Clinical trial NCT03670303: Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan
Official title: Randomized, Controlled Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Visual Impairment
Lead sponsor: Isra University
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 240
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

On 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.

Eligibility criteria: Inclusion Criteria:-

1- Children from 6th to 9th grade (approximate age, 11-16 years) of secondary schools in Islamabad.

Exclusion Criteria:

1. Children from 10th grade which is the final grade of secondary schools.
2. Children with eye disorders other than refractive error.

Primary outcomes:
measure: Purchase of Spectacles
timeFrame: 3 months follow-up after baseline visit.
Secondary outcomes:
measure: Wear of spectacles
timeFrame: 6months and one year follow-up after baseline visit.
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Islamabad Model School for Boys G-11/2
city: Islamabad
country: Pakistan
facility: Islamabad Model School for Boys I-10/2
city: Islamabad
country: Pakistan
facility: Islamabad Model School for Boys I-8/4
city: Islamabad
country: Pakistan
facility: Islamabad Model School for Boys I-9/4
city: Islamabad
country: Pakistan
facility: Islamabad Model School for Girls 1-10/4
city: Islamabad
country: Pakistan
facility: Islamabad Model School for Girls F-6/1
city: Islamabad
country: Pakistan
facility: Islamabad Model School for Girls F-7/2
city: Islamabad
country: Pakistan
facility: Islamabad Model School for Girls G-7/1
Study officials:
affiliation: Director (Tech)
name: Shaista Habibullah, PhD
role: STUDY_DIRECTOR
References: