Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03658980 |
| Other study ID # |
HiroshimaUniversity |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2018 |
| Est. completion date |
August 31, 2019 |
Study information
| Verified date |
July 2023 |
| Source |
Hiroshima University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Diabetes is a non-communicable chronic disease associated with abnormally high levels of the
glucose in the blood. One of the many complications of diabetes is Diabetic Retinopathy (DR),
which results in vision problems in persons suffering from diabetes for many years.
DR is the fifth leading cause of global blindness, affecting an estimated 1.8 billion people
and responsible for 4.8% of all causes of blindness. According to International Diabetes
Federation (IDF) Atlas, Bangladesh is a least developed country (LDC) with a
disproportionately high proportion of people having diabetes. Among all people living with
diabetes in the 48 LDCs, about 40% live in Bangladesh, which makes it one of the top 10
countries suffering from diabetes. In Bangladesh, approximately 6.1% of the population aged
20-79 years has diabetes, with approximately 46% of these undiagnosed. 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. Diabetic
Retinopathy (DR) and Diabetic Macular Edema (DME) are common complications of diabetes that
can result in vision loss - the estimated number of people with DR in Bangladesh is about 1.8
million (21.3% of the diabetic persons).
From a patient perspective there is little or no integration between the eye health sector
and the diabetes sector. In Bangladesh, care for diabetes-related eye disease is available in
very few tertiary level health facilities. There is currently no eye health care available
for people with diabetes or those suffering from DR, at the community clinics, primary health
care centers or secondary health care centers (The Fred Hollows Foundation, 2015).
An effective referral system is a 'critical component of quality clinical care'. When
utilized optimally, it can solve more public health problems in less time by directing cases
through an appropriate channel.
DR Screening is very important, because early stages of the disease lack symptoms - when
symptoms occur the disease already requires treatment. DR Screening centers may have to refer
persons in a timely and effective manner to a DR treatment center. Early detection and timely
referral are critical for timely interventions to prevent further deterioration of vision. In
the case of DR, an effective referral system is crucial for the success of the disease
management. This is because knowledge, awareness and perceived benefit of receiving DR
Management services among persons with diabetes is very low, the world over, and more so in
Bangladesh. Therefore, in order to make sure that DR Management is effectively integrated
into mainstream public health in Bangladesh, it is vital to address one of the most
challenging components of DR management, which is, strengthening referral system for persons
having DR. If a person with diabetes is not made aware about possible consequences of
negligence of eye problem, is not properly counseled to undertake DR treatment and is not
made aware of the existing DR referral pathway, the person will in all probability forego
treatment, since the perceived benefit of DR treatment is low among persons who lack
symptoms.
The Research Question is 'How can we increase the number of successful referrals of Diabetic
Retinopathy persons from a diabetes clinic (DAB center) to an Eye Consultant located at a
tertiary hospital?' The general objective is to recommend health education messages regarding
DR and intervention strategies to benefit people who are at risk of developing DR or has
already developed DR.
The specific objective is to investigate the effect of a health education intervention on
persons with probable Diabetic Retinopathy who did not attend eye screening appointment with
an Eye Consultant following referral from a diabetes clinic.
The primary outcome is 'Increase in Successful Referrals' and the secondary outcome is
'Increase in knowledge of Diabetic Retinopathy'.
RATIONALE:
A diabetic clinic should ideally be a 'one-stop-care center' that offers holistic care for
people with diabetes. DR persons may be diagnosed or undiagnosed persons with diabetes.
Before a person is screened or treated for DR, ideally that person must first be diagnosed
with diabetes, and brought under comprehensive diabetes care management. Comprehensive
diabetes care management includes management of diseases of organs including kidneys, heart,
tooth, brain and eyes. Yet many undiagnosed persons with diabetes who suffer from DR may also
walk into eye clinics, requiring urgent attention. In such cases, it is best to manage DR
first and then refer the person to a diabetes clinic, so that person can be brought under
comprehensive diabetes management. Controlling and managing diabetes will ensure that the DR
condition of person does not deteriorate. Management of diabetes ensures that DR is
controlled or prevented. It is a well-established fact that prevention of DR is more
cost-effective than its treatment. In order to delay the onset of DR, it is important that
referred DR persons from Barisal DAB Center promptly uptakes services at the referred
facility, i.e. the tertiary hospital. Referred persons should ideally avail advanced DR
management and treatment options without further loss of time.
In the study location (i.e. Barisal district), there are approximately 21000 persons
suffering from varying stages of DR.
Sher-e-Bangla Medical College and Hospital (SBMC&H) has been providing eye care services for
a long time to the community, and has recently started to provide eye care services to
persons suffering from Diabetic Retinopathy. Their services include eye screening and
treatment for DR persons. The Eye Consultant in this hospital has received reputed
international training. Most of the people who came to seek DR management services at SBMC&H
in 2017 and 2018 are persons with diabetes, registered with the Barishal DAB center, who have
been referred from Barisal DAB center to SBMC&H (The Fred Hollows Foundation Bangladesh,
2018).
Diabetes clinics are one-stop-care-center for most registered persons with diabetes. Barisal
DAB center is visited by thousands of persons with diabetes each year. If a person with
diabetes is referred to an Eye Consultant of a tertiary hospital for advanced DR screening
and management, most of the referred persons to not avail services in the tertiary hospital,
due to lack of awareness, motivation and other barriers. These 'non-compliant' persons maybe
assumed to 'drop out' of the health system (The Fred Hollows Foundation Bangladesh, 2018).
