Clinical trial NCT06616051: Frequency of Visual Impairment Among School Children and Effectiveness of mHealth Referral Reminder on Uptake of Referral Services
Official title: Effectiveness of Mobile Health Based Vision Screening on Uptake of Referral Services in School Children: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Visual Impairment
Refractive Error
Keywords: visual impairment
mhealth
refractive error
referral reminder
Lead sponsor: Rawalpindi Medical College
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 320
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a Multicenter, Concurrent parallel group, single blinded Randomized Control Trial with 1:1 allocation ratio.
Primary purpose: SCREENING

Brief summary: The goal of this RCT is to assess the frequency of visual impairment among school children using mHealth based vision screening to assess the effectiveness of mHealth on uptake of referral services among identified visually impaired school children.

It aimed to answer, does mobile health (mHealth) referral reminder Vs no mobile health reminder affect the uptake of referral services in identified visually impaired school children? The study will be performed in Rawalpindi district of Punjab province. Within this city, there are 22 FG schools. The selection of Federal Government schools was made owing to the fact that children studying in FG school belong to low to middle income communities. The study is done in order to provide access to screening services to low income communities and raise awareness for uptake of referral system.

The Primary outcome will be proportion of referred children who will attend the hospital within 8 weeks of referral while the secondary outcome will be the frequency of visual impairment among school children.

Children who tested positive for vision impairment will be handed referral forms, the parents or guardians of the children in the intervention group also received a text message reminder. The participant will get messages on Sundays, Tuesdays, and Thursdays until they visit the hospital for a maximum duration of eight weeks.

The outcome of intervention group will be compared with the control group. To determine the percentage of referred children who visit the hospital, a telephone follow-up will be conducted and the filled in referral form will be returned to the teacher.

Detailed description: This study will be a multicenter, concurrent parallel group, single blinded Randomized control trial with 1:1 allocation ratio. Study will be conducted in four Federal Government (FG) schools in Rawalpindi city of Punjab province in Pakistan. The Army Medical College Ethical Review Committee will authorize the study protocol. The FG Directorate Education Institutions Rawalpindi would grant permission for the research to be conducted. All participants will provide their assent, and parents or guardians will be asked to provide written, informed consent for their kid to participate. The principal investigator will provide one day of training to the researchers on the screening and data collection procedure.

According to Clinical Calculator (https://clincalc.com/stats/samplesize.aspx) for sample size calculation with ∞ = 0.05 and Power of 80 the sample size was found to 272 but the adjusted sample size with 20% expected dropouts = sample size (1+dropout rate) =320 (160:160) The population within the age range of 5-15 years will be targeted (WHO recommends the priority age group for vision screening as 5 -15 years in Vision and eye screening implementation hand book 2024 https://www.who.int/publications-detail-redirect/9789240082458, 2024). Our study population will be school children.

Study participants will be selected through probability sampling in two stages. In first stage simple random sampling will be used. A list of all Federal Government schools of Rawalpindi will be obtained from Directorate Federal Government Education Institutes (FGEI). Out of them four school will be selected through computer generated random numbers. In second stage, children will be selected through stratified random sampling. Children divided into four strata on the basis of age and gender. Then 20 children will be selected from each stratum. Eighty children will be selected from each school to complete the sample size of 320.The FG Directorate Education Institution will provide approval. A meeting with the principals of the FG schools will be organized to discuss the goal of the research. There will be a promotional speech given in the school to parents and pupils. Parents and children will receive consent and assent forms, respectively.

Child eligibility is evaluated. Parents and children will get the consent form and the assent form. Investigator will provide one day training to researchers and data collector regarding baseline, data collection procedure, follow- up data collection and use of data collection tools. The training will also cover how to utilize the smartphone acuity app for visual screening. Using a medical torch, participants will be checked for any external eye pathologies, such as ocular trauma, conjunctivitis, red eye, and swelling of the lids. . Visual acuity app and complete software with data collection platform and SMS reminder functionality will be used. The distance visual acuity cut-off is four out of the five optotypes at 6/12 level at a distance of three meters. Every eye had to be examined separately at the proper 3 meter test distance. Every child who tested positive for vision impairment was handed a referral form.

