NCT03658980

Integrating DR Into Mainstream Health System in Bangladesh

Completed NA Results posted Last updated 16 February 2024

What this trial tests

NA trial testing Health Education Intervention in Diabetic Retinopathy in 299 participants. Completed in 31 August 2019.

Timeline

15 December 2018

Primary endpoint
31 March 2019

31 August 2019

Quick facts

Lead sponsor	Hiroshima University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	299
Start date	15 December 2018
Primary completion	31 March 2019
Estimated completion	31 August 2019
Sites	1 location across Bangladesh

Drugs / interventions tested

• Health Education Intervention

Conditions studied

• Diabetic Retinopathy — all drugs for Diabetic Retinopathy →

Sponsor

Hiroshima University

Who can join

18 and older, any sex, with Diabetic Retinopathy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Had Successful Referrals Primary · 5 months

Number of Participants Who Had Successful Referrals, resulting from a health education intervention (among non-compliant persons, i.e. those who do not avail appointment with an Eye Consultant at a tertiary hospital after being detected with probable Diabetic Retinopathy at a diabetes hospital) - to be measured using Pre and Post intervention questionnaire based on previously used questionnaires of similar published studies

Group	Value	95% CI
Health Education Intervention	92
Control Group	44

Increase in Knowledge About Diabetic Retinopathy Secondary · 5 months

The secondary outcome 'Increase in knowledge about Diabetic Retinopathy' was measured using questionnaire. Data of participants of the two arms were analyzed during post intervention survey.

Knows that long-term uncontrolled diabetes might be a cause for a vision problem known as DR

Group	Value	95% CI
Health Education Intervention	139
Control Group	59

Knows the symptoms of DR

Group	Value	95% CI
Health Education Intervention	139
Control Group	28

Knows that the onset of DR can be delayed

Group	Value	95% CI
Health Education Intervention	131
Control Group	21

Knows that DR can be treated

Group	Value	95% CI
Health Education Intervention	136
Control Group	136

Correctly indicated one of the symptoms of DR

Group	Value	95% CI
Health Education Intervention	134
Control Group	50

Correctly indicated one of the treatment option for DR

Group	Value	95% CI
Health Education Intervention	131
Control Group	35

Understands impact of non-compliance on vision

Group	Value	95% CI
Health Education Intervention	136
Control Group	129

Knows that a trained Eye Consultant at tertiary hospital provides eye care services

Group	Value	95% CI
Health Education Intervention	139
Control Group	68

Sponsor's own description

Diabetes mellitus is a leading cause of death and disability. Diabetic Retinopathy (DR) is an eye disease that affects the eyesight of about 21.3% persons with diabetes in Bangladesh in a way that is irreversible because of the nature of the disease. According to International Diabetes Federation Diabetes Atlas (5th Edition), in 2011 there were approximately 8.4 million people in the age bracket 20-79 suffering from diabetes in Bangladesh, and this number is projected to double to 16.8 million by 2030. Based on these statistics, and also according to a nationally published report, the number of persons with DR is estimated to be about 1.8 million in Bangladesh.

Taking measures to delay vision loss in persons with diabetes is more cost-effective than its treatment. Timely and effective referral of DR cases to an Ophthalmologist is very important in the prevention of this disease. The objective of this study is to identify reasons of DR referral procedure compliance and non-compliance among registered persons with diabetes in a diabetic clinic and recommend effective strategies to enhance the referral system.

The first phase of study is cross-sectional. Second phase of study is a Randomized Controlled Trial (intervention group to receive home-based health education and control group to receive standard care). It is expected that the number of registered persons with diabetes of Barishal DAB hospital who were referred to an Eye Consultant at a tertiary hospital from September 2017 - August 2018 will be N=300. All 300 participants will be eligible for inclusion in the first phase of the study. This group (est. N=300) will be categorized into compliant (est. N=120) and non-compliant participants (est. N=180). Both groups will be interviewed to understand motivation factors for compliance and de-motivation factors for non-compliance.

In the second phase of the study, the non-compliant group will be categorized further into intervention and control groups following Randomization. The intervention group will receive relevant health education messages on Diabetic Retinopathy and information about the days and times when eye care services are provided at the tertiary hospital (i.e. service availability information). They will be provided with telephonic reminders at Days 7, 30 and 90 after the health education. Then, after a gap of one month from the last telephonic reminder, both control and intervention groups will be interviewed again. In this way this study will conclude whether the health education intervention is an effective way of improving compliance rate of referred DR persons.

All questionnaires will be pre-tested in the study location. All participants will have to sign a detailed Bengali informed consent form. SPSS software will be used for data entry and analysis. Multiple Logistic Regression, along with other tests, will be used to identify variables that significantly influence successful referrals.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Health education improves referral compliance of persons with probable Diabetic Retinopathy: A randomized controlled trial.
   Khair Z, Rahman MM, Kazawa K, Jahan Y, et al · · 2020 · cited 8× · PMID 33180863 · DOI 10.1371/journal.pone.0242047