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mHealth Intervention for Improving Eye Health at Community Level (Vison mHealth)

Primary Purpose

Visual Impairment

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Screening program including 2 consecutive tests
Screening program with mobile health
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Visual Impairment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ophthalmic Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

routine care

Screening program including 2 consecutive tests

Screening program with mobile health

Arm Description

Outcomes

Primary Outcome Measures

Eye care utilization: being visited/treated by an eye care professional
Questionnaire based on closed questions

Secondary Outcome Measures

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.
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.
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
fundus imaging by fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)
fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)

Full Information

First Posted
April 13, 2019
Last Updated
April 20, 2019
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03922347
Brief Title
mHealth Intervention for Improving Eye Health at Community Level
Acronym
Vison mHealth
Official Title
Modelling and Evaluation of a Community-oriented mHealth-based Screening and Promotional Programme for Improving Eye Health in Iran
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
April 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
routine care
Arm Type
No Intervention
Arm Title
Screening program including 2 consecutive tests
Arm Type
Active Comparator
Arm Title
Screening program with mobile health
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Screening program including 2 consecutive tests
Intervention Description
visual acuity test by Snellen chart, fundus imaging by fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)
Intervention Type
Diagnostic Test
Intervention Name(s)
Screening program with mobile health
Intervention Description
Peek Acuity and Peek Retina installed on smart phones (Samsung Galaxy S8)
Primary Outcome Measure Information:
Title
Eye care utilization: being visited/treated by an eye care professional
Description
Questionnaire based on closed questions
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Visual acuity
Description
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.
Time Frame
At baseline
Title
fundus imaging
Description
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.
Time Frame
At baseline
Title
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.
Description
visual acuity test by Snellen chart
Time Frame
At baseline
Title
fundus imaging by fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)
Description
fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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mHealth Intervention for Improving Eye Health at Community Level

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