Randomization will be conducted in three steps:

Sequence generation: Using a computerized random number generator program (https://www.sealedenvolope.com/), schools will be allotted in a 1:1 ratio. An independent Community medicine resident will be assigned to create cards for random assignment. Card kept sealed in opaque envelopes with sequential numbers.

Concealment mechanism: The researcher will not be aware of the allocation sequence, enrolling and assessing the participants. After allocation, the principal investigator will write the school name on each envelope to prevent the random allocation from being manipulated.

Implementation: Random assignment cards are generated by independent community medicine residents. After a baseline evaluation and visual screening, a trained researcher will enroll the participants, and the principal investigator will assign the school to the intervention or control group.

Blinding: It will not be possible to blind the study participants or the data collectors due to the nature of the intervention. Conversely, during the course of the trial, the person who will conduct the follow-up and data analysts will be kept blinded.

Among Intervention group, children who tested positive for visual impairment will be handed referral forms, and their parents or guardians also received a text message reminder. The participant will get messages on Sundays, Tuesdays, and Thursdays until they visit the hospital for a maximum duration of eight weeks.

An automated text message reminder system will be developed for this study. Our research team created the text message, taking into account the local context. The message was framed with assistance from a panel of public health consultant and research supervisors. WHO health promotion and prevention messages library from "Vision and Eye Screening Implementation handbook" (Available at https://www.who.int/publications-detail-redirect/9789240082458, 2024) has also been utilized. Two parts make up the computerized text message reminder system: an SMS application for text messaging that is sent automatically and a web-based application for child registration and automated reminder scheduling. The parents will get text messages written in Urdu, the native language, as part of the intervention. Mothers will receive instruction on how to access and interpret the messages. The message consists of four parts and will be sent as an SMS: Health promotion message, visual depiction of child vision, a customized action plan with details on how to get to the hospital including the location and a snapshot of the key location, how much money is needed, and what to carry with them is provided.

While among the control group, external eye examination and visual acuity App based vision screening will be done. The participants screened positive for visual impairment in the control group will receive a referral form.

The principal investigator will give one-day training to researchers and data collectors on baseline, data collection procedures, follow-up data collection, and the use of data collection tools. The training will cover how to utilize the smartphone acuity app for visual screening.

There are five steps involved in gathering data. Child demographic profile, a distant visual acuity test, the percentage of recognized visually impaired children who are sent to the hospital, and the percentage of referred children who will visit the hospital within eight weeks of the referral and using a validated questionnaire to assess any risk factor related to visual impairment are all included.

Baseline data (name, age, date of birth, educational attainment, and parent contact number) will be gathered from study participants during enrollment in both the intervention and control groups. Data will be collected on a validated data collection tool. To collect data, an English language structured questionnaire will be created based on previously published literature. Furthermore, a validated questionnaire will be utilized to assess the risk factors associated with visual impairment.

To determine the percentage of referred children who visit the hospital, a telephone follow-up will be conducted and the filled in referral form will be returned to the teacher.

Using data collection instruments that have been piloted and validated will guarantee the quality of the study outputs. Prior to the actual data collection, a pilot test will be conducted. Throughout the entire follow-up, there will be constant surveillance. Additionally, principal investigator will oversee the computerized program that reminds participants via text message and oversee the entire study project. Double data entry will be made in order to detect and correct data entry errors.

Eligibility criteria: Inclusion Criteria:

* All pupils falling in age bracket of 5 to 15 years
* Parents' consent in writing on the given consent form timely submitted to teachers
* Parents having smart phone is mandatory for child's participation

Exclusion Criteria:

* Children who are already diagnosed with any visual impairment
* Child with any apparent eye pathology (conjunctivitis, red eye, ocular trauma, trachoma)

Primary outcomes:
measure: Proportion of referred children who will attend the hospital within 8 weeks of referral
timeFrame: Follow up for 8 weeks on twice weekly basis after identification of visual impairment
Secondary outcomes:
measure: Time taken by the participants to attend the referral
timeFrame: 1 - 56 day
Other outcomes:
Locations:
Study officials:
affiliation: National University of Medical Sciences
name: Shamaila Mohsin, PhD
role: PRINCIPAL_INVESTIGATOR
References: