mHealth Intervention for Improving Eye Health at Community Level

Visual Impairment Clinical Trial

— Vison mHealth  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922347
• Other study ID #: 96315
• Status: Completed
• Phase: Phase 3
• Start date: April 15, 2017
• Est. completion date: April 10, 2019

Study information

• Verified date: April 2019
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3300
• Est. completion date: April 10, 2019
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Diagnostic Test:
• Screening program including 2 consecutive tests
visual acuity test by Snellen chart, fundus imaging by fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)
• Screening program with mobile health
Peek Acuity and Peek Retina installed on smart phones (Samsung Galaxy S8)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eye care utilization: being visited/treated by an eye care professional	Questionnaire based on closed questions	6-12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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