跳至主要内容
临床试验/NCT06616051
NCT06616051已完成不适用

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

Syed Fawad Mashhadi2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2024年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
320
试验地点
2
主要终点
Proportion of referred children who will attend the hospital within 8 weeks of referral in both groups

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

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

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

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.

次要结局

  • Secondary outcome of interest is the association of hospital attendance with sociodemographic characteristics of referred participants(1 - 56 day)

研究者

发起方
Syed Fawad Mashhadi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Syed Fawad Mashhadi

Professor and Head of the department, community medicine and public health, Army medical college

Rawalpindi Medical College

研究点 (2)

Loading locations...

相似试验

Frequency of Visual Impairment Among School Children... | 临床试验