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

Sponsor
Isra University (Other)
Overall Status
Completed
CT.gov ID
NCT03670303
Collaborator
(none)
240
8
2
16.5
30
1.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Educational intervention
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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:
Single (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.
Primary Purpose:
Prevention
Official Title:
Randomized, Controlled Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan
Actual Study Start Date :
Sep 27, 2018
Actual Primary Completion Date :
Mar 8, 2019
Actual Study Completion Date :
Feb 12, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

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.

Behavioral: Educational intervention
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

No Intervention: Control group

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.

Outcome Measures

Primary Outcome Measures

  1. Purchase of Spectacles [3 months follow-up after baseline visit.]

    Observed wear or possession of purchased glasses.

Secondary Outcome Measures

  1. Wear of spectacles [6months and one year follow-up after baseline visit.]

    Observed wear of spectacles

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Islamabad Model School for Boys G-11/2 Islamabad Pakistan 46000
2 Islamabad Model School for Boys I-10/2 Islamabad Pakistan 46000
3 Islamabad Model School for Boys I-8/4 Islamabad Pakistan 46000
4 Islamabad Model School for Boys I-9/4 Islamabad Pakistan 46000
5 Islamabad Model School for Girls 1-10/4 Islamabad Pakistan 46000
6 Islamabad Model School for Girls F-6/1 Islamabad Pakistan 46000
7 Islamabad Model School for Girls F-7/2 Islamabad Pakistan 46000
8 Islamabad Model School for Girls G-7/1 Islamabad Pakistan 46000

Sponsors and Collaborators

  • Isra University

Investigators

  • Study Director: Shaista Habibullah, PhD, Director (Tech)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nusrat Nasim, PHD Scholar, Isra University
ClinicalTrials.gov Identifier:
NCT03670303
Other Study ID Numbers:
  • IIRS-IUISB/1602-PHD-005
First Posted:
Sep 13, 2018
Last Update Posted:
Sep 5, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021