Chronic DiseasesADAPT-LAHNCT01879501
Living Successfully With Chronic Eye Diseases
A study testing Low Vision Self-Management Program in people with Chronic Diseases and Low Vision, run by Singapore Eye Research Institute at 1 site in Singapore.
Trial summary
The need for low vision services (LVS) will increase exponentially over the coming years due to the anticipated and exponential growth in the ageing population in Singapore and a rise in chronic non-communicable eye diseases. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Chronic Diseases, Low Vision, Diabetic Retinopathy
- What is being tested?
- Low Vision Self-Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2013to Jan 2015
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 years to 75 years
- Visual acuity ≤6/12 to ≤6/480 in the better eye after best correction OR
- Visual field of less than 10 degrees from the point of fixation, but with the potential to use vision for the planning and/or execution of a task
- Duration of low vision ≥ 2 years
- No cognitive impairment (as assessed with the 6-item cognitive impairment test)
- Have adequate hearing with/without aids to respond to normal conversation
Who cannot join
- Not matching the above
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore National Eye Centre
Singapore, Singapore, 168751
Priscilla Lim, +6597479490, Priscilla.Lim.S.H@snec.com.sg
Ching Siong Tey, BSc, +6592968690, tey.ching.siong@seri.com.sg
About this study
Official title: Living Successfully With Chronic Eye Diseases: the 'Living Successfully With Low Vision' (LSLV) Program - a Randomized Controlled Trial of a Self-management Program for Low Vision
The need for low vision services (LVS) will increase exponentially over the coming years due to the anticipated and exponential growth in the ageing population in Singapore and a rise in chronic non-communicable eye diseases. Finding the best evidenced-based management for chronic eye diseases contributing to low vision (LV) is therefore crucial. Improving patient responsibility is the key to managing LV effectively.1 This means achieving optimum self management (SM).2 However, there are currently no LV SM programs in Singapore and none has been evaluated using a randomized controlled trial (RCT) design, the gold standard methods to evaluate health interventions.
The aims of this study are to assess the effectiveness of the 'Living Successfully with Low Vision (LSLV)' program in improving quality of life (QoL) in 160 elderly people with LV attending the Singapore National Eye Centre (SNEC) LV clinic. Of these, 80 will be randomly allocated to receive the LSLV 4-week SM program while the remaining 80 will receive the usual care. Comparisons will be made to determine the efficacy of the LSLV program. QoL, self-efficacy, emotional well being, and vision-specific distress will be assessed 2 weeks after training, and at six months and 12 months post intervention.
This study will be the first evidenced-based RCT investigating the effectiveness of a novel vision-specific self-management strategy to improve QoL. It will also adopt a longitudinal design where the effectiveness of these interventions will be evaluated at 12 months-the first follow-up assessment of that duration at both national and international levels. Furthermore this will be the first study to characterize and profile the patients where the effect of the program did not demonstrate an improvement in both primary and secondary outcomes six months after its completion. The future clinical implications of this study include the potential to implement a successful model of LV rehabilitation in other tertiary centres around the country.
Read the detailed description
The need for low vision services (LVS) will increase exponentially over the coming years due to the anticipated and exponential growth in the ageing population in Singapore and a rise in chronic non-communicable eye diseases. Finding the best evidenced-based management for chronic eye diseases contributing to low vision (LV) is therefore crucial. Improving patient responsibility is the key to managing LV effectively.1 This means achieving optimum self management (SM).2 However, there are currently no LV SM programs in Singapore and none has been evaluated using a randomized controlled trial (RCT) design, the gold standard methods to evaluate health interventions.
- Conditions
- Chronic Diseases, Low Vision, Diabetic Retinopathy, Glaucoma, Age-related Macular Degeneration
- Being tested
- Low Vision Self-Management Program
- Keywords
- Low vision, Self management, Randomized controlled trial, Quality of life, Self efficacy, Effectiveness, Chronic eye diseases management
- Medical subject headings
- Chronic Disease, Vision, Low, Diabetic Retinopathy, Glaucoma, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Vision Self-Management ProgramBehavioural
The program has been describe above.
