CREATE - Children Reading With Electronic Assistance To Educate

NCT02798848 | Unknown

• 1 other identifier: 15/0570
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 3

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.

Conditions

Vision, Low; Child; Adolescent Development

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Cardiff Visual Ability Questionnaire for Children (CVAQC) score

  six months

• LV Prasad Functional Vision Questionnaire

  six months

• Impact of Vision Impairment for Children (IVI_C) Questionnaire

  six months

• Neale Analysis of Reading Ability (NARA)

  six months

• International Reading Speed Texts (IREST)

  six months

Study Arms (2)

Assistive technology: tablet computer

EXPERIMENTAL

iPad tablet computers

Device: Tablet computer

Standard optical low vision devices

ACTIVE COMPARATOR

standard optical devices including magnifiers, telescopes, CCTV

Device: Tablet computer

Interventions

Tablet computer DEVICE

iPad

Assistive technology: tablet computer; Standard optical low vision devices

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• current or previous use of a tablet computer for educational purposes

Sponsors & Collaborators

• University College, London: lead
• L.V. Prasad Eye Institute: collaborator

Study Sites (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, EC1V 2PD, United Kingdom

RECRUITING

Related Publications (2)

• Gothwal VK, Thomas R, Crossland M, Bharani S, Sharma S, Unwin H, Xing W, Khabra K, Dahlmann-Noor A. Randomized Trial of Tablet Computers for Education and Learning in Children and Young People with Low Vision. Optom Vis Sci. 2018 Sep;95(9):873-882. doi: 10.1097/OPX.0000000000001270.

  PMID: 30153236 DERIVED

• Crossland MD, Thomas R, Unwin H, Bharani S, Gothwal VK, Quartilho A, Bunce C, Dahlmann-Noor A. Tablet computers versus optical aids to support education and learning in children and young people with low vision: protocol for a pilot randomised controlled trial, CREATE (Children Reading with Electronic Assistance To Educate). BMJ Open. 2017 Jun 21;7(6):e015939. doi: 10.1136/bmjopen-2017-015939.

  PMID: 28637740 DERIVED

MeSH Terms

Conditions

Vision, Low

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Annegret Dahlmann-Noor, PhD

  Moorfields Eye Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne Emerton

CONTACT

0044 203 447 7430; Suzanne.Emerton@uclh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: June 14, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: June 14, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); IN (1)