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Randomized Controlled Trial Evaluating an Incentive-based Community Eye-care Programme

Primary Purpose

Visual Impairment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Incentive Care
Sponsored by
Singapore National Eye Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Visual Impairment

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • the ability to speak English and/or Mandarin, have adequate hearing with/without hearing aids to respond to normal conversation, not currently undergoing regular assessment/care with an ophthalmologist (at least yearly), have the ability to undergo visual acuity testing and provide reliable results, and visual acuity of 6/12 or worse in either eye after best correction

Exclusion Criteria:

  • refused informed consent and any other contraindication(s) as indicated by the general practitioner responsible for the participant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Other

    Arm Label

    Usual Care

    Incentive Care

    Arm 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

    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.

    Outcomes

    Primary Outcome Measures

    Compliance to Tertiary Care Follow-up
    Percentage of participants who attended follow-up

    Secondary Outcome Measures

    Visual Acuity
    Vision checked on Snellen chart

    Full Information

    First Posted
    August 24, 2017
    Last Updated
    September 25, 2019
    Sponsor
    Singapore National Eye Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03264885
    Brief Title
    Randomized Controlled Trial Evaluating an Incentive-based Community Eye-care Programme
    Official Title
    Randomized Controlled Trial Evaluating an Incentive-based Community Eye-care Programme for Elderly With Visual Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    January 1, 2017 (Actual)
    Study Completion Date
    January 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Singapore National Eye Centre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Visual Impairment

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm 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 Title
    Incentive Care
    Arm Type
    Other
    Arm 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(s)
    Incentive Care
    Intervention Description
    ICS is a novel intervention that incorporates patient education, social support, and financial assistance to assist individuals.
    Primary Outcome Measure Information:
    Title
    Compliance to Tertiary Care Follow-up
    Description
    Percentage of participants who attended follow-up
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Visual Acuity
    Description
    Vision checked on Snellen chart
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: the ability to speak English and/or Mandarin, have adequate hearing with/without hearing aids to respond to normal conversation, not currently undergoing regular assessment/care with an ophthalmologist (at least yearly), have the ability to undergo visual acuity testing and provide reliable results, and visual acuity of 6/12 or worse in either eye after best correction Exclusion Criteria: refused informed consent and any other contraindication(s) as indicated by the general practitioner responsible for the participant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marcus Ang
    Organizational Affiliation
    SNEC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data will not be available to other researchers

    Learn more about this trial

    Randomized Controlled Trial Evaluating an Incentive-based Community Eye-care Programme

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