Visual ImpairmentNCT06616051
Frequency of Visual Impairment Among School Children and Effectiveness of mHealth Referral Reminder on Uptake of Referral Services
A study testing Multicomponent SMS reminder in people with Visual Impairment and Refractive Error, run by Syed Fawad Mashhadi at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment, Refractive Error
- What is being tested?
- Multicomponent SMS reminder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Oct 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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.
Read the 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.
- Conditions
- Visual Impairment, Refractive Error
- Being tested
- Multicomponent SMS reminder
- Keywords
- visual impairment, mhealth, refractive error, referral reminder
- Medical subject headings
- Vision Disorders, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent SMS reminderOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Secondary 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.
Measured: 1 - 56 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start21 Oct 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a Concurrent parallel group, single blinded Randomized Control Trial with 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syed Fawad Mashhadi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Syed Fawad Mashhadi, Rawalpindi Medical College
- Investigators
- Shamaila Mohsin, PhD, Study director, National University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616051
- Sponsor's protocol ID
- vision320rct
- Status last verified
- Oct 2025
- First submitted
- 22 Sep 2024
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41161831Javed 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.
PubMed 40980391
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06616051
- Acronym / sponsor ID
- vision320rct
- Conditions
- Visual Impairment, Refractive Error
- Keywords
- visual impairment, mhealth, refractive error, referral reminder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Syed Fawad MashhadiUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a Concurrent parallel group, single blinded Randomized Control Trial with 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Multicomponent SMS reminderParents 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. |
| 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. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent SMS reminderSMS 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. | Other | Intervention arm |
Primary outcome
Proportion of referred children who will attend the hospital within 8 weeks of referral in both groups
Time frame: 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.
1 secondary outcome
Secondary outcome of interest is the association of hospital attendance with sociodemographic characteristics of referred participants
Time frame: 1 - 56 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Derived from this study: PubMed 41161831Javed 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.
- Derived from this study: PubMed 40980391Javed 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.
- The Global Burden of Disease (GBD) study provides a comprehensive picture of mortality and disability across countries, time, age, and sex.Link provided by the sponsor.
- Telecom Indicators, WHO fact sheet on blindness and visual impairment providing key facts, definitions, causes.Link provided by the sponsor.
- The IAPB Vision Atlas presents the very latest eye health data and evidence.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shamaila Mohsin, PhD study director
National University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent SMS reminder in people with Visual Impairment and Refractive Error, run by Syed Fawad Mashhadi at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of referred children who will attend the hospital within 8 weeks of referral in both groups (time frame: Follow up for 8 weeks on weekly basis after identification of visual impairment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06616051, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.