Health Outcomes of Parents With Cystic Fibrosis-Aim 2

Recruiting now

Conditions studied: Cystic Fibrosis, Parenthood Status

In brief

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.

Key facts

Study ID

NCT06296394

Run by

University of Pittsburgh

People needed

146

Starts

2024-05-29

Expected to finish

2031-02-01

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Undergone a lung transplant
• Does not speak/read English or Spanish

Where it is running

• University of Washington — Seattle, Washington, United States (enrolling)
• National Jewish Health — Denver, Colorado, United States (enrolling)
• University of Alabama-Birmingham — Birmingham, Alabama, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Boston Children's Hospital/Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• University of Texas-Southwestern — Dallas, Texas, United States (enrolling)
• Northwestern University — Evanston, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.