Implementation of smart phone-based fundus camera screening for Diabetic Retinopathy, Hypertensive Retinopathy and Age-related Macular Degeneration in rural primary care: a mixed methods study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- •Evidence on Implementation outcomes: acceptability, feasibility, sustainability, fidelity of CHO led smartphone-based DR screening of Hypertensive Retinopathy (HR), and Age-Related Macular Degeneration (ARMD).
研究概览
简要总结
This study aims to evaluate the implementation of smartphone-based fundus camera screening for diabetic retinopathy, hypertensive retinopathy, and age-related macular degeneration in rural primary healthcare settings of Odisha. The objective is to assess the feasibility, acceptability, and integration of this screening method when performed by Community Health Officers at sub centers. The study will use a mixed methods approach including quantitative screening data and qualitative insights from patients, health workers, and other stakeholders. Findings will help identify facilitators, barriers, and system level recommendations for scaling up retinal screening services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Adults aged eighteen years and above with a known diagnosis of hypertension or currently taking antihypertensive medication.
- •2 Adults aged eighteen years and above with a documented diagnosis of hypertension, defined as: Stage 1 Hypertension: Systolic blood pressure between one hundred thirty and one hundred thirty-nine millimetres of mercury or diastolic blood pressure between eighty and eighty-nine millimetres of mercury.
- •Stage 2 Hypertension: Systolic blood pressure of one hundred forty millimetres of mercury or higher, or diastolic blood pressure of ninety millimetres of mercury or higher.
- •3 Adults aged eighteen years and above with a known diagnosis of type 1 diabetes mellitus for at least five years.
- •4 Adults aged eighteen years and above with a known or newly diagnosed case of type 2 diabetes mellitus.
- •5 Newly diagnosed individuals meeting at least one of the following criteria: Fasting Plasma Glucose of one hundred twenty-five milligrams per decilitre or higher.
- •Two-hour plasma glucose after seventy-five grams oral glucose load of two hundred milligrams per decilitre or higher.
- •Random Blood Sugar of two hundred milligrams per decilitre or higher.
- •Glycated haemoglobin (HbA1c) of six point five percent or higher.
- •6 Individuals with both diabetes and hypertension will not be included.
- •7 Adults aged fifty years and above, irrespective of known chronic disease status, for screening of age-related macular degeneration.
排除标准
- •1 Eyes with media opacities, such as dense cataract, that make it impossible to visualize the retina.
- •2 Participants already diagnosed and currently undergoing active treatment for retinal conditions, such as those who have previously received laser therapy, intravitreal injections, or retinal surgery.
结局指标
主要结局
•Evidence on Implementation outcomes: acceptability, feasibility, sustainability, fidelity of CHO led smartphone-based DR screening of Hypertensive Retinopathy (HR), and Age-Related Macular Degeneration (ARMD).
时间窗: 3 months
•Benefits of the Implementation
时间窗: 3 months
•System-level recommendations for scale-up
时间窗: 3 months
次要结局
未报告次要终点
研究者
Dr Adyasha Das
ICMR-RMRCBB