Health Outcomes of Parents With Cystic Fibrosis-Aim 2

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh

About this trial

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

Qualifiers

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

Disqualifiers

Undergone a lung transplant

Does not speak/read English or Spanish

Trial design

Treatments tested in this trial

  • Parenthood

Treatment groups

No treatment groups listed

Sponsors and collaborators

University of Pittsburgh

Lead sponsor

Cystic Fibrosis Foundation

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator