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
About this trial
This is an interventional health services research trial for Visual Impairment
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
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
NCT ID
NCT03264885
First Posted
August 24, 2017
Last Updated
September 25, 2019
Sponsor
Singapore National Eye Centre
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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