Effectiveness of Google-Automated Retinal Disease Assessment (ARDA) tool assisted diabetic retinopathy screening program among people with type 2 diabetes in India-A three arm Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,125
- 试验地点
- 1
- 主要终点
- Proportion of participants who had at least one visit at ophthalmology facility (for DR screening/follow up) within three months from the date of referral
研究概览
简要总结
It is evident from the current literature that regular diabetic retinopathy (DR) screening and early treatment can prevent DR-associated vision loss. However, some DR screening programs within tertiary care settings have found low rates of patient adherence to referral recommendations, even following a positive screen for vision-threatening DR . The authors hypothesized that adherence can be increased by providing screening results immediately and improving workflows by engaging patients and, when needed, scheduling a follow-up ophthalmology appointment immediately.
The objectives of the current study are;
To test the effectiveness of Google-ARDA assisted program for screening for diabetic retinopathy (DR) among people with type 2 diabetes compared to;
1a. Standard care (referral to ophthalmology to get a retinal fundus evaluation) and
1b. Enhanced standard care (fundus images are taken at the diabetes care facility and are sent to the retina specialist for screening)
The primary outcome of the trial is the difference in proportion of participants who had at least one visit at ophthalmology facility (for DR screening/follow up) within three months from the date of referral between the three arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 89.00 Year(s)（—）
- 性别
- All
入选标准
- •With at least 3 years of diabetes duration from the date of diagnosis and Resident of Delhi-NCR and Willing/able to give consent to participate in the study.
排除标准
- •Participants who fall under any of the following criteria will be excluded: Previous diagnosis of any Diabetic Retinopathy (DR) Participants with any visual symptoms or conditions (e.g., loss of vision, blurry vision, persistent floaters), other than those corrected with glasses, contact lenses or other refractive corrections Undergone any laser treatment of the retina in the past Undergone any retinal surgeries.
结局指标
主要结局
Proportion of participants who had at least one visit at ophthalmology facility (for DR screening/follow up) within three months from the date of referral
时间窗: Three months from the date of referral
次要结局
- Time taken to adhere with referrals to eye specialist (i.e., number of days it took for participants to see ophthalmologists from the date of referral)(Measure the impact of enhanced standard care and ARDA on reducing the time between DR screening and start of ophthalmic management of a referable condition)