Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT03670303
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2018-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'It is limitation of study that at base line data collection and data analysis masking is not possible as investigator has to do herself. Only outcome assessor can be masked to see how many students are using spectacles in intervention group and in control group. he will not be aware about type of groups.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study will involve two groups intervention group and no intervention (control) group. each group will include two boys and two girls schools. Educational intervention will be given to two boys and two girls schools. Remaining two boys and two girls schools will not receive educational intervention. Simultaneous follow-ups will be carried out in two groups to assess compliance towards spectacles use.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-01', 'studyFirstSubmitDate': '2018-09-12', 'studyFirstSubmitQcDate': '2018-09-12', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Purchase of Spectacles', 'timeFrame': '3 months follow-up after baseline visit.', 'description': 'Observed wear or possession of purchased glasses.'}], 'secondaryOutcomes': [{'measure': 'Wear of spectacles', 'timeFrame': '6months and one year follow-up after baseline visit.', 'description': 'Observed wear of spectacles'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractive Errors', 'Visual Impairment']}, 'descriptionModule': {'briefSummary': 'This study is planned to test an educational intervention promoting the use of spectacles among secondary school children. It is based on the hypothesis that educating teachers, parents and children about the importance of wearing spectacles has the potential to increase spectacle wear among children.Reasons for non-compliance towards spectacle use will be explored and educational intervention will be planned considering these reasons. Educational intervention will increase awareness about the importance of spectacles use and reduce the barriers towards spectacle use.Reducing barriers will increase compliance towards spectacles use which will ultimately prevent the avoidable visual impairment.', 'detailedDescription': 'Aim of this research is to improve school performance and quality of life of children with refractive errors. Planned research will be carried out in eight (4 girls and 4 boys) Public Sector Secondary Schools of Islamabad and vision of students will be tested with standard snellen chart to recruit 120 boys and 120 girls with refractive errors. Students having vision ≤ 6/12 will receive auto refraction and prescription of spectacles will be given after subjective refraction. primary outcome of purchase of glasses will be asessed at three months after prescribing. Follow up after six months of prescribing spectacles will find out compliance towards spectacles. Non-compliant students will be given a questionnaire to provide the reasons for non-compliance towards spectacles. Focus Group Discussions (FGDs) will be conducted with non-compliant students, their teachers and parents to explore reasons of non compliance.\n\nOn the basis of information obtained from FGDs an educational intervention will be planned for students, their parents and teahers to explain importance of spectacles. Through stratified randomization schools will be assigned to intervention and control groups. Four schools including two girls and two boys schools will be assigned to intervention group and four schools (two girls and two boys) will be assigned to control group. Educational intervention will be given to intervention group. Six months after the intervention compliance to spectacle wear will be assessed than pre and post intervention compliance in intervention group and between two groups will be compared to assess effectiveness of intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:-\n\n1- Children from 6th to 9th grade (approximate age, 11-16 years) of secondary schools in Islamabad.\n\nExclusion Criteria:\n\n1. Children from 10th grade which is the final grade of secondary schools.\n2. Children with eye disorders other than refractive error.'}, 'identificationModule': {'nctId': 'NCT03670303', 'briefTitle': 'Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan', 'organization': {'class': 'OTHER', 'fullName': 'Isra University'}, 'officialTitle': 'Randomized, Controlled Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan', 'orgStudyIdInfo': {'id': 'IIRS-IUISB/1602-PHD-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'This group will include randomly selected two boys and two girls schools. Vision screening and refraction will be carried out at base line.Compliance will be assessed at 6 months follow-up after baseline assessment than educational intervention will be given. Six months after intervention compliance will be assessed again.', 'interventionNames': ['Behavioral: Educational intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'This group will also include randomly selected two boys and two girls schools. Vision screening and refraction will be carried out at base line.Compliance towards spectacle use will be assessed at 6 months after baseline assessment. No intervention will be given in this group. Compliance will be assessed again at the same time when assessed in intervention group 6 months after the intervention.'}], 'interventions': [{'name': 'Educational intervention', 'type': 'BEHAVIORAL', 'description': 'Educational intervention will be given by trained optometrists to participants (requiring spectacles) their parents and teachers. Duration of Intervention will be about one hours and it includes:\n\n1. Lectures on importance of spectacles use including visual materials such as pictures and videos.\n2. An interactive classroom based demonstration carried out by trained optometrist. Children will be asked to read from blackboard, written to be visible with 6/6 vision, while seated at a distance of 6m. After this children will be given their glasses and asked to read again. The purpose of this demonstration is to make children aware of their poor vision and of the potential impact of corrected VA.\n3. Posters\n4. Brochures', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Islamabad Model School for Boys G-11/2', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}, {'zip': '46000', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Islamabad Model School for Boys I-10/2', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}, {'zip': '46000', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Islamabad Model School for Boys I-8/4', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}, {'zip': '46000', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Islamabad Model School for Boys I-9/4', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}, {'zip': '46000', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Islamabad Model School for Girls 1-10/4', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}, {'zip': '46000', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Islamabad Model School for Girls F-6/1', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}, {'zip': '46000', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Islamabad Model School for Girls F-7/2', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}, {'zip': '46000', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Islamabad Model School for Girls G-7/1', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Shaista Habibullah, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director (Tech)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isra University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD Scholar', 'investigatorFullName': 'Nusrat Nasim', 'investigatorAffiliation': 'Isra University'}}}}