Integrating DR Into Mainstream Health System in Bangladesh
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|ClinicalTrials.gov Identifier: NCT03658980|
Recruitment Status : Not yet recruiting
First Posted : September 6, 2018
Last Update Posted : September 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy||Behavioral: Health Education Intervention||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Integrating Diabetic Retinopathy Into Mainstream Health System in Bangladesh|
|Estimated Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||March 31, 2019|
Experimental: Health Education Intervention
Face-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.
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.
No Intervention: Control Group
No Intervention will be conducted in this control group
- Increase in Successful Referrals [ Time Frame: 5 months ]Increase in 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
- Increase in knowledge about Diabetic Retinopathy [ Time Frame: 5 months ]Increase in knowledge about Diabetic Retinopathy (to be measured using Pre and Post intervention questionnaires based on previously used questionnaires of similar published studies; a total of 9 questions will be allotted to assess participants' knowledge on Diabetic Retinopathy. Accurate response rates regarding knowledge about Diabetic Retinopathy will be calculated by scoring responses out of 9. Participants who correctly answer atleast 7 will be considered to have good knowledge on Diabetic Retinopathy)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658980
|Contact: Zara Khair, MDSfirstname.lastname@example.org|
|Study Director:||Michiko Moriyama, RN, MSN, PhD||Hiroshima University|