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Health Outcomes of Parents With Cystic Fibrosis-Aim 2

RecruitingObservational study

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: University of Pittsburgh · Participants: 146 · Started: May 29, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06296394

Locations in the U.S.

AlabamaUniversity of Alabama-Birmingham, Birmingham
ColoradoNational Jewish Health, Denver
IllinoisNorthwestern University, Evanston (Not yet recruiting)
IndianaIndiana University, Indianapolis
KansasUniversity of Kansas Medical Center, Kansas City
MarylandJohns Hopkins University, Baltimore
MassachusettsBoston Children's Hospital/Brigham and Women's Hospital, Boston
Massachusetts General Hospital, Boston
MichiganUniversity of Michigan, Ann Arbor
MinnesotaUniversity of Minnesota, Minneapolis
MissouriWashington University School of Medicine, St Louis
North CarolinaUniversity of North Carolina, Chapel Hill
OregonOregon Health and Science University, Portland
PennsylvaniaUniversity of Pennsylvania, Philadelphia
University of Pittsburgh, Pittsburgh
South CarolinaMedical University of South Carolina, Charleston
TexasUniversity of Texas-Southwestern, Dallas
WashingtonUniversity of Washington, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.