Randomized controlled trial evaluating an incentive-based community eye-care programme

• Register: ISRCTN
• Last refreshed on: 2 October 2017
• Main ID: ISRCTN23393504
• Date of registration: 25/08/2017
• Prospective Registration: No
• Primary sponsor: Singapore National Eye Centre
• Public title: Randomized controlled trial evaluating an incentive-based community eye-care programme
• Scientific title: Randomized controlled trial evaluating an incentive-based community eye-care programme for elderly with visual impairment
• Date of first enrolment: 01/06/2014
• Target sample size: 140
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN23393504
• Study type: Interventional
• Study design: Randomised controlled study (Quality of life)

Countries of recruitment

Singapore

Contacts

• Name: Anna Tan

Key inclusion & exclusion criteria

Inclusion criteria: 1. Over 21 years of age
2. The ability to speak English and/or Mandarin
3. Adequate hearing with/without hearing aids to respond to normal conversation
4. Not currently undergoing regular assessment/care with an ophthalmologist (at least yearly)
5. The ability to undergo visual acuity testing and provide reliable results
6. Visual acuity of 6/12 or worse in either eye after best correction
Exclusion criteria: Absence of the inclusion criteria and any other contraindication(s) as indicated by the general practitioner responsible for the participant

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Visual impairment
Eye Diseases
Visual impairment including blindness (binocular or monocular)

Intervention(s)

Eligible participants were approached for informed consent and after they agreed to participate, they were randomised into 2 arms with a 1:1 ratio, either in the intervention arm where they received the ICS or the UC arm. Randomisation was performed by a random allocation sequence that was generated by a computer with no blocks or restrictions, and implemented by concealing the number-coded treatment within sealed envelopes until just before the procedure. After a potential participant was enrolled by the investigators and had given informed consent, a research coordinator performed assigned the participants to their groups after opening the sealed envelope. Due to the nature of the intervention, participants and researchers were unable to be masked to group assignment.

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. A medical social worker was also involved for the suitability of continuing financial support for further follow-up under various government schemes.

Primary Outcome(s)

Uptake of tertiary referral, measured using attendance to tertiary hospital at 3 months

Secondary Outcome(s)

1. Visual acuity, measured on Snellen chart at 3 months
2. Vision-related quality of life (VRQoL), assessed using the 28-item Impact of Vision Impairment (IVI) questionnaire at baseline and at 3 months

Secondary ID(s)

R1102/4/2014

Source(s) of Monetary Support

Singapore National Eye Centre