CREATE - Children Reading With Electronic Assistance To Educate

University College, London40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Vision, Low Child Adolescent Development

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Meera and L B Deshpande Centre for Sight Enhancement, L V Prasad Eye Institute

Hyderabad, India

RECRUITING

South Essex Partnership Foundation Trust - Child Development Centre Bedford

Bedford, United Kingdom

ACTIVE_NOT_RECRUITING

Moorfields Eye Hospital

London, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

acceptance/usage, measured as ordinal variable by participant diary

0 = no acceptance, 1 = acceptance as described, 2 = used frequently

Time frame: 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

Time frame: six months

recruitment rates into the trial

recruitment rate and reasons for not taking part

Time frame: six months

Secondary Outcomes

Cardiff Visual Ability Questionnaire for Children (CVAQC) score

Functional visual ability scale, for participants in the UK

Time frame: six months

LV Prasad Functional Vision Questionnaire

Vision related quality of life scale, for participants in India

Time frame: six months

Impact of Vision Impairment for Children (IVI_C) Questionnaire

Functional vision, all participants

Time frame: six months

Neale Analysis of Reading Ability (NARA)

reading accuracy, comprehension and speed

Time frame: six months

International Reading Speed Texts (IREST)

reading speed

Time frame: six months

CREATE - Children Reading With Electronic Assistance To Educate

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts