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N/A N=299 Randomized Double-blind Prevention

Integrating DR Into Mainstream Health System in Bangladesh

Diabetic Retinopathy

Enrolled (actual)
299
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Number of Participants Who Had Successful Referrals — 92; 44 Participants — p=<0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Health Education Intervention (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Hiroshima University
Primary completion
Mar 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Who Had Successful Referrals
92; 44 <0.001 sig
SECONDARY
Increase in Knowledge About Diabetic Retinopathy
139; 59; 139; 28; 131; 21

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • atleast 18 years of age
  • Persons with diabetes who are registered with Barishal Diabetes Hospital
  • Referred to SBMC&H (tertiary hospital) for DR management (screening/treatment), from September 2017 - August 2018
  • Persons who did not undergo a Dilated Fundus Examination (DFE) in last 12 months
  • those who provide informed consent to be included in this study

Exclusion Criteria

  • Below 18 years of age
  • Persons with diabetes who are registered with Barishal Diabetes Hospital but not referred to SBMC&H (tertiary hospital) for DR management
  • Persons with diabetes referred to SBMC&H before September 2017 or after August 2018
  • Persons who have undergone a Dilated Fundus Examination (DFE) in last 12 months
  • those who do not provide informed consent to be included in this study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03658980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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