PresbyopiaNCT03001258
Presbyopia Screening by Community Health Worker in Bangladesh
An observational study of Presbyopia, run by Brac.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- Presbyopia screening training
- How many people
- 2,001 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jun 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community people aged 35 or more, both male or female and having difficulty with near vision were invited for screening.
Who may be able to join
- Aged 35 or more and have problem seeing close objects
Who cannot join
- Individuals having diagnosed eye diseases that require regular treatment and was not willing to participate in the study were excluded
About this study
Official title: Presbyopia Screening by Community Health Worker in Bangladesh: Implementation Research
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.
Read the detailed description
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.
Sample size:
The sample sizes for this three-arm study were estimated using non-inferiority design. It was assumed that true detection rate in the reference arm (refractionist) will be 80% and that in the experimental arms would be identical. The investigators estimated that enrolment of 288 participants in each of the three arms with 2.5% one-sided significance level would yield 85% power to demonstrate a similarity margin of -10%, if detection rates are identical. Assuming a design effect of 1.5 for the cluster design, the investigators aimed to enrol 435 participants in each of the arms. For comparing accuracy rates between arms, required sample size was 470 per arm to detect a 10% difference with 80% power, 5% significance level and 1.5 design effect. the investigators recruited a minimum of 500 per arm.
Data collection tools and techniques:
Both quantitative and qualitative data were collected for 2 weeks simultaneously face-to-face from the respondents during the camp hours. For the quantitative data, two separate closed-ended structured questionnaires were developed. Information regarding patient's demographics and socio-economic status were collected. From the service providers, information on their age, years of working with BRAC, and duration of involvement in BRAC's RGIL project were also collected. Their level of knowledge was assessed and scored on several issues for instance, common foreign body and infection related eye problems, and its immediate measures, vision (either near or distance) related eye issues, presbyopia, it's aetiology and certain eye conditions which would require to refer to registered eye specialist. Furthermore, refractionists were present in each camp run by all three providers in the respective arms. All the patients screened under any of the above three arms were then re-examined by a refractionist to confirm the diagnosis of presbyopia and it was recorded in a defined format. The investigators kept blinded each of the refractionists to the screening outcome i.e. the refractionists were not aware of the screening report made by our service providers prior to examining a patient. Background data were collected from presbyopia positive participants only identified by BRAC workers. Data collection was performed by skilled interviewers (consisting of science graduates having field experience). A five-day intensive training was organized for them consisting of lectures, mock interviews, role play and field practice in an eye camp. Before the actual survey, the teams were deployed in camps and the participants were informed about the purpose of the study and with their informed verbal consent, the interviewers took information on the camp day.
For the qualitative observation, the investigators recruited two anthropologists as research assistant (RA) who had completed their undergraduate and masters on anthropology. who were present during the entire camp hours run by three different service providers in three study upazillas and observed the activities (from patients counselling to prescribing eye glass as well as marketing aspects). A total of eight camps were observed in each provider arm in three upazillas by two RA. There was one RA per camp who was assigned to observe two cases and note the steps of the screening process for presbyopia by the BRAC providers and some key features of the camp as per the camp protocol for example, counselling and marketing. The qualitative data were collected using a semi structured observation checklist developed following the presbyopia screening protocol and pretested prior to data collection. Observers were given four days training including a one day practical observation exercise in an eye screening camp on the relevant themes to be observed. A total of 24 cases were observed. The investigators blinded the service providers from the direct observation by the research assistants and it was possible because there were quantitative data collectors present in the camp. Blinding was done to understand the unbiased performance by the intervention groups. Content analysis was adopted to analyse the data according to predefined themes.
- Conditions
- Presbyopia
- Being tested
- Presbyopia screening training
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presbyopia screening trainingOther
The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity
| Study group | Role | What they receive |
|---|---|---|
| PO (program organizers) | PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided.
A total of eight POs organized eye camps in two sub districts. POs were responsible for identifying the presbyopia patients through screening and SS assisted in organizing and mobilizing the community people for the eye camps, and glass sale (on the spot). Four camps were organized per day for five days by four POs in each sub-district. Thus a total of 40 eye camps were held in two sub districts by eight POs. Receives: Other: Presbyopia screening training | |
| USS (Upgraded Shashthya Shebika) | USS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided.
In this arm, 20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the total 40 eye camps. Receives: Other: Presbyopia screening training | |
| SS (Shashthya Shebika) | SS: Community health workers of Brac. A two day presbyopia screening training were provided.
In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas. Receives: Other: Presbyopia screening training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening Accuracy
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.
