CREATE - Children Reading With Electronic Assistance To Educate

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Tablet Computers Versus Optical Aids to Support Education and Learning in Children and Young People With Low Vision: a Pilot Randomized Controlled Trial

Conditions
-----------------
Vision, Low, Child, Adolescent Development

Intervention / Treatment
-----------------
* Device: Tablet computer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: current or previous use of a tablet computer for educational purposes

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assistive technology: tablet computer<br>iPad tablet computers | Device: Tablet computer<br>* iPad<br>|
| Active Comparator: Standard optical low vision devices<br>standard optical devices including magnifiers, telescopes, CCTV | Device: Tablet computer<br>* iPad<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acceptance/usage, measured as ordinal variable by participant diary | 0 = no acceptance, 1 = acceptance as described, 2 = used frequently | six months | 
| accessibility measured as ordinal variable as score on a touch-based game, Piano Tiles | 0 = not accessible, 1 = accessible with help, 2 = accessible independently | six months | 
| recruitment rates into the trial | recruitment rate and reasons for not taking part | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiff Visual Ability Questionnaire for Children (CVAQC) score | Functional visual ability scale, for participants in the UK | six months | 
| LV Prasad Functional Vision Questionnaire | Vision related quality of life scale, for participants in India | six months | 
| Impact of Vision Impairment for Children (IVI_C) Questionnaire | Functional vision, all participants | six months | 
| Neale Analysis of Reading Ability (NARA) | reading accuracy, comprehension and speed | six months | 
| International Reading Speed Texts (IREST) | reading speed | six months |