Clinical trial NCT01879501: Living Successfully With Chronic Eye Diseases
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Singapore Eye Research Institute
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Singapore
name: University of Melbourne
name: Singapore National Eye Centre
name: Curtin University
First posted: 2013-06-17
Enrollment: 160
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Vision-related quality of life
timeFrame: up to 12 months post intervention
Secondary outcomes:
measure: Perceived self-efficacy, emotional well being, and vision-specific distress
timeFrame: baseline (before randomization to either usual care or intervention group); 2 weeks, 6 months and 12 months post intervention
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
Study officials:
affiliation: Singapore Eye Research Institute (SERI)
name: Peggy PC Chiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: