Integrating DR Into Mainstream Health System in Bangladesh
Integrating Diabetic Retinopathy Into Mainstream Health System in Bangladesh
1 other identifier
interventional
299
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2018
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
First Submitted
Initial submission to the registry
August 25, 2018
CompletedFirst Posted
Study publicly available on registry
September 6, 2018
CompletedStudy Start
First participant enrolled
December 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedResults Posted
Study results publicly available
February 16, 2024
CompletedFebruary 16, 2024
July 1, 2023
4 months
August 25, 2018
August 4, 2020
July 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Had Successful Referrals
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
5 months
Secondary Outcomes (1)
Increase in Knowledge About Diabetic Retinopathy
5 months
Study Arms (2)
Health Education Intervention
EXPERIMENTALFace-to-face health education session on Diabetic Retinopathy and available services at a tertiary hospital, followed by telephonic reminders at Day 7, 30 and 90.
Control Group
NO INTERVENTIONNo Intervention will be conducted in this control group
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sher-e-Bangla Medical College & Hospital
Barishal, 8200, Bangladesh
Related Publications (1)
Khair Z, Rahman MM, Kazawa K, Jahan Y, Faruque ASG, Chisti MJ, Moriyama M. Health education improves referral compliance of persons with probable Diabetic Retinopathy: A randomized controlled trial. PLoS One. 2020 Nov 12;15(11):e0242047. doi: 10.1371/journal.pone.0242047. eCollection 2020.
PMID: 33180863DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Zara Khair
- Organization
- Hiroshima University
Study Officials
- STUDY DIRECTOR
Michiko Moriyama, RN, MSN, PhD
Hiroshima University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 25, 2018
First Posted
September 6, 2018
Study Start
December 15, 2018
Primary Completion
March 31, 2019
Study Completion
August 31, 2019
Last Updated
February 16, 2024
Results First Posted
February 16, 2024
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share