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Clinical Trials/NCT03922347
NCT03922347CompletedPhase 3

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

Shahid Beheshti University of Medical Sciences1 site in 1 country3,300 target enrollmentStarted: April 15, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
3,300
Locations
1
Primary Endpoint
Eye care utilization: being visited/treated by an eye care professional

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

routine care

No Intervention

Screening program including 2 consecutive tests

Active Comparator

Intervention: Screening program including 2 consecutive tests (Diagnostic Test)

Screening program with mobile health

Active Comparator

Intervention: Screening program with mobile health (Diagnostic Test)

Outcomes

Primary Outcomes

Eye care utilization: being visited/treated by an eye care professional

Time Frame: 6-12 months

Questionnaire based on closed questions

Secondary Outcomes

  • 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(At baseline)
  • fundus imaging by fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)(At baseline)
  • Visual acuity(At baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zahra Rabbani Khah

Head of ophthalmic research center

Shahid Beheshti University of Medical Sciences

Study Sites (1)

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