<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/NCT03264885</url>
  </required_header>
  <id_info>
    <org_study_id>R1102/4/2014</org_study_id>
    <nct_id>NCT03264885</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trial Evaluating an Incentive-based Community Eye-care Programme</brief_title>
  <official_title>Randomized Controlled Trial Evaluating an Incentive-based Community Eye-care Programme for Elderly With Visual Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Singapore National Eye Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Singapore National Eye Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Elderly with visual impairment (VI) who undergo community eye screening often do not attend&#xD;
      tertiary follow-up even if significant eye diseases are detected. Investigators evaluate an&#xD;
      incentive-care scheme (ICS) to improve the attendance rates of tertiary eye-care visits of&#xD;
      participants following community eye screening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled study individuals with VI with baseline visual acuity (VA) and&#xD;
      vision-related quality of life (VRQoL) assessed in the community. Participants were&#xD;
      randomised to either receiving ICS or usual care (UC). ICS is a novel intervention that&#xD;
      incorporates patient education, social support, and financial assistance to assist&#xD;
      individuals. Participants in UC received a standard GP referral letter advising them to seek&#xD;
      further care. Our main outcome measure was compliance to tertiary eye-care referral. Our&#xD;
      secondary outcome measure was VA and VRQoL assessed at 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance to Tertiary Care Follow-up</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of participants who attended follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>3 months</time_frame>
    <description>Vision checked on Snellen chart</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Visual Impairment</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The usual stand of care (UC) after community eye screening was to provide a GP referral letter and advice to attend a tertiary eye care facility most accessible to them</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Incentive Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In addition to the UC, those assigned to the ICS also received social and financial support to incentivise and improve compliance. All ICS participants were assisted with scheduling their tertiary care appointments, given telephone reminders, provided once-off transportation allowance and subsidy for their first tertiary eye-care consultation - while participants with mobility issues were assisted by volunteers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Incentive Care</intervention_name>
    <description>ICS is a novel intervention that incorporates patient education, social support, and financial assistance to assist individuals.</description>
    <arm_group_label>Incentive Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the ability to speak English and/or Mandarin, have adequate hearing with/without&#xD;
             hearing aids to respond to normal conversation, not currently undergoing regular&#xD;
             assessment/care with an ophthalmologist (at least yearly), have the ability to undergo&#xD;
             visual acuity testing and provide reliable results, and visual acuity of 6/12 or worse&#xD;
             in either eye after best correction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refused informed consent and any other contraindication(s) as indicated by the general&#xD;
             practitioner responsible for the participant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcus Ang</last_name>
    <role>Principal Investigator</role>
    <affiliation>SNEC</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vision Disorders</mesh_term>
    <mesh_term>Vision, Low</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will not be available to other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03264885
org study id: R1102/4/2014
nct id: NCT03264885
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Elderly with visual impairment (VI) who undergo community eye screening often do not attend
      tertiary follow-up even if significant eye diseases are detected. Investigators evaluate an
      incentive-care scheme (ICS) to improve the attendance rates of tertiary eye-care visits of
      participants following community eye screening.
A randomized controlled study individuals with VI with baseline visual acuity (VA) and
      vision-related quality of life (VRQoL) assessed in the community. Participants were
      randomised to either receiving ICS or usual care (UC). ICS is a novel intervention that
      incorporates patient education, social support, and financial assistance to assist
      individuals. Participants in UC received a standard GP referral letter advising them to seek
      further care. Our main outcome measure was compliance to tertiary eye-care referral. Our
      secondary outcome measure was VA and VRQoL assessed at 3 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Compliance to Tertiary Care Follow-up
time frame: 3 months
description: Percentage of participants who attended follow-up
measure: Visual Acuity
time frame: 3 months
description: Vision checked on Snellen chart
arm group label: Usual Care
arm group type: No Intervention
description: The usual stand of care (UC) after community eye screening was to provide a GP referral letter and advice to attend a tertiary eye care facility most accessible to them
arm group label: Incentive Care
arm group type: Other
description: In addition to the UC, those assigned to the ICS also received social and financial support to incentivise and improve compliance. All ICS participants were assisted with scheduling their tertiary care appointments, given telephone reminders, provided once-off transportation allowance and subsidy for their first tertiary eye-care consultation - while participants with mobility issues were assisted by volunteers.
intervention type: Other
intervention name: Incentive Care
description: ICS is a novel intervention that incorporates patient education, social support, and financial assistance to assist individuals.
arm group label: Incentive Care
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marcus Ang
role: Principal Investigator
affiliation: SNEC
responsible party type: Sponsor
mesh term: Vision Disorders
mesh term: Vision, Low
sharing ipd: No
ipd description: Data will not be available to other researchers