mHealth Intervention for Improving Eye Health at Community Level

Study Overview
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Brief Summary
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This study is a community trial that aims to establish and evaluate an mHealth screening and promotional tool for improving eye health in Iran. Sampling frame is a region in Tehran province with around 1 million sub-urban and rural inhabitants. investigators have obtained the list of health centers and their underserved population from the health authorities. In this region, health services are delivered through rural health houses, urban health posts and overhead health centers (221 units in total). investigators choose 27 units using cluster random sampling method with a probability proportional to size strategy, then investigators randomly assign them into three arms (explained below). The interventions will be at community level with the community as the unit of randomization. Arm 1- Training of the Primary Health Care (PHC) workers + PHC workers will be empowered with the mHealth tool to monitor, screen and promote community members Arm 2- PHC system will be strengthened with health promotion and screening programmes (same content as the mHealth tool) and PHC workers will deliver eye health messages and screening tests by the conventional facilities. Arm 3: Control group: only observation and registering of routine care

Official Title
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Modelling and Evaluation of a Community-oriented mHealth-based Screening and Promotional Programme for Improving Eye Health in Iran

Conditions
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Visual Impairment

Intervention / Treatment
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* Diagnostic Test: Screening program including 2 consecutive tests
* Diagnostic Test: Screening program with mobile health


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria were living in one of the non-institutionalized urban or rural residential areas in one of the survey area, being resident in the same address for at least 6 months during the year before the enrolment, age 50 and over and Iranian nationality.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: routine care<br> | |
| Active Comparator: Screening program including 2 consecutive tests<br> | Diagnostic Test: Screening program including 2 consecutive tests<br>* visual acuity test by Snellen chart, fundus imaging by fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)<br>|
| Active Comparator: Screening program with mobile health<br> | Diagnostic Test: Screening program with mobile health<br>* Peek Acuity and Peek Retina installed on smart phones (Samsung Galaxy S8)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye care utilization: being visited/treated by an eye care professional | Questionnaire based on closed questions | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Peek Acuity Software installed on smart phones (Samsung Galaxy S8, based on Logarithm Minimum Angle of Resolution, LogMAR). Visual acuity will be presented in range (minimum to maximum). Higher value of visual acuity represents the worsened outcome. | At baseline | 
| fundus imaging | Peek Retina Software installed on smart phones (Samsung Galaxy S8; based on Logarithm Minimum Angle of Resolution, LogMAR). Higher value of visual acuity represents the worsened outcome. | At baseline | 
| Based on Logarithm Minimum Angle of Resolution, LogMAR. Visual acuity will be presented in range (minimum to maximum). Higher value of visual acuity represents the worsened outcome. | visual acuity test by Snellen chart | At baseline | 
| fundus imaging by fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany) | fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany) | At baseline |