Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04829084 |
| Other study ID # |
REMEH/ERB/582/2020 P |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 26, 2021 |
| Est. completion date |
December 30, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
Seva Foundation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Reiyukai Eiko Masunaga Eye Hospital (REMEH) is a non-profitable organization. Retina services
were resumed from October 2019. Until this retinal service started, it has been mostly
cataract-focused. People are unaware of this new retinal service in the hospital. The
investigators would like to fill this gap and our objective is to increase the attendance of
patients with Diabetes Mellitus, for retinal screening at REMEH by providing health education
intervention to selected physicians and establish a referral pathway.
Study Design: pre- post-intervention Methods: The investigators are going to conduct
intervention by providing health education on diabetes Retinopathy to the health personnel of
Scheer Memorial Hospital. It has been referring eye patients to REMEH as there is no eye
department there.
Data Management: The demographic information of health personnel of Sheer memorial and
demographic information and other variables of the patient who are referred from Scheer
Hospital will be collected and entered in an excel sheet.
The study period of approximately 16 months (March 2020 to Sep 2021): Initial 10 months for
proposal writing, preparation, and getting ethical approval. Feb2021 - April 2021 three
months for pretest intervention May- July further data collection and last two months Aug-
Sep Analysis and writing result.
Results: The proposed outcome is to increase the proportional change in the number of
patients availing retinal services and to find out a proportional increase in the number of
diabetes screenings from the baseline. Also, a positive outcome is a clear indication for
health education, and setting communication between general physicians and specialties will
set the path for improvement in a timely health care delivery system.
Description:
Diabetes Mellitus (DM) is a chronic, metabolic disease characterized by elevated levels of
blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood
vessels, eyes, kidneys, and nerves. People with diabetes can develop an eye disease called
Diabetic Retinopathy when high blood sugar levels damage the blood vessels in the retina.
Diabetic Retinopathy if detected early can be treated to preserve the vision. Once the vision
has been lost it cannot usually be restored. Diabetic retinopathy is an emerging cause of
blindness in developing countries. Diabetic retinopathy is a common and specific
microvascular complication of diabetes and remains the leading cause of preventable blindness
in working-aged people. It is identified in a third of people with diabetes and associated
with an increased risk of life-threatening systemic vascular complications, including stroke,
coronary heart disease, and heart failure.
The worldwide prevalence of diabetic retinopathy (DR) was found to be 34.6%. WHO estimates
that DR is responsible for 4.8% of the 37 million cases of blindness throughout the world.
Diabetic retinopathy (DR) is the fifth leading cause of visual impairment and the fourth
leading cause of blindness in the world (WHO, TADDS). In a study undertaken in an urban
population in Nepal, M.D.Bhattarai found the prevalence of diabetes among people aged 20
years and above to be 14.6% and the prevalence among people aged 40 years and above to be
19%. KAP study in Kathmandu revealed good knowledge, good attitude but poor practice among
the diabetic group. In contrast, the non-diabetic groups showed poor knowledge but a good
attitude and poor lifestyle practices. Hence diabetic group needs good practice like early
diagnosis of DR and self-care, and the non-diabetic group needs knowledge. Simply increasing
awareness among diabetic patients about the risk factors is not sufficient to improve
ophthalmic care. Various strategies will be necessary to improve good practice and patient
visits to an eye clinic on a regular basis.
Reiyukai Eiko Masunaga Eye Hospital (REMEH) was established in February 2007. REMEH is a
non-profitable organization. Approximately 411,057 populations of Kavrepalanchowk district
are the catchment area of REMEH. The REMEH hospital provided OPD service to 43,787 patients
in 2018 and 54,213 patients in 2019, performed 1,058 cataract surgeries in 2018 and 1,647 in
2019. Similarly, retina services were resumed from October 2019.
People are unaware of this new retinal service in the hospital. There was irregular retinal
service due to the lack of a vitreoretinal surgeon. But now there is regular medical as well
as surgical retina service. The unavailability of retina surgeons, low literacy rate and the
lack of awareness programs conducted in the community, costly retinal services, lack of
proper linkage to diabetic clinics and REMEH could be a reason for the low uptake of retina
services. The investigators would like to fill this gap and increase the uptake of this
retina sub-specialty focusing on Diabetes Mellitus to decrease blindness caused by Diabetic
Retinopathy by augmenting the referral pathway and declining the problem tree.
Methods:
This study is operational research that will take place in REMEH. The study design is a
non-randomized pre and post-intervention study design without a control group. The
intervention will consist of Health Education to specific health personnel who deal with DM
patients. A multi-specialty hospital named Scheer Memorial Hospital will be the intervention
hospital. Through the intervention, a referral pathway will be created to send the diabetes
patients for diabetic retinopathy screening to REMEH.
Research Objective:
Primary Objective: To provide health education intervention to selected health personnel and
establish a referral pathway.
Secondary Objective: To increase the attendance of patients with Diabetes Mellitus for
retinal screening at REMEH.
Details of the intervention hospital:
Scheer memorial hospital is a 150-bed hospital with daily 475 outpatient department patients.
It is located 1.8 km away from REMEH and has 223 staff.
Intervention:
Using the complete enumerations of all health personnel treating patients with diabetes,
below mentioned personnel will have more chances to interact with diabetic patients so only a
total of 19 health personnel will be chosen. They are 4 physicians, 4 pediatricians, 8
medical officers, and 3 assistants of Scheer Hospital.
Actions expected from selected health personnel in Scheer Memorial
1. Counsel DM patients to visit REMEH
2. Use referral slip while referring patients to REMEH
3. Handover DR-related pamphlet to DM patients.
1. Record total cases referred to REMEH in a month Depending on the feasibility, the Pilot
may be conducted with another group of doctors, to see if the materials are well understood
and the duration is optimal. A pilot test will help to see the smoothness of the sessions
conducted. Necessary modification in the PPT, method of training delivery if needed will be
done for the training sessions after the pilot Pilot visit: It will include the same IEC
materials used for intervention. PPT presentation by retina specialist with ample time to
answer queries. One short video display. Distribution of posters, pamphlets,
1. st visit: The information sheet with the consent form will be shared. The pre-test will
be done. PPT presentation by retina specialist with information on DR and importance of
the timely visit to screen eyes for DM patients will be presented. Distribution of
posters, pamphlets will be done.
2. nd visit: Two video presentations about Diabetic Retinopathy will be done. And posters
and pamphlets will be distributed.
3. rd visit: Refresher of previous sessions. A small quiz about the knowledge about DR
among the health personnel will be done and a post-test will be done about the acquired
knowledge.
Data collection:
Baseline data collection has been started from 1st June 2020 and has been continued till 25th
February 2021.
Time Management for the manuscript-
1. Preparation (three months: March 2020 to December 2020) The first 10 months will be used
for planning, proposal writing, and getting ethical approval from Nepal Health Research
Council. Scheer Memorial will be requested for approval of the study.
2. Pre-test and Intervention (February 2021 to April 2021) Baseline data will be collected
from June 1st to February 25th and the intervention started on 26th February 2021.
Initially, the Scheer Memorial hospital will be visited by the management team and the
procedure regarding the project will be explained including the patient referral
process. Similarly, a register will be maintained at REMEH to get demographic
information of each and every Diabetes Mellitus patient and information on the referral
physician/hospitals or self-referral visiting REMEH. Monthly data will be collected from
both the hospital regarding the number of patients referred for DR screening. Pretest to
see the smoothness of the training will be done and then monthly once visits will be
done at Scheer Memorial for intervention.
3. Data collection (Four months: May 2021 to July 2021) The data will be collected for
another three months ie: May to July 2021. Data on demographic detail of health
personnel, pre, and post-test scoring will be collected. Data on demographic details,
referral hospital, presence and stage of DR, visual outcome of patients will also be
collected.
4. Data analysis and Manuscript writing: (2 months: August- September 2021) The last 2
months August and September will be for data analysis and manuscript writing.
Study Subjects:
Target population: Health care personnel Study participants: Selected health care personnel
from Scheer Memorial Hospital hospital.
Sampling techniques: Complete enumerations of all health personnel treating diabetic
patients.
The procedure of Data Collection: Primary data collection will be done by a single person who
assists in OPD and who will be designated for data collection. The register will be
maintained at REMEH and monthly data on the number of DM patients referred for DR screening
will be collected from Scheer Memorial. These data will later be entered into Microsoft Excel
files or SPSS on weekly basis.
Project Strategies /Activities and patient pathway:
The study will be explained to Scheer Memorial Hospital
- Intervention in Scheer Memorial Hospital to do awareness campaigns and refer diabetic
patients to REMEH.
- The health personals will be acknowledged in the study.
- A referral slip/ written communication will be made and the referral process will be a
vice versa feedback process.
- Screening of all Diabetes patients will be done at REMEH by dilated fundus examination
under slit-lamp biomicroscopy.
- Dilated fundus examination of diabetic patients visiting the hospital will be done by
slit-lamp biomicroscopy.
When the participants enter REMEH for retinal services firstly the patient will be assessed.
The demographic data along with the referred physician or self-referral will be noted. It
will include history focused on diabetes and its modifiers. History of patients includes:
duration of diabetes, past glycemic control (hemoglobin A,1c), Medications (especially
insulin, oral hypoglycemic, anti-hypertensives, and lipid-lowering drugs), mention whether
simply diet control or herbal, systemic history (e.g., renal disease, systemic hypertension,
serum lipid levels, pregnancy, Anemia, Cardiac condition), ocular history smoking history and
contact information.
The screening will be made according to WHO tools for assessment of Diabetic Retinopathy.
Detailed patient assessment will include a complete ophthalmic examination, including visual
acuity and the identification and grading of severity of DR and presence of DME for each eye.
Physical examination of the eye will include: Visual acuity, measurement of intraocular
pressure (IOP), gonioscopy when indicated (e.g., when neovascularization of the iris is seen
or in eyes with increased IOP), slit-lamp bio-microscopy for anterior segment evaluation, and
fundus examination.
The follow-up will be scheduled according to the National Guidelines for Management of
Diabetic Retinopathy 2017.
Data entry and Analysis: Data entry and management will be done by the optometrist.
Statistical Package for the Social Sciences (SPSS) version 20 will be used in the end just
before project outcomes.
Ethical approvals: Ethical approval taken from Nepal Health Research Council (NHRC)
Discussion:
Our study is a non-randomized pre and post-intervention design which includes the
collaboration between an eye hospital and multi-specialty hospital focusing on the health
professional as a stakeholder to increase the referral of diabetic. The stakeholders will be
provided health education on awareness of diabetic retinopathy using PPTs, posters,
pamphlets, and referral slips. The outcome of the intervention will be assessed by a pre-and
post-evaluation questionnaire.
There are few studies similar to ours that have assessed the awareness of physicians by
calculating the Diabetic retinopathy awareness index. Anwar et al conducted a 27-item
consented & validated, multiple-choice questionnaire based on physician's characteristics,
knowledge, and practice of diabetic eye care and challenges faced due to the current DR
referral system in Pakistan.
The investigators will use a referral slip as a mode of communication between an
ophthalmologist and health care personnel with reference to the referral of diabetic
patients. Storey et al found that written communication between an ophthalmologist and a
primary care physician (PCP) and referral vice versa was effective to change the behavior of
the referring physicians. Riordan et al assessed that phone /letter reminder to patient and
provider level training increased diabetic screening. Printed educational messages or posters
also increased behavior and attitude change to primary care physicians.
Grimshaw et al also found that printed educational messages increased the number of referrals
by primary care physicians similar to our study where the investigators are using referral
slips to communicate between the ophthalmologist and health Health education intervention
could be a low-cost solution to improve the awareness, access, utilization of retinal health
care services; thus, health education intervention could reduce the burden of DR among people
with diabetes. However, this is an unexplored area in Nepal. Working closely with the
stakeholders, this study will evaluate the role of health education interventions (which are
already validated in other low-income settings) to reduce the burden of DR in Nepal.
Strength and Limitations:
The strength of our study is that it will be one of the first studies including stakeholders
to increase the attendance of diabetic retinopathy in Nepal. This helps to reduce the
unavoidable blindness caused by diabetic retinopathy.
