Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 8:24 AM
Study NCT ID:
NCT07069192
Status:
COMPLETED
Last Update Posted:
2025-07-20
First Post:
2025-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Invisible Trigger: A Quasi-Experimental Study on the Effect of Passive Smoke Exposure and Counselling Intervention in Childhood Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The primary purpose is to offer practical insights into reducing the burden of childhood asthma by fusing exposure reduction techniques with asthma management education. It is anticipated that the results will guide evidence-based policy and public health campaigns to lower exposure to SHS, improve asthma outcomes, and improve the lives of children with the condition.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-07-07', 'studyFirstSubmitQcDate': '2025-07-07', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma control test (ACT) Score Improvement', 'timeFrame': '3 months', 'description': 'Change in ACT Score from baseline to 3 months after intervention. ACT score of 19 is considered as normal Asthma control, less then 19 is considered as poor Asthma control and more than 19 ACT score is considered as good Asthma control'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma.', 'Passive Smoke Exposure,', 'Secondhand Smoke,', 'Counsel Intervention,', 'Childhood Asthma,', 'Asthma Control Test,', 'Caregiver Education'], 'conditions': ['Childhood Asthma', 'Passive Smoke Exposure']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of passive smoke exposure on childhood asthma and the role of structured counseling in reducing SHS exposure and improving asthma control.', 'detailedDescription': 'A quasi-experimental study conducted at Fauji Foundation Hospital using a pre-post test design. The intervention group received structured caregiver counseling about the dangers of passive smoking and asthma management. The study used ACT scores to assess improvement in asthma control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed Asthma, Passive smoke exposure\n\nExclusion Criteria:\n\n* Comorbidity, sever asthma requiring hospitalisation'}, 'identificationModule': {'nctId': 'NCT07069192', 'acronym': 'Asthma', 'briefTitle': 'The Invisible Trigger: A Quasi-Experimental Study on the Effect of Passive Smoke Exposure and Counselling Intervention in Childhood Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Foundation University Islamabad'}, 'officialTitle': 'The Effect of Passive Smoke Exposure and Counselling Intervention in Childhood Asthma', 'orgStudyIdInfo': {'id': 'FUMCRCT1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'usual care without counselling'}, {'type': 'EXPERIMENTAL', 'label': 'Counselling', 'description': 'Counselling', 'interventionNames': ['Behavioral: Counselling']}], 'interventions': [{'name': 'Counselling', 'type': 'BEHAVIORAL', 'description': 'Received structured caregiver counseling - weekly sessions for 1 month and biweekly for the next 2 months.', 'armGroupLabels': ['Counselling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Fauji Foundation Hospital, Rawalpindi', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not Required'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation University Islamabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Public health Officer', 'investigatorFullName': 'Ayesha Saeed', 'investigatorAffiliation': 'Foundation University Islamabad'}}}}