Barisal DAB center provides diabetes management services to registered persons with diabetes,
and has in recent year started to provide eye care services to persons suffering from DR (The
Fred Hollows Foundation Bangladesh, 2017). Its services include screening for probable DR
cases. The medical personnel in this hospital has received training to screen for probable DR
cases, and then refer these probable cases to an Eye Consultant for advance screening and
management (preferably at SBMC&H since it provides DR treatment and is located nearby). From
the records from the year 2017 and 2018, it has been found that most referred persons of
Barishal DAB center do not avail their appointment at the referred facility (non- compliant
persons). These non-compliant persons are probable priority DR persons who need immediate
medical attention (this risk group also has diabetes for more than 5 years, and/or a family
history of diabetes, and/or a higher range of Body Mass Index along with worsening eye
conditions) (The Fred Hollows Foundation Bangladesh, 2018).
Chances are these same registered persons with diabetes (who have been referred from Barisal
DAB center to an Eye doctor) will visit Barisal DAB center in future again for continued
management of diabetes and other complication management. These high-risk persons can be
followed-up with, regarding their eye screening appointment at SBMC&H (The Fred Hollows
Foundation Bangladesh, 2018). This is because timely referral is critical for DR persons, in
order to delay further deterioration of their vision, and DR persons need to complete the
referral cycle in a prompt manner. That is, the number of successful referrals (or completed
referrals) is an important indicator.
From a patient perspective, the referral pathway should be clear and specific. Patients
require specific information not only about the disease management, but also about the
referred facility, such as days and times of services, how to travel to the referred
facility, and so on. Through the health education component in this research, non-compliant
persons will be provided with this type of information, which will help them decide when and
how to access tertiary level care. In this way, the non-compliance rate may be minimized.
This study will highlight health education messages and possible health education delivery
strategies, targeting DR persons.
The first phase of study is cross-sectional. The second phase of study is a Randomized
Controlled Trial (intervention group to receive home-based health education and control group
to receive standard care).
- Variables used in study: Education, Occupation, Income, Age, Sex, District of residence,
DR Stage, time taken to travel to health facility, knowledge of DR, source of
information on DR, accompanying person, decision maker, information received at diabetes
clinic, counseling received at diabetes clinic, follow up/reminder calls about
appointment with Eye Consultant, clarity about referral procedure
(place/time/location/how to get there), satisfaction with health facilities,
understanding of non-compliance on vision.
- Study Population: Registered persons with diabetes, who are/will be detected with
probable DR and referred for specialty DR services at Sher-e-Bangla Medical College and
Hospital (both groups will be studied - those who uptake services and those who do not,
i.e. compliant and non-compliant persons)
- Inclusion criteria: All diabetic persons registered at Barisal DAB who are referred to
SBMC&H for DR management (screening/treatment), from September 2017 - August 2018 (i.e.
during these 12 months) are eligible for inclusion in this study. Also, participants
have to be atleast 18 years of age and will provide informed consent to be included in
the research study. Only those persons will be included who did not undergo a Dilated
Fundus Examination (DFE) in last 12 months.
- Exclusion criteria: Persons with diabetes who are registered at Barisal DAB but are not
referred to SBMC&H for DR management (screening/treatment), from September 2017 - August
2018 (i.e. during these 12 months) are excluded from this study. Persons below 18 years
of age, and those who do not provide informed consent to be included in the research
study, are excluded from the study. Persons who have undergone a Dilated Fundus
Examination (DFE) in last 12 months will also be excluded from this study.
- Primary Outcome: Increase in Referral Rate (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 DR at a diabetic hospital)
- Secondary Outcome: Increase in knowledge of Diabetic Retinopathy and service
availability
- Statistical basis of the sample size: All diabetic persons registered at Barisal DAB who
were referred to Barisal Sher-e-Bangla Medical College and Hospital after screening for
probable DR (at the DAB clinic) from September 2017 - August 2018 are eligible for
inclusion in this study. The total expected number of referred persons referred from
September 2017 - August 2018 is expected to be about N=¬300 based on trend analysis (of
monthly data from September 2017 - April 2018). All persons will be interviewed (both
compliant and non-compliant persons). ¬ This number (N=300) was calculated based on the
following parameters: Confidence Interval = 95%; population of probable DR persons in
Barisal district = 20,000; Power = 0.8; Standard Deviation = 10%
- Methods of Data Collection: After completion of informed consent forms, face-to-face
In-depth Interviews (IDI) with all participants will be conducted.
- Pre-testing: Questionnaires will be pre-tested in the study location
- Data Interpretation: Responses to questions will be coded and entered into SPSS
software, which will then be used to analyze and interpret data.
- Statistical Analysis: Frequency distributions will be used to analyze the demographic
characteristics of the study population. Multiple Logistic Regression method will be
used to identify variables that significantly influence successful and unsuccessful
referrals among compliant and non-compliant persons. For the RCT study among
non-compliant persons to find impact of health education intervention, the primary
outcome (successful referral rate - defined as attendance at referred facility) and
secondary outcome (increase in knowledge of Diabetic Retinopathy and service
availability) will be compared between both arms. For continuous measures the t-test
will be used and for categorical outcomes, chi-square test will be use, when comparing
the two arms (i.e. intervention and control groups).
There are no reasonable foreseeable risks in this study. Participants will be made aware
about the confidentiality issues, study procedures, modalities, and their rights to refuse to
answer/withdraw at any point without any monetary/non-monetary loss. This study is anonymous.
Investigator will not be collecting or retaining any information about participant identity.
The records of this study will be kept strictly confidential. Publications will not contain
any information that may make it possible to identify participants. Participants will not
receive any monetary benefits for participating in this study. They will be informed about
this before the start of the survey. They will be required to sign a detailed consent form
that they can read in Bengali and have a witness sign. One copy of this will be provided to
the participant.
