Barriers to Eye Screening for People With Diabetes in India
To Understand the Barriers and Facilitators of Diabetic Retinopathy Screening & Follow-up: An Exploratory Study From India and Thailand
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2019
CompletedFirst Submitted
Initial submission to the registry
September 3, 2020
CompletedFirst Posted
Study publicly available on registry
September 10, 2020
CompletedSeptember 14, 2020
September 1, 2020
7 months
September 3, 2020
September 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Attendance rates in patients with diabetic macular edema receiving short messaging services
To investigate the effect of SMS informational reminders on adherence with scheduled eye examinations among patients with center involving DME receiving intravitreal injections in a tertiary eye care institute in South India.
7 months
Study Arms (2)
SMS reminder
OTHERThis arm receive SMS reminder for the follow-up of DR Screening
No SMS reminder
OTHERThis arm did not receive SMS reminder for the follow-up of DR Screening
Interventions
The group receives reminder for the follow-up at 1 week and 2 days prior to their scheduled appointments.
The group did not receives any SMS regarding scheduled appoinments.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients from outside the area of residence who stayed more than 100 km from the hospital
- Patients with ocular co-morbidities other than DME
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rajiv Raman
Chennai, Tamil Nadu, 600006, India
Related Publications (1)
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.
PMID: 33691182DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Consultant (Ophthalmologist)
Study Record Dates
First Submitted
September 3, 2020
First Posted
September 10, 2020
Study Start
January 24, 2019
Primary Completion
August 14, 2019
Study Completion
August 14, 2019
Last Updated
September 14, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share
The datasets generated during and/or analysed during the study are not publicly available, as it against the organization hospital policy. But are available from the corresponding author on reasonable request.