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
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
Public
11 Third Hospital Ave
Singapore
168751
Singapore
Study information
| Study design | Randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Randomized controlled trial evaluating an incentive-based community eye-care programme for elderly with visual impairment |
| Study objectives | To 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) studied | Visual impairment |
| Intervention | 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. |
| Intervention type | |
| Primary outcome measure | Uptake of tertiary referral, measured using attendance to tertiary hospital at 3 months |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2012 |
| Completion date | 01/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 140 |
| Key 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 |
| Key exclusion criteria | Absence of the inclusion criteria and any other contraindication(s) as indicated by the general practitioner responsible for the participant |
| Date of first enrolment | 01/06/2014 |
| Date of final enrolment | 01/06/2016 |
Locations
Countries of recruitment
- Singapore
Study participating centre
Sponsor information
Hospital/treatment centre
11 Third Hospital Ave
Singapore
168751
Singapore
"ROR" |
https://ror.org/029nvrb94 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The 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. |
