Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-25 @ 2:40 PM
Study NCT ID:
NCT07283250
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-19
First Post:
2025-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Validation of the Air Quality Awareness Scale (AQAS) for Parents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of Parental Knowledge and Awareness About Air Quality', 'timeFrame': 'At baseline (single survey administration)', 'description': "The primary outcome is the overall score obtained from the Air Quality Knowledge and Behavior Questionnaire, reflecting parents' knowledge and awareness regarding air quality and air pollution.\n\nThe composite score will be derived from the 5 knowledge and 10 awareness items, each rated on a Likert scale (e.g., 1 = strongly disagree to 5 = strongly agree).\n\nHigher total scores indicate greater knowledge and awareness of air pollution, its sources, and its health effects."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma (Diagnosis)', 'Air Quality', 'Air Pollution', 'Rhinitis, Allergic', 'Health Knowledge, Attitudes, Practice', 'Health Belief Model', 'Parents']}, 'descriptionModule': {'briefSummary': "This cross-sectional study aims to assess the level of awareness, knowledge, and preventive behaviors regarding air quality and air pollution among parents of children with physician-diagnosed allergic respiratory diseases (asthma and/or allergic rhinitis). The survey will evaluate parents' understanding of air pollution effects, sources, and protective measures, as well as sociodemographic and clinical correlates influencing awareness."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of parents or primary caregivers of children aged 2 to 18 years who have been clinically diagnosed with allergic airway diseases, specifically asthma and/or allergic rhinitis, by a pediatric allergy specialist.\n\nParticipants will be recruited from the outpatient Pediatric Allergy Clinic of a tertiary healthcare center.\n\nAll participants must be able to read and understand Turkish and voluntarily provide written informed consent.\n\nThe survey targets approximately 500 parents, representing diverse educational and socioeconomic backgrounds, to evaluate knowledge, awareness, and behaviors related to air quality and pollution.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent or primary caregiver of a child aged 2-18 years\n* Child has a physician-diagnosed asthma and/or allergic rhinitis\n* Able to read and understand Turkish\n* Provides informed consent\n\nExclusion Criteria:\n\n* Parents of children with other chronic respiratory or systemic diseases\n* Parents who are healthcare professionals (to avoid bias)\n* Incomplete survey responses'}, 'identificationModule': {'nctId': 'NCT07283250', 'briefTitle': 'Development and Validation of the Air Quality Awareness Scale (AQAS) for Parents', 'organization': {'class': 'OTHER', 'fullName': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}, 'officialTitle': 'Development and Validation of the Air Quality Awareness Scale (AQAS) for Parents of Children With Allergic Diseases: A Cross-sectional Study', 'orgStudyIdInfo': {'id': '2025-654789651231'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parents of Children with Allergic Airway Diseases', 'description': 'This cohort includes parents or primary caregivers of children aged 2-18 years who have been clinically diagnosed with allergic airway diseases (asthma and/or allergic rhinitis) by a pediatric allergy specialist. Participants will complete a structured questionnaire assessing their awareness, knowledge, and preventive behaviors regarding air pollution and air quality.', 'interventionNames': ['Behavioral: Air Quality Knowledge Questionnaire']}], 'interventions': [{'name': 'Air Quality Knowledge Questionnaire', 'type': 'BEHAVIORAL', 'description': "A structured, self-administered questionnaire on air quality and pollution will be provided to all participants.\n\nThe survey consists of a total of 23 main items and an additional demographic information section.\n\nThe demographic section collects data on parent's age, gender, education level, occupation, and the child's age, gender, diagnosis (asthma and/or allergic rhinitis), and disease duration.\n\nThe main questionnaire includes:\n\n* 5 items assessing knowledge of air pollution and air quality concepts;\n* 10 items measuring awareness of air pollution sources, health impacts, and environmental conditions;\n* 8 items evaluating attitudes and protective behaviors toward air pollution (e.g., monitoring air quality index, modifying outdoor activities, using indoor air filters).\n\nResponses are based on a Likert-type scale. The tool is designed to quantify parental understanding, awareness, and preventive practices related to air quality in the context of childhood allergic airway diseases.", 'armGroupLabels': ['Parents of Children with Allergic Airway Diseases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34384', 'city': 'Istanbul', 'state': 'Şişli', 'country': 'Turkey (Türkiye)', 'facility': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared publicly because the dataset contains potentially identifiable information collected from a limited number of participants at a single center.\n\nOnly aggregated, de-identified summary data will be included in publications and presentations.\n\nThe study protocol and statistical analysis plan may be shared upon reasonable request from qualified researchers, following approval by the principal investigator and the institutional ethics committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Pediatric Immunology and Allergy', 'investigatorFullName': 'Hilal Gungor', 'investigatorAffiliation': 'Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization'}}}}