Unique ID issued by UMIN | UMIN000034552 |
---|---|
Receipt number | R000039385 |
Scientific Title | Integrating Diabetic Retinopathy Into Mainstream Health System in Bangladesh |
Date of disclosure of the study information | 2018/10/17 |
Last modified on | 2021/10/20 17:54:25 |
Integrating Diabetic Retinopathy Into Mainstream Health System in Bangladesh
Integrating DR Into Mainstream Health System in Bangladesh
Integrating Diabetic Retinopathy Into Mainstream Health System in Bangladesh
Integrating DR Into Mainstream Health System in Bangladesh
Asia(except Japan) |
Patients with Diabetes
Ophthalmology | Adult |
Others
NO
The general objective is to recommend health education intervention strategies that can be used to effectively integrate Diabetic Retinopathy into mainstream diabetes management services, by addressing gaps and strengthening the existing referral system. The specific objective is to investigate the effect of a health education intervention on patients with probable Diabetic Retinopathy who did not attend eye screening appointment with an Eye Consultant following referral from a diabetes clinic.
Efficacy
Exploratory
Pragmatic
Phase III
Increase in Successful Referrals:
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
[Time Frame: 5 months
Increase in knowledge about Diabetic Retinopathy: 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)
[Time Frame: 5 months]
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Educational,Counseling,Training
Other |
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 will be conducted in this control group
18 | years-old | <= |
Not applicable |
Male and Female
1. Atleast 18 years of age
2. Persons with diabetes who are registered
with Barishal Diabetes Hospital and referred to SBMC&H (tertiary hospital) for DR management (screening/ treatment) from September 2017 to August 2018
3. Persons who did not undergo a Dilated Fundus Examination (DFE) in last 12 months
4. Those who provide informed consent to be included in this study
1. Below 18 years of age
2. Persons with diabetes who are registered with Barishal Diabetes Hospital
but not referred to SBMC&H (tertiary hospital) for DR management
3. Persons with diabetes referred to SBMC&H before September 2017 or
after August 2018
4. Persons who have undergone a Dilated Fundus Examination (DFE) in last
12 months
5. Those who do not provide informed consent to be included in this study
180
1st name | Zara |
Middle name | |
Last name | Khair |
Hiroshima University
Graduate School of Biomedical & Health Sciences
1212
Dhaka 1212, Bangladesh
+8801715342168
zara.oikee@gmail.com
1st name | Zara |
Middle name | |
Last name | Khair |
Hiroshima University
Graduate School of Biomedical & Health Sciences
1212
Dhaka 1212, Bangladesh
+8801715342168
zara.oikee@gmail.com
Self-sponsored
None (Self-sponsored)
Self funding
Bangladesh Medical Research Council (BMRC)
BMRC Bhaban, Mohakhali, Dhaka-1212, Bangladesh
88029848396
info@bmrcbd.org
NO
Sher-e-Bangla Medical College & Hospital; Barishal Diabetes Hospital
2018 | Year | 10 | Month | 17 | Day |
https://clinicaltrials.gov/ct2/show/NCT03658980?term=Zara+Khair&cond=Diabetic+Retinopathy&draw=2&ran
Published
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0242047#sec020
299
36.1%
2021 | Year | 10 | Month | 20 | Day |
All 299 participants included in the study were referred from a diabetes hospital to a tertiary hospital in order to undergo advanced eye screening.
Participants eligible for inclusion into study were adults (18 years or above) with T2DM registered with a diabetes hospital, who had undergone preliminary screening for DR using low-resolution fundus camera at the diabetes hospital between September 2017 and August 2018, were referred to a public tertiary level hospital for advanced DR management, did not undergo a Dilated Fundus Examination (DFE) in previous 12 months and had provided informed written consent to be included in this study.
Participants who were excluded from this study were below the age of 18, persons with T2DM registered with a diabetes hospital but not referred to the public tertiary level hospital for advanced DR management between September 2017 and August 2018, persons who had undergone a DFE in previous 12 months and those who did not provide informed written consent to be included in this study.
Total, N=299
Dropout, N=9
Total Analysed, N=290
None reported
%
Completed
2018 | Year | 10 | Month | 16 | Day |
2018 | Year | 12 | Month | 09 | Day |
2018 | Year | 12 | Month | 15 | Day |
2019 | Year | 05 | Month | 15 | Day |
2018 | Year | 10 | Month | 17 | Day |
2021 | Year | 10 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039385
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