CREATE - Children Reading With Electronic Assistance To Educate (CREATE)

June 8, 2016 updated by: University College, London

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Hyderabad, India
        • Recruiting
        • Meera and L B Deshpande Centre for Sight Enhancement, L V Prasad Eye Institute
        • Contact:
        • Principal Investigator:
          • Vitaya Gothwal, PhD
  • United Kingdom
      • Bedford, United Kingdom
        • Active, not recruiting
        • South Essex Partnership Foundation Trust - Child Development Centre Bedford
      • London, United Kingdom, EC1V 2PD
        • Recruiting
        • Moorfields Eye Hospital
        • Contact:
        • Principal Investigator:
          • Annegret Dahlmann-Noor, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Assistive technology: tablet computer
iPad tablet computers
Device: Tablet computer
iPad
ACTIVE_COMPARATOR: Standard optical low vision devices
standard optical devices including magnifiers, telescopes, CCTV
Device: Tablet computer
iPad

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acceptance/usage, measured as ordinal variable by participant diary
Time Frame: six months
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"
Time Frame: six months

0 = not accessible,

1 = accessible with help, 2 = accessible independently
six months
recruitment rates into the trial
Time Frame: six months
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
Time Frame: six months
Functional visual ability scale, for participants in the UK
six months
LV Prasad Functional Vision Questionnaire
Time Frame: six months
Vision related quality of life scale, for participants in India
six months
Impact of Vision Impairment for Children (IVI_C) Questionnaire
Time Frame: six months
Functional vision, all participants
six months
Neale Analysis of Reading Ability (NARA)
Time Frame: six months
reading accuracy, comprehension and speed
six months
International Reading Speed Texts (IREST)
Time Frame: six months
reading speed
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

L.V. Prasad Eye Institute

Investigators

  • Principal Investigator: Annegret Dahlmann-Noor, PhD, Moorfields Eye Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

February 1, 2017

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (ESTIMATE)

June 14, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/0570

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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