Living Successfully With Chronic Eye Diseases (ADAPT-LAH)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Diseases Low Vision Diabetic Retinopathy Glaucoma Age-related Macular Degeneration |
Behavioral: Low Vision Self-Management Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| 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 |
- Vision-related quality of life [ Time Frame: up to 12 months post intervention ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Low Vision Self-Management Program
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.
|
Behavioral: Low Vision Self-Management Program
The program has been describe above.
|
|
No Intervention: Usual Care
Usual care delivered at the Singapore National Eye Centre
|
Detailed Description:
Eligibility| Ages Eligible for Study: | 45 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not matching the above
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01879501
| Contact: Peggy Chiang, PhD | +6598548096 | peggy.chiang.p.c@seri.com.sg | |
| Contact: Chye Fong Peck | +6593382666 | peck.chye.fong@seri.com.sg |
| Singapore | |
| Singapore National Eye Centre | Recruiting |
| Singapore, Singapore, 168751 | |
| Contact: Priscilla Lim +6597479490 Priscilla.Lim.S.H@snec.com.sg | |
| Contact: Ching Siong Tey, BSc +6592968690 tey.ching.siong@seri.com.sg | |
| Principal Investigator: Peggy Chiang, PhD | |
| Sub-Investigator: Ecosse Lamoureux, PhD | |
| Sub-Investigator: Vicki Drury, PhD | |
| Sub-Investigator: Tien Yin Wong, PhD | |
| Principal Investigator: | Peggy PC Chiang, PhD | Singapore Eye Research Institute (SERI) |
More Information
| Responsible Party: | Peggy Pei-Chia Chiang, Doctor, Singapore Eye Research Institute |
| ClinicalTrials.gov Identifier: | NCT01879501 History of Changes |
| Other Study ID Numbers: | HSRG11MAY005 |
| Study First Received: | April 10, 2013 |
| Last Updated: | June 14, 2013 |
| Health Authority: | Singapore: Ministry of Health |
Keywords provided by Singapore Eye Research Institute:
|
Low vision Self management Randomized controlled trial Quality of life |
Self efficacy Effectiveness Chronic eye diseases management |
Additional relevant MeSH terms:
|
Glaucoma Macular Degeneration Diabetic Retinopathy Chronic Disease Eye Diseases Vision, Low Ocular Hypertension Retinal Degeneration Retinal Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Disease Attributes Pathologic Processes Vision Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on September 30, 2016