Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-28 @ 5:44 AM
Study NCT ID:
NCT00602056
Status:
COMPLETED
Last Update Posted:
2008-01-28
First Post:
2008-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017028', 'term': 'Caregivers'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1506}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-13', 'studyFirstSubmitDate': '2008-01-13', 'studyFirstSubmitQcDate': '2008-01-13', 'lastUpdatePostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The study outcome in each study group was the immunization status categorized into "DPT3 completed" and "DPT3 not completed".', 'timeFrame': '90 day follow-up after enrollment at DPT1 visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Immunization dropout', 'Immunization card', 'Center based education'], 'conditions': ['Childhood Immunization Completion', 'Childhood Immunization Dropout', 'Immunization Card', 'Center Based Education']}, 'descriptionModule': {'briefSummary': 'The objective of the study was to assess the effect of 1) redesigned immunization card, 2) center-based education to mothers, and 3) redesigned card with center-based education to mothers, provided at DPT1, on DPT3 completion in a randomized controlled trial at rural Expanded Programme on Immunization (EPI) centers in Karachi, Pakistan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '365 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children visiting the selected EPI centers for DPT1 immunization\n\nExclusion Criteria:\n\n* Not residing in the same area for last six months.'}, 'identificationModule': {'nctId': 'NCT00602056', 'briefTitle': 'Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'A Randomized Controlled Trial of Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule in a Low Literacy Population in Pakistan', 'orgStudyIdInfo': {'id': 'X050713007'}, 'secondaryIdInfos': [{'id': 'X050713007'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Redesigned immunization card', 'interventionNames': ['Other: Redesigned immunization card']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Center based education to mothers/caregivers', 'interventionNames': ['Other: Center based education to mothers/caregivers']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Redesigned immunization card with center based education to mothers/caregivers', 'interventionNames': ['Other: Redesigned immunization card with center based education to mother/caregivers']}, {'type': 'NO_INTERVENTION', 'label': '4', 'description': 'Standard care only'}], 'interventions': [{'name': 'Redesigned immunization card', 'type': 'OTHER', 'description': 'A low cost nad simplified redesigned immunization card', 'armGroupLabels': ['1']}, {'name': 'Center based education to mothers/caregivers', 'type': 'OTHER', 'description': 'A 2-3 minute center based education to mothers/caregivers', 'armGroupLabels': ['2']}, {'name': 'Redesigned immunization card with center based education to mother/caregivers', 'type': 'OTHER', 'description': 'Redesigned immunization card with center based education to mother/caregivers', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'EPI immunization centers', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Hussain R Usman, MBBS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Hussain R. Usman/Doctoral Trainee', 'oldOrganization': 'University of Alabama at Bormingham'}}}}