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

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ClinicalTrials.gov Identifier: NCT03922347
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, 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


Condition or disease Intervention/treatment Phase
Visual Impairment Diagnostic Test: Screening program including 2 consecutive tests Diagnostic Test: Screening program with mobile health Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Modelling and Evaluation of a Community-oriented mHealth-based Screening and Promotional Programme for Improving Eye Health in Iran
Actual Study Start Date : April 15, 2017
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : April 10, 2019

Arm Intervention/treatment
No Intervention: routine care
Active Comparator: Screening program including 2 consecutive tests 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)

Active Comparator: Screening program with mobile health Diagnostic Test: Screening program with mobile health
Peek Acuity and Peek Retina installed on smart phones (Samsung Galaxy S8)




Primary Outcome Measures :
  1. Eye care utilization: being visited/treated by an eye care professional [ Time Frame: 6-12 months ]
    Questionnaire based on closed questions


Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: 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.


  2. fundus imaging [ Time Frame: 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.

  3. 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 ]
    visual acuity test by Snellen chart

  4. fundus imaging by fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany) [ Time Frame: At baseline ]
    fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922347


Locations
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Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences

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Responsible Party: Zahra Rabbani Khah, Head of ophthalmic research center, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03922347     History of Changes
Other Study ID Numbers: 96315
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019

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

Additional relevant MeSH terms:
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Vision Disorders
Vision, Low
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms