UMIN-CTR Clinical Trial

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

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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 or person

Institute

Self-sponsored

Institute

Department

Personal name



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

Value
https://center6.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