Barriers to Eye Screening for People With Diabetes in India

NCT ID: NCT04544553

Last Updated: 2020-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-24

Study Completion Date

2019-08-14

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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SMS reminder

This arm receive SMS reminder for the follow-up of DR Screening

Group Type OTHER

SMS reminder

Intervention Type OTHER

The group receives reminder for the follow-up at 1 week and 2 days prior to their scheduled appointments.

No SMS reminder

This arm did not receive SMS reminder for the follow-up of DR Screening

Group Type OTHER

No SMS reminder

Intervention Type OTHER

The group did not receives any SMS regarding scheduled appoinments.

Interventions

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SMS reminder

The group receives reminder for the follow-up at 1 week and 2 days prior to their scheduled appointments.

Intervention Type OTHER

No SMS reminder

The group did not receives any SMS regarding scheduled appoinments.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lions Club International Foundation

OTHER

Sponsor Role lead

Responsible Party

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Rajiv Raman

Senior Consultant (Ophthalmologist)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rajiv Raman

Chennai, Tamil Nadu, India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 33691182 (View on PubMed)

Other Identifiers

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731-2018-P

Identifier Type: -

Identifier Source: org_study_id

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