protocolSection identificationModule nctId: NCT06296394, orgStudyIdInfo id: STUDY23080161, secondaryIdInfos id: 1R01HL161164-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01HL161164-01A1, secondaryIdInfos id: KAZMER22A0, type: OTHER_GRANT, domain: Cystic Fibrosis Foundation, briefTitle: Health Outcomes of Parents With Cystic Fibrosis-Aim 2, acronym: HOPeCF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2030-02-01, completionDateStruct date: 2031-02-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, collaborators name: Cystic Fibrosis Foundation, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: 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/stressH3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulatorsParticipants 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., conditionsModule conditions: Cystic Fibrosis, conditions: Parenthood Status, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 146, type: ESTIMATED, armsInterventionsModule interventions name: Parenthood, outcomesModule primaryOutcomes measure: Forced Expiratory Volume (FEV1), secondaryOutcomes measure: Pulmonary Function Tests (PFTs) - Forced Vital Capacity (FVC), secondaryOutcomes measure: Pulmonary Function Tests (PFTs) - Forced Expiratory Volume (FEV1), secondaryOutcomes measure: Pulmonary Function Tests (PFTs) - Forced Expiratory Flow at 25 and 75 percent (FEF25-75), secondaryOutcomes measure: History of CF Diagnosis, secondaryOutcomes measure: History of CF Genotype Information, secondaryOutcomes measure: History of CF Mutation, secondaryOutcomes measure: Number of Hospitalizations, secondaryOutcomes measure: Length of Hospitalizations, secondaryOutcomes measure: Number of Pulmonary Exacerbations, secondaryOutcomes measure: Severity of Pulmonary Exacerbations, secondaryOutcomes measure: Treatment of Pulmonary Exacerbations, secondaryOutcomes measure: Rate of Hospitalizations Due to Pulmonary Exacerbations, secondaryOutcomes measure: Clinic Visit Attendance, secondaryOutcomes measure: Microbiologic Profile, secondaryOutcomes measure: Medication use, secondaryOutcomes measure: History of CF-Related Diabetes Status, secondaryOutcomes measure: CF-Related Diabetes Control - Hemoglobin A1C, secondaryOutcomes measure: CF-Related Diabetes Control - Glucose Tolerance, secondaryOutcomes measure: CF-Related Diabetes Control - Insulin Prescription Usage, secondaryOutcomes measure: Liver Disease Status, secondaryOutcomes measure: Transplantation Status, secondaryOutcomes measure: Transplantation Type, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Parental Stress, secondaryOutcomes measure: Life Stressors, secondaryOutcomes measure: Cystic Fibrosis Questionnaire to evaluate quality of life domains, secondaryOutcomes measure: Parental Responsibility, secondaryOutcomes measure: Daily Care Check-In, secondaryOutcomes measure: Social Support, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Self-Reported Adherence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama-Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: George M Solomon, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: National Jewish Health, city: Denver, state: Colorado, zip: 80206, country: United States, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Northwestern University, city: Evanston, state: Illinois, zip: 60208, country: United States, contacts name: Manu Jain, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.04114, lon: -87.69006, locations facility: Indiana University, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: Cynthia Brown, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76838, lon: -86.15804, locations facility: University of Kansas Medical Center, city: Kansas City, state: Kansas, zip: 66160, country: United States, contacts name: Megan Behrman, role: CONTACT, email: mbehrman@kumc.edu, contacts name: Amanda Bruce, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.11417, lon: -94.62746, locations facility: Johns Hopkins University, city: Baltimore, state: Maryland, zip: 21218, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Boston Children's Hospital/Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Jonathan Greenberg, role: CONTACT, email: jonathan.greenberg@childrens.harvard.edu, contacts name: Manuela Cernadas, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Shijing Jia, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, locations facility: University of Minnesota, city: Minneapolis, state: Minnesota, zip: 55455, country: United States, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Washington University School of Medicine, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Daniel Rosenbluth, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: University of North Carolina, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Oregon Health and Science University, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Aaron Trimble, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Denis Hadjiliadis, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: University of Pittsburgh, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Medical University of South Carolina, city: Charleston, state: South Carolina, zip: 29425, country: United States, contacts name: Patrick Flume, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.77657, lon: -79.93092, locations facility: University of Texas-Southwestern, city: Dallas, state: Texas, zip: 75390, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: University of Washington, city: Seattle, state: Washington, zip: 98195, country: United States, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False