<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03001258</url>
  </required_header>
  <id_info>
    <org_study_id>2015</org_study_id>
    <nct_id>NCT03001258</nct_id>
  </id_info>
  <brief_title>Presbyopia Screening by Community Health Worker in Bangladesh</brief_title>
  <official_title>Presbyopia Screening by Community Health Worker in Bangladesh: Implementation Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brac</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brac</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Demand in near vision correction in the community exist in the Bangladesh with a thin&#xD;
      presence of eye- care. This study aimed to test the skill of BRAC service-providers in&#xD;
      identifying presbyopia-cases, to ensure frequent services, meeting the community need. This&#xD;
      was non-inferiority equivalence randomized intervention trial, done during February-June&#xD;
      2015, in six randomly selected sub-districts, where 2059 camp-patients were screened. BRAC&#xD;
      Health-cadres; program organizers (PO), upgraded shasthya- shebikas (USS) and shasthya-&#xD;
      shebikas (SS), were assigned to three different arms consisting two sub-districts through&#xD;
      permuted-block randomization.105 eye-camps were organized with minimum 500 sample per arm.&#xD;
      Sensitivity and specificity was calculated to understand screening performance. Screening&#xD;
      reports were matched with the gold standard by recruiting refractionists.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study context:&#xD;
&#xD;
      In aligning with the significant unmet need of presbyopia and prevalent eye care scenario of&#xD;
      Bangladesh, BRAC- a multinational non-government organization (NGO), had been implementing a&#xD;
      project titled 'Reading glass for improved livelihood (RGIL)' to provide eye care service to&#xD;
      the people suffering from eye problems with special emphasis given to the near vision loss or&#xD;
      presbyopia since 2006. The objective of this project was to provide access to vision&#xD;
      screening and affordable eyeglasses to the people who combat diminished quality of life due&#xD;
      to blurry up-close vision and to extend referral for people with other eye problems.&#xD;
&#xD;
      BRAC's Health Nutrition and Population Program (HNPP) Division is implementing this project&#xD;
      in partnership with Vision Spring, USA. It has been an issue that whether program could use&#xD;
      its existing Community Health Workers (CHW), (BRAC designated them as shasthya shebikas, here&#xD;
      the investigators refer them as SS) instead of the assigned program organizers (BRAC&#xD;
      designated, the investigators refer them as PO) who had been doing the job, for conducting&#xD;
      screening and taking more leading role in selling glasses. In BRAC health program usually&#xD;
      these SSs are expected to work six days a week, spending two hours each day for the household&#xD;
      visits, covering around 250 Households (HHs) each month, and promote behaviour change&#xD;
      communication on various health components. SSs are non-salaried staff with lower educational&#xD;
      level, usually with eight years of schooling. During the initial stage on their job, they&#xD;
      receive 16 days of basic training on basic preventive, promotive and curative health care,&#xD;
      backed up by regular monthly refreshers training. POs usually had master level degree and&#xD;
      were regular salaried staff of BRAC as field level worker. When hired by BRAC, they receive a&#xD;
      six days basic health and management training to be able to work as a health worker in the&#xD;
      community. This change of role shifting, if adopted means that program can easily ensure&#xD;
      wider coverage within a short period as CHWs are more in numbers as well as have greater&#xD;
      access in the community. Moreover presbyopia can easily and effectively be corrected by&#xD;
      reading glasses and certified ophthalmologists are not necessarily required for the visual&#xD;
      correction; a lay person with low literacy and appropriate training can prescribe reading&#xD;
      glasses for the same. It was well-understood that organizing camp has its own limitation in&#xD;
      regards to its coverage of whole population on a regular basis. Moreover, in order to sustain&#xD;
      the reading glass program along with the camp, a system was warranted where trained workforce&#xD;
      could screen and suggest eye glass during their routine community visit. It was therefore, an&#xD;
      experimental study to assess the performance of different level of workforce to screen&#xD;
      presbyopia cases, which was necessary to bring in any changes in the service delivery model&#xD;
      to scale up throughout Bangladesh.&#xD;
&#xD;
      Eye camps were organized in each of the study sub-district with the aim to eliminate the&#xD;
      vision problem faced by the presbyopic patients. Potential patients were encouraged to join&#xD;
      camps and information on significance of the camp day, time and place of the camp, procedure&#xD;
      of patients' registration, brief of diagnostic techniques, benefits of estimating of&#xD;
      refractive error and offer to prescribe glasses only for presbyopia cases were largely&#xD;
      disseminated throughout the whole community. Refraction were undertaken using E charts by the&#xD;
      respective camp provider. Glasses were available to buy for the patients who required&#xD;
      spectacles with a cost of around 2 USD on the spot and providers were instructed to counsel&#xD;
      on glass use. These glasses were imported from the USA through Vision Spring, USA.&#xD;
&#xD;
      During the time of the intervention, USS were only employed in 20 sub districts where RGIL&#xD;
      was being implemented by BRAC HNPP. To ensure USS recruitment in the study the investigators&#xD;
      had to randomly select 6 sub-districts from these 20. Two sub districts were randomly&#xD;
      assigned to one of the three arms through permuted-block randomization. Community people aged&#xD;
      35 or more, both male or female and having difficulty with near vision were invited for&#xD;
      screening. Individuals having diagnosed eye diseases that require regular treatment and was&#xD;
      not willing to participate in the study were excluded.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      The sample sizes for this three-arm study were estimated using non-inferiority design. It was&#xD;
