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CompletedNCT03264885Updated Sep 26, 2019

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

An interventional study of Incentive Care in Visual Impairment, sponsored by Singapore National Eye Centre. Completed. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-26.

Sponsored by Singapore National Eye Centre · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Visual Impairment
03

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • refused informed consent and any other contraindication(s) as indicated by the general practitioner responsible for the participant
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • No intervention
    Usual Care

    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

  • Other
    Incentive Care

    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.

    Other: Incentive Care

Interventions

  • OtherIncentive Care

    ICS is a novel intervention that incorporates patient education, social support, and financial assistance to assist individuals.

05

What researchers measure

Primary outcomes

  1. Compliance to Tertiary Care Follow-up

    Percentage of participants who attended follow-up

    Time frame: 3 months

Secondary outcomes

  1. Visual Acuity

    Vision checked on Snellen chart

    Time frame: 3 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No — Data will not be available to other researchers

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03264885
Lead sponsor
Singapore National Eye Centre
Responsible party
Sponsor
First posted
Aug 29, 2017
Start date
Jan 1, 2014
Primary completion
Jan 1, 2017
Completion
Jan 1, 2018
Last update
Sep 26, 2019

Study contacts

Marcus Ang
principal investigator · SNEC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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