CREATE - Children Reading With Electronic Assistance To Educate

Not Applicable

• Conditions: Child; Vision, Low; Adolescent Development
• Interventions: Device: Tablet computer

• Registration Number: NCT02798848
• Lead Sponsor: University College, London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-04
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-06-08
• Last Update Submitted: 2016-06-08
• Study First Posted: 2016-06-14
• Last Update Posted: 2016-06-14
• Primary Completion: 2016-12
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard optical low vision devices	Tablet computer	standard optical devices including magnifiers, telescopes, CCTV
Assistive technology: tablet computer	Tablet computer	iPad tablet computers

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Meera and L B Deshpande Centre for Sight Enhancement, L V Prasad Eye Institute; 🇮🇳 Hyderabad, India

South Essex Partnership Foundation Trust - Child Development Centre Bedford; 🇬🇧 Bedford, United Kingdom

Moorfields Eye Hospital; 🇬🇧 London, United Kingdom