Health Outcomes of Parents With Cystic Fibrosis (HOPeCF): A Retrospective Analysis of Impact of Parenthood on Lung Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Pittsburgh
- Enrollment
- 996
- Locations
- 8
- Primary Endpoint
- FEV1
Study Overview
Brief Summary
This project will determine the health impact of parenthood on people with cystic fibrosis (CF). The study team will use retrospective data to provide relatively immediate evidence on parenthood's effect on pulmonary health.
Detailed Description
This co-funded study sponsored by the National Institutes of Health and the CF Foundation (CFF) will seek to determine the health impact of parenthood on people with CF in the era of CF transmembrane conductance regulator (CFTR) modulators. To provide relatively immediate evidence on parenthood's effect on pulmonary health and the influence of the introduction and use of all available CFTR modulators, in Aim 1 the study team will assess changes in pre- vs. intra-parenthood percent predicted forced expiratory volume in 1 second (ppFEV1) in a retrospective longitudinal cohort study linking CFF patient registry (CFFPR) data with cross-sectional surveys collected from 249 new parents attending participating United States CF centers between 2012-2022. The study team will identify predictors and timing of lung function loss using 747 non-parents from participating centers as a comparison group and examine the impact of CFTR modulators on parental health.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed CF diagnosis with sweat or genotype analysis
- •Participant in the CFFPR
- •Became a first-time parent between the years 2012-2022 (exposure arm only)
Exclusion Criteria
- •Lung transplant prior to becoming a first-time parent (exposure arm) or prior to study period (control)
- •Does not speak/read English or Spanish
Outcomes
Primary Outcomes
FEV1
Time Frame: 2012-2022
Rate of decline of ppFEV1 as reported in the CFFPR
Secondary Outcomes
- Clinic visit attendance(2012-2022)
- BMI(2012-2022)
- Rate of pulmonary exacerbations(2012-2022)
- Medication Use(2012-2022)
- CFRD Control(2012-2022)
- Rate of hospitalizations(2012-2022)
- Microbiologic profile(2012-2022)
Investigators
Traci Kazmerski
Assistant Professor of Pediatrics
University of Pittsburgh