting participants, sponsored by University of Pittsburgh.
- RECRUITING
- Registry status
- 146 participants
- Enrollment target
- 18
- Study locations
Study Summary
The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the impact of parenthood in CF with widespread highly effective CFTR modulator use. The main hypotheses this study aims to examine are: H1: Parents with CF and moderate-to-severe depression have more rapid change in ppFEV1 (percent predicted forced expiratory volume in one second) versus those with mild or no depression. H2: Parents with CF who have more parental responsibility and/or stress have more rapid ppFEV1 (percent predicted forced expiratory volume in one second) change than those with less responsibility/stress H3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulators Participants will complete quarterly surveys during the first year of parenthood and biannual surveys, thereafter, using the computer-based survey system on an iPad protected for infection control or via personal device or computer via emailed survey link.
Primary Outcome
Rate of change in ppFEV1 as reflected in the medical record from Year 1 to Year 5
Conditions Studied
Interventions
- OTHER Parenthood
Study Locations (18)
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Children's Hospital/Brigham and Women's Hospital - Boston
Pennsylvania
- University of Pennsylvania - Philadelphia
- University of Pittsburgh - Pittsburgh
Alabama
- University of Alabama-Birmingham - Birmingham
Colorado
- National Jewish Health - Denver
Illinois
- Northwestern University - Evanston
Indiana
- Indiana University - Indianapolis
Kansas
- University of Kansas Medical Center - Kansas City
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2024-05-29 |
| Est. Completion | 2031-02-01 |
What NCT06296394 shows while recruiting
NCT06296394 is an observational study that tracks outcomes without assigning an intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, below the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (18% lower).
The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Parenthood is the first listed.
NCT06296394 lists 18 locations in 16 states (Massachusetts, Pennsylvania, Alabama).
Frequently Asked Questions
What is clinical trial NCT06296394 about?
NCT06296394 is a clinical study titled "Health Outcomes of Parents With Cystic Fibrosis-Aim 2". The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the imp...
What is the current status of trial NCT06296394?
This trial is currently recruiting. The enrollment target is 146 participants. The study started on 2024-05-29. Estimated completion is 2031-02-01.
What conditions does trial NCT06296394 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Parenthood Status.
What interventions are being tested in trial NCT06296394?
The interventions under investigation include: Parenthood (OTHER).
Who is sponsoring clinical trial NCT06296394?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06296394 being conducted?
This trial has 18 study locations across Alabama, Colorado, Illinois, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06296394's enrollment target sits among peer trials
146 46th of 169 higher than 124 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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