Living Successfully With Chronic Eye Diseases

Not Applicable

• Conditions: Chronic Diseases; Low Vision; Diabetic Retinopathy; Glaucoma; Age-related Macular Degeneration
• Interventions: Behavioral: Low Vision Self-Management Program

• Registration Number: NCT01879501
• Lead Sponsor: Singapore Eye Research Institute

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-04-10
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-14
• Last Update Submitted: 2013-06-14
• Study First Posted: 2013-06-17
• Last Update Posted: 2013-06-17
• Primary Completion: 2014-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Vision Self-Management Program	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.

Primary Outcome Measures

Name	Time	Method
Vision-related quality of life	up to 12 months post intervention

Secondary Outcome Measures

Name	Time	Method
Perceived self-efficacy, emotional well being, and vision-specific distress	baseline (before randomization to either usual care or intervention group); 2 weeks, 6 months and 12 months post intervention

Trial Locations

Locations (1)

Singapore National Eye Centre; 🇸🇬 Singapore, Singapore