      assumed that true detection rate in the reference arm (refractionist) will be 80% and that in&#xD;
      the experimental arms would be identical. The investigators estimated that enrolment of 288&#xD;
      participants in each of the three arms with 2.5% one-sided significance level would yield 85%&#xD;
      power to demonstrate a similarity margin of -10%, if detection rates are identical. Assuming&#xD;
      a design effect of 1.5 for the cluster design, the investigators aimed to enrol 435&#xD;
      participants in each of the arms. For comparing accuracy rates between arms, required sample&#xD;
      size was 470 per arm to detect a 10% difference with 80% power, 5% significance level and 1.5&#xD;
      design effect. the investigators recruited a minimum of 500 per arm.&#xD;
&#xD;
      Data collection tools and techniques:&#xD;
&#xD;
      Both quantitative and qualitative data were collected for 2 weeks simultaneously face-to-face&#xD;
      from the respondents during the camp hours. For the quantitative data, two separate&#xD;
      closed-ended structured questionnaires were developed. Information regarding patient's&#xD;
      demographics and socio-economic status were collected. From the service providers,&#xD;
      information on their age, years of working with BRAC, and duration of involvement in BRAC's&#xD;
      RGIL project were also collected. Their level of knowledge was assessed and scored on several&#xD;
      issues for instance, common foreign body and infection related eye problems, and its&#xD;
      immediate measures, vision (either near or distance) related eye issues, presbyopia, it's&#xD;
      aetiology and certain eye conditions which would require to refer to registered eye&#xD;
      specialist. Furthermore, refractionists were present in each camp run by all three providers&#xD;
      in the respective arms. All the patients screened under any of the above three arms were then&#xD;
      re-examined by a refractionist to confirm the diagnosis of presbyopia and it was recorded in&#xD;
      a defined format. The investigators kept blinded each of the refractionists to the screening&#xD;
      outcome i.e. the refractionists were not aware of the screening report made by our service&#xD;
      providers prior to examining a patient. Background data were collected from presbyopia&#xD;
      positive participants only identified by BRAC workers. Data collection was performed by&#xD;
      skilled interviewers (consisting of science graduates having field experience). A five-day&#xD;
      intensive training was organized for them consisting of lectures, mock interviews, role play&#xD;
      and field practice in an eye camp. Before the actual survey, the teams were deployed in camps&#xD;
      and the participants were informed about the purpose of the study and with their informed&#xD;
      verbal consent, the interviewers took information on the camp day.&#xD;
&#xD;
      For the qualitative observation, the investigators recruited two anthropologists as research&#xD;
      assistant (RA) who had completed their undergraduate and masters on anthropology. who were&#xD;
      present during the entire camp hours run by three different service providers in three study&#xD;
      upazillas and observed the activities (from patients counselling to prescribing eye glass as&#xD;
      well as marketing aspects). A total of eight camps were observed in each provider arm in&#xD;
      three upazillas by two RA. There was one RA per camp who was assigned to observe two cases&#xD;
      and note the steps of the screening process for presbyopia by the BRAC providers and some key&#xD;
      features of the camp as per the camp protocol for example, counselling and marketing. The&#xD;
      qualitative data were collected using a semi structured observation checklist developed&#xD;
      following the presbyopia screening protocol and pretested prior to data collection. Observers&#xD;
      were given four days training including a one day practical observation exercise in an eye&#xD;
      screening camp on the relevant themes to be observed. A total of 24 cases were observed. The&#xD;
      investigators blinded the service providers from the direct observation by the research&#xD;
      assistants and it was possible because there were quantitative data collectors present in the&#xD;
      camp. Blinding was done to understand the unbiased performance by the intervention groups.&#xD;
      Content analysis was adopted to analyse the data according to predefined themes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Screening Accuracy</measure>
    <time_frame>The study duration was for 5 months, however, data was collected by organizing the eye camps over 2 weeks period</time_frame>
    <description>The outcome was considered as accurate and coded as &quot;1&quot; 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.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">2001</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>PO (program organizers)</arm_group_label>
    <description>PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>USS (Upgraded Shashthya Shebika)</arm_group_label>
    <description>USS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SS (Shashthya Shebika)</arm_group_label>
    <description>SS: Community health workers of Brac. A two day presbyopia screening training were provided.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Presbyopia screening training</intervention_name>
    <description>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</description>
    <arm_group_label>PO (program organizers)</arm_group_label>
    <arm_group_label>SS (Shashthya Shebika)</arm_group_label>
    <arm_group_label>USS (Upgraded Shashthya Shebika)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Community people aged 35 or more, both male or female and having difficulty with near&#xD;
        vision were invited for screening.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 35 or more and have problem seeing close objects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals having diagnosed eye diseases that require regular treatment and was not&#xD;
             willing to participate in the study were excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anita Chowdhury, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brac</affiliation>
  </overall_official>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <results_first_submitted>January 3, 2017</results_first_submitted>