Measured: The study duration was for 5 months, however, data was collected by organizing the eye camps over 2 weeks period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brac
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anita Sharif Chowdhury, Brac
- Investigators
- Anita Chowdhury, MPH, Principal investigator, Brac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001258
- Sponsor's protocol ID
- 2015
- Status last verified
- Mar 2017
- First submitted
- 16 Dec 2016
- Last updated
- 21 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presbyopia Screening by Community Health Worker in Bangladesh: Implementation Research
- ClinicalTrials.gov ID
- NCT03001258
- Acronym / sponsor ID
- 2015
- Conditions
- Presbyopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,001 participants (actual)
- Lead sponsor
- BracUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Posted 21 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Sample size:
The sample sizes for this three-arm study were estimated using non-inferiority design. It was assumed that true detection rate in the reference arm (refractionist) will be 80% and that in the experimental arms would be identical. The investigators estimated that enrolment of 288 participants in each of the three arms with 2.5% one-sided significance level would yield 85% power to demonstrate a similarity margin of -10%, if detection rates are identical. Assuming a design effect of 1.5 for the cluster design, the investigators aimed to enrol 435 participants in each of the arms. For comparing accuracy rates between arms, required sample size was 470 per arm to detect a 10% difference with 80% power, 5% significance level and 1.5 design effect. the investigators recruited a minimum of 500 per arm.
Data collection tools and techniques:
Both quantitative and qualitative data were collected for 2 weeks simultaneously face-to-face from the respondents during the camp hours. For the quantitative data, two separate closed-ended structured questionnaires were developed. Information regarding patient's demographics and socio-economic status were collected. From the service providers, information on their age, years of working with BRAC, and duration of involvement in BRAC's RGIL project were also collected. Their level of knowledge was assessed and scored on several issues for instance, common foreign body and infection related eye problems, and its immediate measures, vision (either near or distance) related eye issues, presbyopia, it's aetiology and certain eye conditions which would require to refer to registered eye specialist. Furthermore, refractionists were present in each camp run by all three providers in the respective arms. All the patients screened under any of the above three arms were then re-examined by a refractionist to confirm the diagnosis of presbyopia and it was recorded in a defined format. The investigators kept blinded each of the refractionists to the screening outcome i.e. the refractionists were not aware of the screening report made by our service providers prior to examining a patient. Background data were collected from presbyopia positive participants only identified by BRAC workers. Data collection was performed by skilled interviewers (consisting of science graduates having field experience). A five-day intensive training was organized for them consisting of lectures, mock interviews, role play and field practice in an eye camp. Before the actual survey, the teams were deployed in camps and the participants were informed about the purpose of the study and with their informed verbal consent, the interviewers took information on the camp day.
For the qualitative observation, the investigators recruited two anthropologists as research assistant (RA) who had completed their undergraduate and masters on anthropology. who were present during the entire camp hours run by three different service providers in three study upazillas and observed the activities (from patients counselling to prescribing eye glass as well as marketing aspects). A total of eight camps were observed in each provider arm in three upazillas by two RA. There was one RA per camp who was assigned to observe two cases and note the steps of the screening process for presbyopia by the BRAC providers and some key features of the camp as per the camp protocol for example, counselling and marketing. The qualitative data were collected using a semi structured observation checklist developed following the presbyopia screening protocol and pretested prior to data collection. Observers were given four days training including a one day practical observation exercise in an eye screening camp on the relevant themes to be observed. A total of 24 cases were observed. The investigators blinded the service providers from the direct observation by the research assistants and it was possible because there were quantitative data collectors present in the camp. Blinding was done to understand the unbiased performance by the intervention groups. Content analysis was adopted to analyse the data according to predefined themes.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PO (program organizers) | – | Other: Presbyopia screening trainingPO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. A total of eight POs organized eye camps in two sub districts. POs were responsible for identifying the presbyopia patients through screening and SS assisted in organizing and mobilizing the community people for the eye camps, and glass sale (on the spot). Four camps were organized per day for five days by four POs in each sub-district. Thus a total of 40 eye camps were held in two sub districts by eight POs. |
| USS (Upgraded Shashthya Shebika) | – | Other: Presbyopia screening trainingUSS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided. In this arm, 20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the total 40 eye camps. |
| SS (Shashthya Shebika) | – | Other: Presbyopia screening trainingSS: Community health workers of Brac. A two day presbyopia screening training were provided. In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community people aged 35 or more, both male or female and having difficulty with near vision were invited for screening.
Key inclusion criteria (1 listed)
- Aged 35 or more and have problem seeing close objects
Key exclusion criteria (1 listed)
- Individuals having diagnosed eye diseases that require regular treatment and was not willing to participate in the study were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Presbyopia screening trainingThe training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity | Other | PO (program organizers), SS (Shashthya Shebika), USS (Upgraded Shashthya Shebika) |
Primary outcome
Screening Accuracy
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Chowdhury, MPH principal investigator
Brac
Questions about this trial
What is this clinical trial studying?
An observational study of Presbyopia, run by Brac.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening Accuracy (time frame: The study duration was for 5 months, however, data was collected by organizing the eye camps over 2 weeks period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.