NCT06296394 Health Outcomes of Parents With Cystic Fibrosis-Aim 2
| NCT ID | NCT06296394 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Cystic Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 146 participants |
| Start Date | 2024-05-29 |
| Primary Completion | 2030-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 146 participants in total. It began in 2024-05-29 with a primary completion date of 2030-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with cystic fibrosis via sweat test or genotype analysis * Became a first-time parent (including foster parent, step parent, adoptive parent, or legal guardian) to a child under 5 years of age within the last 180 days Exclusion Criteria: * Undergone a lung transplant * Does not speak/read English or Spanish
Contact & Investigator
Traci M Kazmerski, MD
PRINCIPAL INVESTIGATOR
Faculty
Frequently Asked Questions
Who can join the NCT06296394 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06296394 currently recruiting?
Yes, NCT06296394 is actively recruiting participants. Contact the research team at stranskyom@upmc.edu for enrollment information.
Where is the NCT06296394 trial being conducted?
This trial is being conducted at Birmingham, United States, Denver, United States, Evanston, United States, Indianapolis, United States and 11 additional locations.
Who is sponsoring the NCT06296394 clinical trial?
NCT06296394 is sponsored by University of Pittsburgh. The principal investigator is Traci M Kazmerski, MD at Faculty. The trial plans to enroll 146 participants.