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
This trial does not accept healthy volunteersQualifiers
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 population
Individuals with cystic fibrosis who have become first-time parents to a child under 5 years of age.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Parenthood
Other interventionThe intervention group will consist of participants who became first time parents to children under 5 years of age.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Forced Expiratory Volume (FEV1)
Rate of change in ppFEV1 as reflected in the medical record from Year 1 to Year 5
Time frame
Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5Secondary outcomes
1
Pulmonary Function Tests (PFTs) - Forced Vital Capacity (FVC)
Occurrence of PFTs at each clinic visit/hospitalization. Measures include FVC (Forced vital capacity), and the percent predicted.
Time frame
Annually from 2 Years prior to enrollment and annually for Year 1 through Year 52
Pulmonary Function Tests (PFTs) - Forced Expiratory Volume (FEV1)
Occurrence of PFTs at each clinic visit/hospitalization. Measures include FEV1(Forced expiratory volume in one second), and the percent predicted.
Time frame
Annually from 2 Years prior to enrollment and annually for Year 1 through Year 53
Pulmonary Function Tests (PFTs) - Forced Expiratory Flow at 25 and 75 percent (FEF25-75)
Occurrence of PFTs at each clinic visit/hospitalization. Measures include FEF25-75 (forced expiratory flow at 25 percent and 75 percent of the pulmonary volume), and the percent predicted for each.
Time frame
Annually from 2 Years prior to enrollment and annually for Year 1 through Year 54
History of CF Diagnosis
Date of diagnosis, as reported in the medical record.
Time frame
Year 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
Cystic Fibrosis Foundation
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov