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临床试验/NCT03001258
NCT03001258已完成不适用

Presbyopia Screening by Community Health Worker in Bangladesh: Implementation Research

Brac0 个研究点目标入组 2,001 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Brac
入组人数
2,001
主要终点
Screening Accuracy

研究概览

简要总结

Demand in near vision correction in the community exist in the Bangladesh with a thin presence of eye- care. This study aimed to test the skill of BRAC service-providers in identifying presbyopia-cases, to ensure frequent services, meeting the community need. This was non-inferiority equivalence randomized intervention trial, done during February-June 2015, in six randomly selected sub-districts, where 2059 camp-patients were screened. BRAC Health-cadres; program organizers (PO), upgraded shasthya- shebikas (USS) and shasthya- shebikas (SS), were assigned to three different arms consisting two sub-districts through permuted-block randomization.105 eye-camps were organized with minimum 500 sample per arm. Sensitivity and specificity was calculated to understand screening performance. Screening reports were matched with the gold standard by recruiting refractionists.

详细描述

Study context:

In aligning with the significant unmet need of presbyopia and prevalent eye care scenario of Bangladesh, BRAC- a multinational non-government organization (NGO), had been implementing a project titled 'Reading glass for improved livelihood (RGIL)' to provide eye care service to the people suffering from eye problems with special emphasis given to the near vision loss or presbyopia since 2006. The objective of this project was to provide access to vision screening and affordable eyeglasses to the people who combat diminished quality of life due to blurry up-close vision and to extend referral for people with other eye problems.

BRAC's Health Nutrition and Population Program (HNPP) Division is implementing this project in partnership with Vision Spring, USA. It has been an issue that whether program could use its existing Community Health Workers (CHW), (BRAC designated them as shasthya shebikas, here the investigators refer them as SS) instead of the assigned program organizers (BRAC designated, the investigators refer them as PO) who had been doing the job, for conducting screening and taking more leading role in selling glasses. In BRAC health program usually these SSs are expected to work six days a week, spending two hours each day for the household visits, covering around 250 Households (HHs) each month, and promote behaviour change communication on various health components. SSs are non-salaried staff with lower educational level, usually with eight years of schooling. During the initial stage on their job, they receive 16 days of basic training on basic preventive, promotive and curative health care, backed up by regular monthly refreshers training. POs usually had master level degree and were regular salaried staff of BRAC as field level worker. When hired by BRAC, they receive a six days basic health and management training to be able to work as a health worker in the community. This change of role shifting, if adopted means that program can easily ensure wider coverage within a short period as CHWs are more in numbers as well as have greater access in the community. Moreover presbyopia can easily and effectively be corrected by reading glasses and certified ophthalmologists are not necessarily required for the visual correction; a lay person with low literacy and appropriate training can prescribe reading glasses for the same. It was well-understood that organizing camp has its own limitation in regards to its coverage of whole population on a regular basis. Moreover, in order to sustain the reading glass program along with the camp, a system was warranted where trained workforce could screen and suggest eye glass during their routine community visit. It was therefore, an experimental study to assess the performance of different level of workforce to screen presbyopia cases, which was necessary to bring in any changes in the service delivery model to scale up throughout Bangladesh.

Eye camps were organized in each of the study sub-district with the aim to eliminate the vision problem faced by the presbyopic patients. Potential patients were encouraged to join camps and information on significance of the camp day, time and place of the camp, procedure of patients' registration, brief of diagnostic techniques, benefits of estimating of refractive error and offer to prescribe glasses only for presbyopia cases were largely disseminated throughout the whole community. Refraction were undertaken using E charts by the respective camp provider. Glasses were available to buy for the patients who required spectacles with a cost of around 2 USD on the spot and providers were instructed to counsel on glass use. These glasses were imported from the USA through Vision Spring, USA.

During the time of the intervention, USS were only employed in 20 sub districts where RGIL was being implemented by BRAC HNPP. To ensure USS recruitment in the study the investigators had to randomly select 6 sub-districts from these 20. Two sub districts were randomly assigned to one of the three arms through permuted-block randomization. Community people aged 35 or more, both male or female and having difficulty with near vision were invited for screening. Individuals having diagnosed eye diseases that require regular treatment and was not willing to participate in the study were excluded.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 35 or more and have problem seeing close objects

排除标准

  • Individuals having diagnosed eye diseases that require regular treatment and was not willing to participate in the study were excluded

结局指标

主要结局

Screening Accuracy

时间窗: The study duration was for 5 months, however, data was collected by organizing the eye camps over 2 weeks period

The outcome was considered as accurate and coded as "1" if the screening result agreed with the gold standard. That is, if the screening result is positive for presbyopia and the refractionist also reported it as positive or the screening result is negative and the refractionist also reported as negative.

次要结局

未报告次要终点

研究者

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

Anita Sharif Chowdhury

Research Fellow

Brac

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