  <results_first_submitted_qc>March 11, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 21, 2017</results_first_posted>
  <last_update_submitted>March 11, 2017</last_update_submitted>
  <last_update_submitted_qc>March 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brac</investigator_affiliation>
    <investigator_full_name>Anita Sharif Chowdhury</investigator_full_name>
    <investigator_title>Research Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Presbyopia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>PO (Program Organizers)</title>
          <description>PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided.&#xD;
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. A total of 40 eye camps were held in two sub districts by eight POs.&#xD;
Presbyopia screening training: 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 managemen</description>
        </group>
        <group group_id="P2">
          <title>USS (Upgraded Shashthya Shebika)</title>
          <description>USS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided.&#xD;
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.&#xD;
Presbyopia screening training: 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</description>
        </group>
        <group group_id="P3">
          <title>SS (Shashthya Shebika)</title>
          <description>SS: Community health workers of Brac. A two day presbyopia screening training were provided.&#xD;
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.&#xD;
Presbyopia screening training: 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</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="765"/>
                <participants group_id="P2" count="751"/>
                <participants group_id="P3" count="485"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="765"/>
                <participants group_id="P2" count="751"/>
                <participants group_id="P3" count="485"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The discrepancy in the sample size (2001 vs 1090) was because we did two separate sample size calculation in this study. Firstly, in the intervention trial for 3 arms, our sample size was 2001. Then, we took sub-sample (1090) from the intervention sample (2001) to capture patients' socio-demographics.</population>
      <group_list>
        <group group_id="B1">
          <title>PO (Program Organizers)</title>
          <description>PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. 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.&#xD;
A total of 40 eye camps were held in two sub districts by eight POs.</description>
        </group>
        <group group_id="B2">
          <title>USS (Upgraded Shashthya Shebika)</title>
          <description>USS (Upgraded Shashthya Shebika): A new cadre of community health workers of Brac. A two day presbyopia screening training were provided.&#xD;
20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the camps.&#xD;
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.</description>
        </group>
        <group group_id="B3">
          <title>SS (Shashthya Shebika)</title>
          <description>SS: Community health workers of Brac. A two day presbyopia screening training were provided.&#xD;
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.&#xD;
Presbyopia screening training: 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</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="400"/>
            <count group_id="B2" value="440"/>
            <count group_id="B3" value="250"/>
            <count group_id="B4" value="1090"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <population>It is distribution of total population by customized age catagory</population>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="45"/>
                    <count group_id="B4" value="169"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40-44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="126"/>
                    <count group_id="B2" value="146"/>
                    <count group_id="B3" value="52"/>
                    <count group_id="B4" value="324"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="126"/>
                    <measurement group_id="B2" value="146"/>
                    <measurement group_id="B3" value="52"/>
                    <measurement group_id="B4" value="324"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45-49</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                    <count group_id="B2" value="108"/>
                    <count group_id="B3" value="65"/>
                    <count group_id="B4" value="261"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="65"/>
                    <measurement group_id="B4" value="261"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50-54</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="67"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="47"/>
                    <count group_id="B4" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 55</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                    <count group_id="B2" value="62"/>
                    <count group_id="B3" value="41"/>
                    <count group_id="B4" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                    <count group_id="B2" value="440"/>
                    <count group_id="B3" value="250"/>
                    <count group_id="B4" value="1090"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="314"/>
                    <measurement group_id="B2" value="385"/>
                    <measurement group_id="B3" value="214"/>
                    <measurement group_id="B4" value="913"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Screening Accuracy</title>
        <description>The outcome was considered as accurate and coded as &quot;1&quot; 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.</description>
        <time_frame>The study duration was for 5 months, however, data was collected by organizing the eye camps over 2 weeks period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PO (Program Organizers)</title>
            <description>PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. 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. A total of 40 eye camps were held in two sub districts by eight POs.</description>
          </group>
          <group group_id="O2">
            <title>USS (Upgraded Shashthya Shebika)</title>
