Tablet Computers Versus Optical Aids to Support Education and Learning in Children and Young People With Low Vision: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- recruitment rates into the trial
研究概览
简要总结
This pilot randomized controlled trial (RCT) will test the methodology for a full RCT of assistive technologies for children/young people with low vision/blindness. The investigators will recruit 40 students age 10-18 years in India and the UK, who will be randomised into two groups. Apple iPads will be the active intervention; the control arm will be the local standard low-vision aid care. Primary outcomes will be acceptance/usage and accessibility of the device and trial feasibility measures. Exploratory outcomes will be validated measures of vision-related quality of life for children/young people as well as validated measures of reading and educational outcomes. In addition, the investigators will carry out semistructured interviews with the participants and their teachers, and attempt to evaluate cost-effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •age 10-18 years
- •low vision, defined as "best corrected visual acuity (BCVA) for distance between - less than 6/18 (0.48 logMAR) and 3/60 (1.30 logMAR) in the better eye" (WHO) ability to read printed material
- •no previous or current use of a tablet computer for educational purposes We will include students who have access to a tablet computer already, but only use it for recreational purposes. We will also include students who use a laptop. We will also include students who use or have previously used optical low-vision aids such as magnifiers, telescopes and CCTV systems.
排除标准
- •current or previous use of a tablet computer for educational purposes
研究组 & 干预措施
Assistive technology: tablet computer
iPad tablet computers
干预措施: Tablet computer (Device)
Standard optical low vision devices
standard optical devices including magnifiers, telescopes, CCTV
干预措施: Tablet computer (Device)
结局指标
主要结局
recruitment rates into the trial
时间窗: six months
recruitment rate and reasons for not taking part
accessibility measured as ordinal variable as score on a touch-based game, "Piano Tiles"
时间窗: six months
0 = not accessible, 1 = accessible with help, 2 = accessible independently
acceptance/usage, measured as ordinal variable by participant diary
时间窗: six months
0 = no acceptance, 1 = acceptance as described, 2 = used frequently
次要结局
- LV Prasad Functional Vision Questionnaire(six months)
- International Reading Speed Texts (IREST)(six months)
- Impact of Vision Impairment for Children (IVI_C) Questionnaire(six months)
- Neale Analysis of Reading Ability (NARA)(six months)
- Cardiff Visual Ability Questionnaire for Children (CVAQC) score(six months)