| Study group | Role | What they receive |
|---|---|---|
| Low Vision Self-Management Program | Experimental | Intervention: The program will work with participants to choose a specific and achievable goal they wish to achieve, involve participants in the learning process, provide information, explore experiences with low vision, and solutions to develop problem solving skills to enhance self efficacy. Participants will learn new techniques to cope with their activities of daily living. In addition to this, local guest experts in the field will be sourced and invited to provide training in aspects of low vision care. Receives: Behavioral: Low Vision Self-Management Program |
| Usual Care | No intervention | Usual care delivered at the Singapore National Eye Centre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision-related quality of life
Measured: up to 12 months post intervention
Secondary outcomes (1)
Perceived self-efficacy, emotional well being, and vision-specific distress
Measured: baseline (before randomization to either usual care or intervention group); 2 weeks, 6 months and 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseasesStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Eye Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore, University of Melbourne, Singapore National Eye Centre, Curtin University
- Responsible party
- Principal investigator, Peggy Pei-Chia Chiang, Singapore Eye Research Institute
- Investigators
- Peggy PC Chiang, PhD, Principal investigator, Singapore Eye Research Institute (SERI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879501
- Sponsor's protocol ID
- HSRG11MAY005
- Acronym
- ADAPT-LAH
- Status last verified
- Jun 2013
- First submitted
- 10 Apr 2013
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Successfully With Chronic Eye Diseases: the 'Living Successfully With Low Vision' (LSLV) Program - a Randomized Controlled Trial of a Self-management Program for Low Vision
- ClinicalTrials.gov ID
- NCT01879501
- Acronym / sponsor ID
- ADAPT-LAH / HSRG11MAY005
- Conditions
- Chronic Diseases, Low Vision, Diabetic Retinopathy, Glaucoma, Age-related Macular Degeneration
- Keywords
- Low vision, Self management, Randomized controlled trial, Quality of life, Self efficacy, Effectiveness, Chronic eye diseases management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Singapore Eye Research InstituteUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore, University of Melbourne, Singapore National Eye Centre, Curtin University
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 17 Jun 2013 (estimated)
- 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.
The need for low vision services (LVS) will increase exponentially over the coming years due to the anticipated and exponential growth in the ageing population in Singapore and a rise in chronic non-communicable eye diseases. Finding the best evidenced-based management for chronic eye diseases contributing to low vision (LV) is therefore crucial. Improving patient responsibility is the key to managing LV effectively.1 This means achieving optimum self management (SM).2 However, there are currently no LV SM programs in Singapore and none has been evaluated using a randomized controlled trial (RCT) design, the gold standard methods to evaluate health interventions.
The aims of this study are to assess the effectiveness of the 'Living Successfully with Low Vision (LSLV)' program in improving quality of life (QoL) in 160 elderly people with LV attending the Singapore National Eye Centre (SNEC) LV clinic. Of these, 80 will be randomly allocated to receive the LSLV 4-week SM program while the remaining 80 will receive the usual care. Comparisons will be made to determine the efficacy of the LSLV program. QoL, self-efficacy, emotional well being, and vision-specific distress will be assessed 2 weeks after training, and at six months and 12 months post intervention.
This study will be the first evidenced-based RCT investigating the effectiveness of a novel vision-specific self-management strategy to improve QoL. It will also adopt a longitudinal design where the effectiveness of these interventions will be evaluated at 12 months-the first follow-up assessment of that duration at both national and international levels. Furthermore this will be the first study to characterize and profile the patients where the effect of the program did not demonstrate an improvement in both primary and secondary outcomes six months after its completion. The future clinical implications of this study include the potential to implement a successful model of LV rehabilitation in other tertiary centres around the country.
Detailed description
The need for low vision services (LVS) will increase exponentially over the coming years due to the anticipated and exponential growth in the ageing population in Singapore and a rise in chronic non-communicable eye diseases. Finding the best evidenced-based management for chronic eye diseases contributing to low vision (LV) is therefore crucial. Improving patient responsibility is the key to managing LV effectively.1 This means achieving optimum self management (SM).2 However, there are currently no LV SM programs in Singapore and none has been evaluated using a randomized controlled trial (RCT) design, the gold standard methods to evaluate health interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Vision Self-Management Program | Experimental | Behavioral: Low Vision Self-Management ProgramIntervention: The program will work with participants to choose a specific and achievable goal they wish to achieve, involve participants in the learning process, provide information, explore experiences with low vision, and solutions to develop problem solving skills to enhance self efficacy. Participants will learn new techniques to cope with their activities of daily living. In addition to this, local guest experts in the field will be sourced and invited to provide training in aspects of low vision care. |
| Usual Care | No intervention | –Usual care delivered at the Singapore National Eye Centre |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 45 years to 75 years
- Visual acuity ≤6/12 to ≤6/480 in the better eye after best correction OR
- Visual field of less than 10 degrees from the point of fixation, but with the potential to use vision for the planning and/or execution of a task
- Duration of low vision ≥ 2 years
- No cognitive impairment (as assessed with the 6-item cognitive impairment test)
Key exclusion criteria (1 listed)
- Not matching the above
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 |
|---|---|---|
| Low Vision Self-Management ProgramThe program has been describe above. | Behavioural | Low Vision Self-Management Program |
Primary outcome
Vision-related quality of life
Time frame: up to 12 months post intervention
1 secondary outcome
Perceived self-efficacy, emotional well being, and vision-specific distress
Time frame: baseline (before randomization to either usual care or intervention group); 2 weeks, 6 months and 12 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
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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.
Peggy PC Chiang, PhD principal investigator
Singapore Eye Research Institute (SERI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Vision Self-Management Program in people with Chronic Diseases and Low Vision, run by Singapore Eye Research Institute at 1 site in Singapore.
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 6 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: status not confirmed, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peggy Chiang, PhD (+6598548096, peggy.chiang.p.c@seri.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vision-related quality of life (time frame: up to 12 months post intervention). 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 17 Jun 2013.