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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034552
Receipt No. 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

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Basic information
Public title Integrating Diabetic Retinopathy Into Mainstream Health System in Bangladesh
Acronym Integrating DR Into Mainstream Health System in Bangladesh
Scientific Title Integrating Diabetic Retinopathy Into Mainstream Health System in Bangladesh
Scientific Title:Acronym Integrating DR Into Mainstream Health System in Bangladesh
Region
Asia(except Japan)

Condition
Condition Patients with Diabetes
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes 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
Key secondary outcomes 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]

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 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.
Interventions/Control_2 No Intervention will be conducted in this control group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 180

Research contact person
Name of lead principal investigator
1st name Zara
Middle name
Last name Khair
Organization Hiroshima University
Division name Graduate School of Biomedical & Health Sciences
Zip code 1212
Address Dhaka 1212, Bangladesh
TEL +8801715342168
Email zara.oikee@gmail.com

Public contact
Name of contact person
1st name Zara
Middle name
Last name Khair
Organization Hiroshima University
Division name Graduate School of Biomedical & Health Sciences
Zip code 1212
Address Dhaka 1212, Bangladesh
TEL +8801715342168
Homepage URL
Email zara.oikee@gmail.com

Sponsor
Institute Self-sponsored
Institute
Department

Funding Source
Organization None (Self-sponsored)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Bangladesh Medical Research Council (BMRC)
Address BMRC Bhaban, Mohakhali, Dhaka-1212, Bangladesh
Tel 88029848396
Email info@bmrcbd.org

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Sher-e-Bangla Medical College & Hospital; Barishal Diabetes Hospital

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 17 Day

Related information
URL releasing protocol https://clinicaltrials.gov/ct2/show/NCT03658980?term=Zara+Khair&cond=Diabetic+Retinopathy&draw=2&ran
Publication of results Published

Result
URL related to results and publications https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0242047#sec020
Number of participants that the trial has enrolled 299
Results 36.1%
Results date posted
2021 Year 10 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 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.
Participant flow Total, N=299
Dropout, N=9
Total Analysed, N=290
Adverse events None reported
Outcome measures %
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 10 Month 16 Day
Date of IRB
2018 Year 12 Month 09 Day
Anticipated trial start date
2018 Year 12 Month 15 Day
Last follow-up date
2019 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 17 Day
Last modified on
2021 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039385

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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