            <description>USS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided.&#xD;
20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the eye camps.&#xD;
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</description>
          </group>
          <group group_id="O3">
            <title>SS (Shashthya Shebika)</title>
            <description>SS: Community health workers of Brac. A two day presbyopia screening training were provided.&#xD;
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.&#xD;
Presbyopia screening training: 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</description>
          </group>
        </group_list>
        <measure>
          <title>Screening Accuracy</title>
          <description>The outcome was considered as accurate and coded as &quot;1&quot; 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.</description>
          <units>percentage of cases</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="765"/>
                <count group_id="O2" value="751"/>
                <count group_id="O3" value="485"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sensitivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.9" lower_limit="72.6" upper_limit="80.8"/>
                    <measurement group_id="O2" value="75.7" lower_limit="71.8" upper_limit="79.3"/>
                    <measurement group_id="O3" value="58.1" lower_limit="52.8" upper_limit="63.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specificity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.3" lower_limit="73.5" upper_limit="82.6"/>
                    <measurement group_id="O2" value="67.0" lower_limit="60.3" upper_limit="73.1"/>
                    <measurement group_id="O3" value="69.3" lower_limit="60.5" upper_limit="77.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive Predictive Value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.5" lower_limit="77.3" upper_limit="85.2"/>
                    <measurement group_id="O2" value="84.6" lower_limit="81.0" upper_limit="87.7"/>
                    <measurement group_id="O3" value="84.2" lower_limit="79.1" upper_limit="88.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative Predictive Value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.2" lower_limit="68.3" upper_limit="77.6"/>
                    <measurement group_id="O2" value="53.4" lower_limit="47.4" upper_limit="59.4"/>
                    <measurement group_id="O3" value="84.2" lower_limit="79.1" upper_limit="88.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Accuracy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.5" lower_limit="74.4" upper_limit="80.3"/>
                    <measurement group_id="O2" value="73.1" lower_limit="69.8" upper_limit="76.2"/>
                    <measurement group_id="O3" value="61.0" lower_limit="56.6" upper_limit="65.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>False Positive Rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1" lower_limit="19.4" upper_limit="27.4"/>
                    <measurement group_id="O2" value="24.3" lower_limit="20.9" upper_limit="28.2"/>
                    <measurement group_id="O3" value="41.9" lower_limit="36.9" upper_limit="47.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>False Negative Rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7" lower_limit="17.7" upper_limit="26.4"/>
                    <measurement group_id="O2" value="33.0" lower_limit="27.2" upper_limit="39.5"/>
                    <measurement group_id="O3" value="30.7" lower_limit="23.4" upper_limit="39.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>PO (Program Organizers)</title>
          <description>PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. 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 A total of 40 eye camps were held in two sub districts by eight POs.</description>
        </group>
        <group group_id="E2">
          <title>USS (Upgraded Shashthya Shebika)</title>
          <description>USS (Upgraded Shashthya Shebika): A new cadre of community health workers of Brac. A two day presbyopia screening training were provided.&#xD;
20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the eye camps.&#xD;
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</description>
        </group>
        <group group_id="E3">
          <title>SS (Shashthya Shebika)</title>
          <description>SS: Community health workers of Brac. A two day presbyopia screening training were provided.&#xD;
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.&#xD;
Presbyopia screening training: 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</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="00" subjects_at_risk="00"/>
                <counts group_id="E2" subjects_affected="00" subjects_at_risk="00"/>
                <counts group_id="E3" subjects_affected="00" subjects_at_risk="00"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Anita Sharif Chowdhury/Research Fellow of BRAC Research and Evaluation Division</name_or_title>
      <organization>BRAC</organization>
      <phone>+88029846448 ext 3719</phone>
      <email>anita.sc@brac.net</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03001258
org study id: 2015
nct id: NCT03001258
lead sponsor: 
has dmc: No
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.
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.
observational model: Ecologic or Community
time perspective: Cross-Sectional
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
description: 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.
arm group label: PO (program organizers)
description: 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.
arm group label: USS (Upgraded Shashthya Shebika)
description: 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.
arm group label: SS (Shashthya Shebika)
description: 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.
intervention type: Other
intervention name: Presbyopia screening training
description: 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
arm group label: PO (program organizers)
arm group label: SS (Shashthya Shebika)
arm group label: USS (Upgraded Shashthya Shebika)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anita Chowdhury, MPH
role: Principal Investigator
affiliation: Brac
responsible party type: Principal Investigator
investigator affiliation: Brac
investigator full name: Anita Sharif Chowdhury
investigator title: Research Fellow
mesh term: Presbyopia
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 