Clinical trial NCT05829694: Health Outcomes of Parents With Cystic Fibrosis
Official title: Health Outcomes of Parents With Cystic Fibrosis (HOPeCF): A Retrospective Analysis of Impact of Parenthood on Lung Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Parenthood Status
Keywords: cystic fibrosis
parenthood
highly-effective modulator therapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-04-26
Enrollment: 956
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with cystic fibrosis who are participants in the Cystic Fibrosis Foundation's Patient Registry.

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.

Eligibility criteria: 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

Primary outcomes:
measure: FEV1
timeFrame: 2012-2022
Secondary outcomes:
measure: Rate of pulmonary exacerbations
timeFrame: 2012-2022
measure: Rate of hospitalizations
timeFrame: 2012-2022
measure: Clinic visit attendance
timeFrame: 2012-2022
measure: BMI
timeFrame: 2012-2022
measure: Medication Use
timeFrame: 2012-2022
measure: CFRD Control
timeFrame: 2012-2022
measure: Microbiologic profile
timeFrame: 2012-2022
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas-Southwestern
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Pittsburgh
name: Traci M Kazmerski, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: