Integrating DR Into Mainstream Health System in Bangladesh
NCT03658980 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 299
Last updated 2024-02-16
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.
Conditions
Interventions
- BEHAVIORAL
-
Health Education Intervention
Face-to-face health education intervention on Diabetic Retinopathy and available services at a tertiary hospital, followed by telephonic reminder at Day 7, 30 and 90.
Sponsors & Collaborators
-
Hiroshima University
lead OTHER
Principal Investigators
-
Michiko Moriyama, RN, MSN, PhD · Hiroshima University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-15
- Primary Completion
- 2019-03-31
- Completion
- 2019-08-31
Countries
- Bangladesh
Study Locations
More Related Trials
-
Place of Glycation in Diabetic Retinopathy
NCT05364723 ·Status: UNKNOWN
-
Assessment of AI Program 'DRISTi' as a Screening Tool
NCT07222293 ·Status: RECRUITING
-
Screening Program for Type 1 Diabetes in a High-Risk Population
NCT06513247 ·Status: RECRUITING
-
Prevalence and Management Practice of Diabetic Kidney Disease at BADAS Affiliated Healthcare Centres in Bangladesh
NCT06422598 ·Status: RECRUITING
-
Early Stage Retinal Abnormalities in Type 1 Diabetes, Screened With OCT Angiography.
NCT03496597 ·Status: UNKNOWN
-
Biomarker of Diabetic Retinopathy
NCT05079399 ·Status: RECRUITING
-
Eye Screening in German Secondary Diabetes Care Centers
NCT02311504 ·Status: COMPLETED
-
Influence of Acupuncture to Ocular Microcirculation in Patients With Diabetes Mellitus
NCT01022177 ·Status: UNKNOWN ·Phase: PHASE2
-
The Retinal Function in Relation to Glucose Changes
NCT00973726 ·Status: UNKNOWN ·Phase: NA
-
The Relationship Between Stage of Diabetic Retinopathy and Retinal Blood Flow in Patients With IDDM During Euglycemic Clamp
NCT00814008 ·Status: COMPLETED ·Phase: PHASE2
-
Risk Factors for Atherogenesis in Type 1 Diabetes
NCT00035750 ·Status: COMPLETED
-
Measurement of Total Retinal Blood Flow in Patients With Diabetes and Healthy Subjects
NCT01843114 ·Status: COMPLETED ·Phase: NA
-
Electrophysiological Changes With Diet.
NCT05658991 ·Status: UNKNOWN ·Phase: NA
-
Interaction of Muscle Dystrophy, Glucose Metabolism and Insulin Sensitivity
NCT05052073 ·Status: UNKNOWN
-
Comparison of Aqueous and Plasma Glucose Level in Diabetic Patients
NCT02750098 ·Status: UNKNOWN ·Phase: NA
-
Retinal Function in Relation to Long Term Changes in the Glucose Level
NCT00973401 ·Status: UNKNOWN
-
Evaluation of Progression of Diabetic Retinopathy With Rapid Correction of Hyperglycemia
NCT02326259 ·Status: COMPLETED
-
Retinal Function in Relation to Transient or Chronic Challenges to Retinal Metabolism
NCT01721811 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of Corneal Endothelial Changes After Uneventful Phacoemulsification in Diabetic and Non-diabetic Patients in Relation to the Level of Glcosylated Hemoglobin Level
NCT05426590 ·Status: UNKNOWN ·Phase: NA
-
CORNEAL EPITHELIAL MAPPING IN DIABETICS
NCT04734158 ·Status: ACTIVE_NOT_RECRUITING
-
Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning in Patients With Type 1 Diabetes
NCT03906383 ·Status: COMPLETED ·Phase: NA
-
Measurement of Total Retinal Blood Flow and Oxygen Extraction in Patients With Diabetes and Healthy Subjects
NCT03552562 ·Status: RECRUITING ·Phase: NA
-
A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus
NCT01421355 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Combining Yoga to TENS on Diabetic Glaucoma
NCT04645992 ·Status: UNKNOWN ·Phase: NA
-
Effect of Acute Hyperglycemia on Renal Tissue Oxygenation
NCT02346149 ·Status: COMPLETED ·Phase: EARLY_PHASE1