UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000039385