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

NCT03670303 | Completed DMC

• 1 other identifier: IIRS-IUISB/1602-PHD-005
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 8

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.

Conditions

Refractive Errors; Visual Impairment

Outcome Measures

Primary Outcomes (1)

• Purchase of Spectacles

  Observed wear or possession of purchased glasses.

  3 months follow-up after baseline visit.

Secondary Outcomes (1)

• Wear of spectacles

  6months and one year follow-up after baseline visit.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Educational intervention BEHAVIORAL

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: 1. Lectures on importance of spectacles use including visual materials such as pictures and videos. 2. 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. 3. Posters 4. Brochures

Intervention group

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Isra University: lead

Study Sites (8)

Islamabad Model School for Boys G-11/2

Islamabad, 46000, Pakistan

Location

Islamabad Model School for Boys I-10/2

Islamabad, 46000, Pakistan

Location

Islamabad Model School for Boys I-8/4

Islamabad, 46000, Pakistan

Location

Islamabad Model School for Boys I-9/4

Islamabad, 46000, Pakistan

Location

Islamabad Model School for Girls 1-10/4

Islamabad, 46000, Pakistan

Location

Islamabad Model School for Girls F-6/1

Islamabad, 46000, Pakistan

Location

Islamabad Model School for Girls F-7/2

Islamabad, 46000, Pakistan

Location

Islamabad Model School for Girls G-7/1

Islamabad, 46000, Pakistan

Location

MeSH Terms

Conditions

Refractive Errors; Vision Disorders

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Shaista Habibullah, PhD

  Director (Tech)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD Scholar

Model Details: 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 Record Dates

• First Submitted: September 12, 2018
• First Posted: September 13, 2018
• Study Start: September 27, 2018
• Primary Completion: March 8, 2019
• Study Completion: February 12, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

PA (8)