Clinical trial NCT04544553: Barriers to Eye Screening for People With Diabetes in India
Official title: To Understand the Barriers and Facilitators of Diabetic Retinopathy Screening & Follow-up: An Exploratory Study From India and Thailand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Edema
Keywords: screening
follow-up
short message service
Lead sponsor: Lions Club International Foundation
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Brief Summary: Diabetic retinopathy (DR) is a leading cause of visual impairment and has major public health implications globally and especially in countries such as India where the prevalence of diabetes is high. With timely screening and intervention, the disease progression to blindness can be prevented but several barriers exist to the provision of care. The long term aim is to identify the barriers to DR screening and to plan potential interventional strategies. From the qualitative study, the reasons such as lack of awareness or knowledge, distance to travel, lack of reminder system were identified as a reason for poor follow-up. This lead to the development of interventional strategies.

This was a randomized, investigator-masked clinical trial that was conducted in a tertiary eye care centre in South India. Consecutive patients with diabetes who were residents in Chennai and its vicinity of approximately 100 km radius and who were undergoing repeated intravitreal injections for DME were recruited into the trial. The aim of the study is to investigate the effect of SMS informational reminders among patients with Diabetic macular edema for the follow-up. They study consists of 2 groups, SMS reminder group receives the reminders 1 week and 2 days prior to the scheduled appointments with the concerned doctor on a particular date and time, whereas other group does not receive any reminders for the appointment schedule. After the follow-up, the patients will be screened for the attendance at the review visit.


Eligibility criteria: Inclusion Criteria:

* Adults with \> 40 years of age
* Diagnosed as centre involving Diabetic macular edema (DME)
* Patients who received intravitreal injections for DME
* Ability to give informed consent

Exclusion Criteria:

* Patients from outside the area of residence who stayed more than 100 km from the hospital
* Patients with ocular co-morbidities other than DME

Primary outcomes:
measure: Attendance rates in patients with diabetic macular edema receiving short messaging services
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: Rajiv Raman
state: Tamilnadu
Study officials:
References:
citation: Kumar G, Velu S, Prakash VJ, Kumar S, Sivaprasad S, Sharma A, Raman R. Attendance Rate in Patients with Diabetic Macular Edema Receiving Short Messages. Ophthalmol Retina. 2021 Oct;5(10):1054-1056. doi: 10.1016/j.oret.2021.03.005. Epub 2021 Mar 7. No abstract available.