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

ISRCTN ISRCTN23393504
DOI https://doi.org/10.1186/ISRCTN23393504
Secondary identifying numbers R1102/4/2014
Submission date
23/08/2017
Registration date
25/08/2017
Last edited
25/08/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
People with visual impairment who undergo community eye screening often do not attend tertiary follow-up even if significant eye diseases are detected. The aim of this study is to assess an incentive-care scheme (ICS) to improve the attendance rates of tertiary eye-care visits following community eye screening.

Who can participate?
Patients aged over 21 with visual impairment

What does the study involve?
Participants are randomly allocated into two groups. One group receives the usual care after community eye screening - a GP referral letter and advice to attend the tertiary eye care facility most accessible to them. The other group receives the usual care and also the ICS, which involves patient education, social support and financial assistance. ICS participants are assisted with scheduling their tertiary care appointments, given telephone reminders, and provided with a one-off transportation allowance and subsidy for their first tertiary eye-care consultation, and participants with mobility issues are assisted by volunteers. A medical social worker is also involved for continuing financial support for further follow-up under various government schemes. Participants’ uptake of tertiary referral is measured using attendance to tertiary hospital after 3 months.

What are the possible benefits and risks of participating?
Participants receive tertiary eyecare with financial assistance. There are no risks involved.

Where is the study run from?
Singapore National Eye Centre

When is the study starting and how long is it expected to run for?
January 2012 to January 2017

Who is funding the study?
Singapore National Eye Centre

Who is the main contact?
Dr Anna Tan

Contact information

Dr Anna Tan
Public

11 Third Hospital Ave
Singapore
168751
Singapore

Study information

Study designRandomised controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleRandomized controlled trial evaluating an incentive-based community eye-care programme for elderly with visual impairment
Study objectivesTo evaluate the efficacy of an incentive-care scheme (ICS) to improve the attendance rates of tertiary eye-care visits following community eye screening using a randomized controlled trial design.
Ethics approval(s)Singhealth IRB, 17/04/2014, ref: R1102/4/2014
Health condition(s) or problem(s) studiedVisual impairment
InterventionEligible 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.
Intervention type
Primary outcome measureUptake of tertiary referral, measured using attendance to tertiary hospital at 3 months
Secondary outcome measures1. 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
Overall study start date01/01/2012
Completion date01/01/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants140
Key inclusion criteria1. 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
Key exclusion criteriaAbsence of the inclusion criteria and any other contraindication(s) as indicated by the general practitioner responsible for the participant
Date of first enrolment01/06/2014
Date of final enrolment01/06/2016

Locations

Countries of recruitment

  • Singapore

Study participating centre

Singapore National Eye Centre
168751

Sponsor information

Singapore National Eye Centre
Hospital/treatment centre

11 Third Hospital Ave
Singapore
168751
Singapore

ROR logo "ROR" https://ror.org/029nvrb94

Funders

Funder type

Hospital/treatment centre

Singapore National Eye Centre

No information available

Results and Publications

Intention to publish date01/01/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr Marcus Ang (marcus.ang@snec.com.sg). Data is available for 1 year and is masked with no identifiers. Informed consent was taken from all participants.