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

Randomized Controlled Trial Evaluating an Incentive-based Community Eye-care Programme for Elderly With Visual Impairment

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.

Study Overview

• Status: Completed
• Conditions: Visual Impairment
• Intervention / Treatment: Other: Incentive Care

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; ICS is a novel intervention that incorporates patient education, social support, and financial assistance to assist individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance to Tertiary Care Follow-up	Percentage of participants who attended follow-up	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Vision checked on Snellen chart	3 months

Collaborators and Investigators

• Sponsor: Singapore National Eye Centre
• Investigators: Principal Investigator: Marcus Ang, SNEC

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (ACTUAL): August 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision, Low; Vision Disorders
• Other Study ID Numbers: R1102/4/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No