mHealth Intervention for Improving Eye Health at Community Level

Phase 3

Completed

• Conditions: Visual Impairment
• Interventions: Diagnostic Test: Screening program including 2 consecutive tests; Diagnostic Test: Screening program with mobile health

• Registration Number: NCT03922347
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-15
• Primary Completion: 2018-05-15
• Status Verified: 2019-04
• Study Completion: 2019-04-10
• Study First Submitted: 2019-04-13
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-19
• Last Update Submitted: 2019-04-20
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3300

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Screening program including 2 consecutive tests	Screening program including 2 consecutive tests	-
Screening program with mobile health	Screening program with mobile health	-

Primary Outcome Measures

Name	Time	Method
Eye care utilization: being visited/treated by an eye care professional	6-12 months	Questionnaire based on closed questions

Secondary Outcome Measures

Name	Time	Method
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	visual acuity test by Snellen chart
fundus imaging	At baseline	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.
fundus imaging by fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)	At baseline	fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)
Visual acuity	At baseline	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.

Trial Locations

Locations (1)

Ophthalmic Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of