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临床试验/NCT03922347
NCT03922347已完成3 期

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 个研究点 分布在 1 个国家目标入组 3,300 人开始时间: 2017年4月15日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
3,300
试验地点
1
主要终点
Eye care utilization: being visited/treated by an eye care professional

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

研究组 & 干预措施

routine care

No Intervention

Screening program including 2 consecutive tests

Active Comparator

干预措施: Screening program including 2 consecutive tests (Diagnostic Test)

Screening program with mobile health

Active Comparator

干预措施: Screening program with mobile health (Diagnostic Test)

结局指标

主要结局

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

时间窗: 6-12 months

Questionnaire based on closed questions

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zahra Rabbani Khah

Head of ophthalmic research center

Shahid Beheshti University of Medical Sciences

研究点 (1)

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