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Frequency of Visual Impairment Among School Children and Effectiveness of mHealth Referral Reminder on Uptake of Referral Services

Study Protocol for a Randomized Controlled Trial Investigating the Effectiveness of mHealth-Based Vision Screening on Uptake of Referral Services Among Children of Government Schools in Rawalpindi, Pakistan

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06616051
Enrollment
320
Registered
2024-09-27
Start date
2024-10-21
Completion date
2024-12-30
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Error, Visual Impairment

Keywords

visual impairment, mhealth, refractive error, referral reminder

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.

Detailed description

This randomized controlled trial was conducted to evaluate the effectiveness of a mobile health (mHealth)-based vision screening and automated multicomponent SMS reminder system in improving referral uptake among schoolchildren in a low-resource setting. Background: Childhood visual impairment is common in low- and middle-income countries, but referral uptake after school-based vision screening remains poor. Mobile phone penetration and parents' use of messaging platforms provide an opportunity to use SMS-based interventions to improve follow-up care. Objectives: To assess the effectiveness of mHealth-based vision screening and SMS reminders on referral uptake among visually impaired children. To explore the association of referral uptake with sociodemographic characteristics of children. Methods: This was a concurrent, parallel-group, single-blinded randomized controlled trial conducted in two Federal Government schools in Rawalpindi District, Pakistan. Children aged 5-15 years were screened for visual impairment using the validated Peek Acuity mobile application. Eligible children were randomized (school-level allocation, individual-level analysis) into two groups: Intervention group: Received a printed referral form plus multicomponent SMS reminders (including health messages, visual depiction, practical action plan, and directions to hospital). Control group: Received only the printed referral form (usual care). Enrollment began on 21 October 2024 and was completed on 26 October 2024. Follow-up assessments continued for 8 weeks, with the last follow-up completed on 30 December 2024. Sample size: A total of 80 participants were enrolled, based on sample size calculations with adjustment for 10% expected dropout. Pilot testing on 8 additional participants (not included in the main analysis) ensured feasibility. Blinding: Due to the nature of the intervention, participants and field staff could not be blinded. However, outcome assessment (via weekly telephone follow-up) and data analysis were performed by independent researchers who were blinded to group assignment. Outcomes: Primary outcome: Proportion of referred children attending the hospital within 8 weeks. Secondary outcome: Association of referral uptake with sociodemographic characteristics (e.g., age, sex, parental education). Data collection and analysis: Data were collected using the Peek-powered data collection platform, entered into encrypted devices, and analyzed with SPSS v27. An intention-to-treat approach was followed. Ethics: Ethical approval was obtained from the Ethical Review Committee, Army Medical College (NUMS). Permission to conduct the trial was provided by the FG Education Institutions Directorate, Rawalpindi. Written informed parental consent and child assent were required prior to participation. Expected impact: This trial is the first in Pakistan to evaluate the use of automated SMS reminders for improving referral uptake after school-based vision screening. Results will inform policymakers on how digital health interventions can strengthen child vision health services in resource-limited settings.

Interventions

OTHERMulticomponent SMS reminder

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.

Sponsors

Syed Fawad Mashhadi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

This study is a Concurrent parallel group, single blinded Randomized Control Trial with 1:1 allocation ratio.

Eligibility

Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of referred children who will attend the hospital within 8 weeks of referral in both groupsFollow up for 8 weeks on weekly basis after identification of visual impairmentPrimary 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.

Secondary

MeasureTime frameDescription
Secondary outcome of interest is the association of hospital attendance with sociodemographic characteristics of referred participants1 - 56 daySecondary outcome of interest is the association of hospital attendance with sociodemographic characteristics of referred participants and will be assessed by comparing the sociodemographic characteristics of referred participants who attend the hospital with those who do not, using follow-up data.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026