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Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan

Primary Purpose

Refractive Errors, Visual Impairment

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
Isra University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Refractive Errors

Eligibility Criteria

11 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Islamabad Model School for Boys G-11/2
  • Islamabad Model School for Boys I-10/2
  • Islamabad Model School for Boys I-8/4
  • Islamabad Model School for Boys I-9/4
  • Islamabad Model School for Girls 1-10/4
  • Islamabad Model School for Girls F-6/1
  • Islamabad Model School for Girls F-7/2
  • Islamabad Model School for Girls G-7/1

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Purchase of Spectacles
Observed wear or possession of purchased glasses.

Secondary Outcome Measures

Wear of spectacles
Observed wear of spectacles

Full Information

First Posted
September 12, 2018
Last Updated
September 1, 2021
Sponsor
Isra University
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1. Study Identification

Unique Protocol Identification Number
NCT03670303
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 27, 2018 (Actual)
Primary Completion Date
March 8, 2019 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isra University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors, Visual Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Educational intervention
Intervention 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: Lectures on importance of spectacles use including visual materials such as pictures and videos. 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. Posters Brochures
Primary Outcome Measure Information:
Title
Purchase of Spectacles
Description
Observed wear or possession of purchased glasses.
Time Frame
3 months follow-up after baseline visit.
Secondary Outcome Measure Information:
Title
Wear of spectacles
Description
Observed wear of spectacles
Time Frame
6months and one year follow-up after baseline visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- 1- Children from 6th to 9th grade (approximate age, 11-16 years) of secondary schools in Islamabad. Exclusion Criteria: Children from 10th grade which is the final grade of secondary schools. Children with eye disorders other than refractive error.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaista Habibullah, PhD
Organizational Affiliation
Director (Tech)
Official's Role
Study Director
Facility Information:
Facility Name
Islamabad Model School for Boys G-11/2
City
Islamabad
ZIP/Postal Code
46000
Country
Pakistan
Facility Name
Islamabad Model School for Boys I-10/2
City
Islamabad
ZIP/Postal Code
46000
Country
Pakistan
Facility Name
Islamabad Model School for Boys I-8/4
City
Islamabad
ZIP/Postal Code
46000
Country
Pakistan
Facility Name
Islamabad Model School for Boys I-9/4
City
Islamabad
ZIP/Postal Code
46000
Country
Pakistan
Facility Name
Islamabad Model School for Girls 1-10/4
City
Islamabad
ZIP/Postal Code
46000
Country
Pakistan
Facility Name
Islamabad Model School for Girls F-6/1
City
Islamabad
ZIP/Postal Code
46000
Country
Pakistan
Facility Name
Islamabad Model School for Girls F-7/2
City
Islamabad
ZIP/Postal Code
46000
Country
Pakistan
Facility Name
Islamabad Model School for Girls G-7/1
City
Islamabad
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan

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