Visual ImpairmentNCT03264885
Randomized Controlled Trial Evaluating an Incentive-based Community Eye-care Programme
A study testing Incentive Care in people with Visual Impairment, run by Singapore National Eye Centre.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment
- What is being tested?
- Incentive Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- refused informed consent and any other contraindication(s) as indicated by the general practitioner responsible for the participant
About this study
Official title: 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.
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.
- Conditions
- Visual Impairment
- Being tested
- Incentive Care
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive CareOther
ICS is a novel intervention that incorporates patient education, social support, and financial assistance to assist individuals.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | 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 |
| Incentive Care | Other | 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. Receives: Other: Incentive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to Tertiary Care Follow-up
Percentage of participants who attended follow-up
Measured: 3 months
Secondary outcomes (1)
Visual Acuity
Vision checked on Snellen chart
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Jan 2014
- Primary completion1 Jan 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marcus Ang, Principal investigator, SNEC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264885
- Sponsor's protocol ID
- R1102/4/2014
- Status last verified
- Aug 2017
- First submitted
- 24 Aug 2017
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating an Incentive-based Community Eye-care Programme for Elderly With Visual Impairment
- ClinicalTrials.gov ID
- NCT03264885
- Acronym / sponsor ID
- R1102/4/2014
- Conditions
- Visual Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –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 |
| Incentive Care | Other | Other: Incentive CareIn 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- refused informed consent and any other contraindication(s) as indicated by the general practitioner responsible for the participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentive CareICS is a novel intervention that incorporates patient education, social support, and financial assistance to assist individuals. | Other | Incentive Care |
Primary outcome
Compliance to Tertiary Care Follow-up
Time frame: 3 months
Percentage of participants who attended follow-up
1 secondary outcome
Visual Acuity
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: No. Data will not be available to other researchers
Related trials for Visual Impairment
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Iopidine to Decrease Intraocular Pressure Rise After Injections
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A Study About the Safety of a Single ASP2020 Eye Injection and if it Helps People With Vision Loss From Stargardt-type Eye Conditions
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Leveraging Artificial Intelligence to Prevent Vision Loss From Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Ang principal investigator
SNEC
Questions about this trial
What is this clinical trial studying?
A study testing Incentive Care in people with Visual Impairment, run by Singapore National Eye Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to Tertiary Care Follow-up (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.