RecruitingNCT06296394

Health Outcomes of Parents With Cystic Fibrosis-Aim 2


Sponsor

University of Pittsburgh

Enrollment

146 participants

Start Date

May 29, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria2

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERParenthood

The intervention group will consist of participants who became first time parents to children under 5 years of age.


Locations(18)

University of Alabama-Birmingham

Birmingham, Alabama, United States

National Jewish Health

Denver, Colorado, United States

Northwestern University

Evanston, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Children's Hospital/Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas-Southwestern

Dallas, Texas, United States

University of Washington

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06296394


Related Trials