跳至主要内容
临床试验/NCT01879501
NCT01879501Unknown不适用

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

Singapore Eye Research Institute2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
2
主要终点
Vision-related quality of life

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Not matching the above

结局指标

主要结局

Vision-related quality of life

时间窗: up to 12 months post intervention

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peggy Pei-Chia Chiang

Doctor

Singapore Eye Research Institute

研究点 (2)

Loading locations...

相似试验