NCT06616051

Brief Summary

This study tested whether mobile health (mHealth) tools can affect referral uptake among schoolchildren with vision problems.Visual impairment in children often goes untreated in low- and middle-income countries, even when detected during school screenings, because parents do not follow up on referral advice. In this randomized controlled trial, children aged 5-15 years from two government schools in Rawalpindi, Pakistan, were screened for vision problems using a smartphone-based application. Those identified with possible impairment were randomly assigned to one of two groups. The control group received the usual printed referral form, while the intervention group received the printed referral plus automated, multicomponent SMS reminders in the local language. These reminders included health promotion messages, a visual depiction of the child's vision, and practical instructions about how to reach the hospital. The main outcome was the proportion of referred children who attended the hospital within eight weeks. Secondary analysis examined whether referral uptake was linked with child and family characteristics such as age, sex, and parental education. This was a minimal-risk, school-based trial with 80 participants. The study was ethically approved by the Army Medical College Ethics Review Committee (NUMS). Findings are expected to provide new evidence on the usefulness of mobile phone-based reminders for improving eye health care among children in resource-limited settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

October 21, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

2 months

First QC Date

September 22, 2024

Last Update Submit

October 1, 2025

Conditions

Keywords

visual impairmentmhealthrefractive errorreferral reminder

Outcome Measures

Primary Outcomes (1)

  • Proportion of referred children who will attend the hospital within 8 weeks of referral in both groups

    Primary outcome of interest is the proportion of referred children who attend the hospital within eight weeks of referral in both groups. It will be assessed by weekly telephonic follow up of referred children.

    Follow up for 8 weeks on weekly basis after identification of visual impairment

Secondary Outcomes (1)

  • Secondary outcome of interest is the association of hospital attendance with sociodemographic characteristics of referred participants

    1 - 56 day

Study Arms (2)

Intervention arm

EXPERIMENTAL

Parents or guardians in the intervention group will receive a multicomponent SMS reminder in addition to printed referral forms. These reminders will be delivered every Sunday, Tuesday and Thursday for a duration of eight weeks, or until the child attends the hospital. Research team has already developed an automated text message reminder system for this study, taking into account the local context. The content of the messages was designed with input from a panel of public health consultants and research supervisors, drawing on resources from the WHO Health Promotion and Disease Prevention Messages Library \[21\]. Messages will be sent in Urdu, the native language, and will not require a reply. Each message will include four elements: Health promotion message, visual depiction of a child's vision, a customized action plan detailing how to get to the hospital including the location, how much money is needed and what to carry with them.

Other: Multicomponent SMS reminder

Control arm

NO INTERVENTION

Among control arm, the participants screened positive for visual impairment in the control group will receive a referral form. There will be no mHealth referral reminder sent to the identified visual impaired children.

Interventions

SMS reminder will be delivered every Sunday, Tuesday and Thursday for a duration of eight weeks, or until the child attends the hospital. Research team has already developed an automated text message reminder system for this study, taking into account the local context. The messages was designed with input from a panel of public health consultants and research supervisors, drawing on resources from the WHO Health Promotion and Disease Prevention Messages Library \[21\]. It will comprise two main components: a) web-based application for children registration and automated reminder scheduling, and b) an SMS application for text messaging that is sent automatically. Messages will be sent in Urdu, the native language, and will not require a reply. Each message will include four elements: Health promotion message, visual depiction of a child's vision, a customized action plan detailing how to get to the hospital including the location, how much money is needed and what to carry with them.

Intervention arm

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Participants will only be enrolled if they meet all eligibility criteria: * Age 5 to 15 years * Detected with visual impairment on screening, * Parent in possession of or have access to smartphone * Parents have ability to receive, read and understand an SMS Children may not enter the study if any of the following apply: * Children with known refractive error (myopia) * Children with spectacles * Children with apparent eye diseases (e.g. conjunctivitis, red eye, ocular trauma, trachoma, etc.) * Plan to travel outside the city in the next two months following enrollment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Federal government schools

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (2)

  • Javed A, Mohsin S. Effectiveness of mHealth-based vision screening on uptake of referral services among children of government schools in Rawalpindi, Pakistan: study protocol for a randomised controlled trial. BMJ Open. 2025 Oct 29;15(10):e096970. doi: 10.1136/bmjopen-2024-096970.

  • Javed A, Mohsin S, Habib R, Malik UA. Effectiveness of mobile health based vision screening on uptake of referral services in school children: A randomized control trial. Pak J Med Sci. 2025 Aug;41(8):2328-2337. doi: 10.12669/pjms.41.8.11742.

Related Links

MeSH Terms

Conditions

Vision DisordersRefractive Errors

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shamaila Mohsin, PhD

    National University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The individual responsible for follow-up contacts will remain blinded to group allocation by working from a coded participant list that does not identify arm membership and will record outcomes using participant IDs only. The data analyst will receive a de-identified dataset with intervention arm masked to permit unbiased analysis.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: This study is a Concurrent parallel group, single blinded Randomized Control Trial with 1:1 allocation ratio.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Head of the department, community medicine and public health, Army medical college

Study Record Dates

First Submitted

September 22, 2024

First Posted

September 27, 2024

Study Start

October 21, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

October 7, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations