Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 5:31 AM
Study NCT ID:
NCT05829694
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Outcomes of Parents With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 956}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2023-03-08', 'studyFirstSubmitQcDate': '2023-04-24', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1', 'timeFrame': '2012-2022', 'description': 'Rate of decline of ppFEV1 as reported in the CFFPR'}], 'secondaryOutcomes': [{'measure': 'Rate of pulmonary exacerbations', 'timeFrame': '2012-2022', 'description': 'Rate of pulmonary exacerbations as reported in the CFFPR'}, {'measure': 'Rate of hospitalizations', 'timeFrame': '2012-2022', 'description': 'Rate of hospitalizations as reported in the CFFPR'}, {'measure': 'Clinic visit attendance', 'timeFrame': '2012-2022', 'description': 'Clinic visit attendance as reported in the CFFPR'}, {'measure': 'BMI', 'timeFrame': '2012-2022', 'description': 'BMI as reported in the CFFPR'}, {'measure': 'Medication Use', 'timeFrame': '2012-2022', 'description': 'Medication use as reported in the CFFPR'}, {'measure': 'CFRD Control', 'timeFrame': '2012-2022', 'description': 'HbgA1c as reported in the CFFPR'}, {'measure': 'Microbiologic profile', 'timeFrame': '2012-2022', 'description': 'Presence of specific types of bacteria, mycobacteria, fungus in cultures as reported in the CFFPR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cystic fibrosis', 'parenthood', 'highly-effective modulator therapy'], 'conditions': ['Cystic Fibrosis', 'Parenthood Status']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Individuals with cystic fibrosis who are participants in the Cystic Fibrosis Foundation's Patient Registry.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed CF diagnosis with sweat or genotype analysis\n* Participant in the CFFPR\n* Became a first-time parent between the years 2012-2022 (exposure arm only)\n\nExclusion Criteria:\n\n* Lung transplant prior to becoming a first-time parent (exposure arm) or prior to study period (control)\n* Does not speak/read English or Spanish'}, 'identificationModule': {'nctId': 'NCT05829694', 'acronym': 'HOPeCF', 'briefTitle': 'Health Outcomes of Parents With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Health Outcomes of Parents With Cystic Fibrosis (HOPeCF): A Retrospective Analysis of Impact of Parenthood on Lung Function', 'orgStudyIdInfo': {'id': 'STUDY22010135'}, 'secondaryIdInfos': [{'id': '1R01HL161164-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL161164-01A1', 'type': 'NIH'}, {'id': 'KAZMER22A0', 'type': 'OTHER_GRANT', 'domain': 'Cystic Fibrosis Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parents', 'description': 'Individuals diagnosed with cystic fibrosis who became a first-time parent between January 1, 2012 and December 31, 2022.', 'interventionNames': ['Other: Parental Status']}, {'label': 'Non-parents', 'description': 'Individuals diagnosed with cystic fibrosis who have never been a parent.'}], 'interventions': [{'name': 'Parental Status', 'type': 'OTHER', 'description': 'The aim of the study is to assess the impact parenthood has on health outcomes.', 'armGroupLabels': ['Parents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas-Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Traci M Kazmerski, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cystic Fibrosis Foundation', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Traci Kazmerski', 'investigatorAffiliation': 'University of Pittsburgh'}}}}