mHealth Intervention for Improving Eye Health at Community Level
Vison mHealth
Modelling and Evaluation of a Community-oriented mHealth-based Screening and Promotional Programme for Improving Eye Health in Iran
1 other identifier
interventional
3,300
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2019
CompletedFirst Submitted
Initial submission to the registry
April 13, 2019
CompletedFirst Posted
Study publicly available on registry
April 19, 2019
CompletedApril 23, 2019
April 1, 2019
1.1 years
April 13, 2019
April 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Eye care utilization: being visited/treated by an eye care professional
Questionnaire based on closed questions
6-12 months
Secondary Outcomes (4)
Visual acuity
At baseline
fundus imaging
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.
At baseline
fundus imaging by fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)
At baseline
Study Arms (3)
routine care
NO INTERVENTIONScreening program including 2 consecutive tests
ACTIVE COMPARATORScreening program with mobile health
ACTIVE COMPARATORInterventions
visual acuity test by Snellen chart, fundus imaging by fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)
Peek Acuity and Peek Retina installed on smart phones (Samsung Galaxy S8)
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ophthalmic Research Center
Tehran, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of ophthalmic research center
Study Record Dates
First Submitted
April 13, 2019
First Posted
April 19, 2019
Study Start
April 15, 2017
Primary Completion
May 15, 2018
Study Completion
April 10, 2019
Last Updated
April 23, 2019
Record last verified: 2019-04