Health Outcomes of Parents With Cystic Fibrosis-Aim 2

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama-Birmingham
RECRUITING
Birmingham
Colorado
National Jewish Health
RECRUITING
Denver
Illinois
Northwestern University
NOT_YET_RECRUITING
Evanston
Indiana
Indiana University
RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Boston Children's Hospital/Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Oregon
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
University of Pittsburgh
RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
University of Texas-Southwestern
RECRUITING
Dallas
Washington
University of Washington
RECRUITING
Seattle
Contact Information
Primary
Olivia M Stransky, MPH
stranskyom@upmc.edu
412-648-4701
Time Frame
Start Date: 2024-05-29
Estimated Completion Date: 2031-02-01
Participants
Target number of participants: 146
Related Therapeutic Areas
Sponsors
Leads: University of Pittsburgh
Collaborators: Cystic Fibrosis Foundation, National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov