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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
Sponsor:
Information provided by (Responsible Party):
Zara Khair, Hiroshima University

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.


Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Behavioral: Health Education Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Zara Khair, MDS 8801715342168 zara.oikee@gmail.com

Sponsors and Collaborators
Hiroshima University
Investigators
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Study Director: Michiko Moriyama, RN, MSN, PhD Hiroshima University

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Responsible Party: Zara Khair, Principal Investigator, Hiroshima University
ClinicalTrials.gov Identifier: NCT03658980     History of Changes
Other Study ID Numbers: HiroshimaUniversity
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zara Khair, Hiroshima University:
Diabetes Mellitus
Diabetic Retinopathy
Referral

Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases