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临床试验/NCT03658980
NCT03658980已完成不适用

Integrating Diabetic Retinopathy Into Mainstream Health System in Bangladesh

Hiroshima University2 个研究点 分布在 1 个国家目标入组 299 人开始时间: 2018年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
299
试验地点
2
主要终点
Number of Participants Who Had Successful Referrals

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • atleast 18 years of age
  • Persons with diabetes who are registered with Barishal Diabetes Hospital
  • Referred to SBMC&H (tertiary hospital) for DR management (screening/treatment), from September 2017 - August 2018
  • Persons who did not undergo a Dilated Fundus Examination (DFE) in last 12 months
  • those who provide informed consent to be included in this study

排除标准

  • Below 18 years of age
  • Persons with diabetes who are registered with Barishal Diabetes Hospital but not referred to SBMC&H (tertiary hospital) for DR management
  • Persons with diabetes referred to SBMC&H before September 2017 or after August 2018
  • Persons who have undergone a Dilated Fundus Examination (DFE) in last 12 months
  • those who do not provide informed consent to be included in this study

研究组 & 干预措施

Health Education Intervention

Experimental

Face-to-face health education session on Diabetic Retinopathy and available services at a tertiary hospital, followed by telephonic reminders at Day 7, 30 and 90.

干预措施: Health Education Intervention (Behavioral)

Control Group

No Intervention

No Intervention will be conducted in this control group

结局指标

主要结局

Number of Participants Who Had Successful Referrals

时间窗: 5 months

Number of Participants Who Had 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

次要结局

  • Increase in Knowledge About Diabetic Retinopathy(5 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zara Khair

Principal Investigator

Hiroshima University

研究点 (2)

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