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

Primary Purpose

Vision, Low, Child, Adolescent Development

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tablet computer
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vision, Low

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meera and L B Deshpande Centre for Sight Enhancement, L V Prasad Eye InstituteRecruiting
  • South Essex Partnership Foundation Trust - Child Development Centre Bedford
  • Moorfields Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Assistive technology: tablet computer

Standard optical low vision devices

Arm Description

iPad tablet computers

standard optical devices including magnifiers, telescopes, CCTV

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 19, 2016
Last Updated
June 8, 2016
Sponsor
University College, London
Collaborators
L.V. Prasad Eye Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02798848
Brief Title
CREATE - Children Reading With Electronic Assistance To Educate
Acronym
CREATE
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
L.V. Prasad Eye Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vision, Low, Child, Adolescent Development

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Assistive technology: tablet computer
Arm Type
Experimental
Arm Description
iPad tablet computers
Arm Title
Standard optical low vision devices
Arm Type
Active Comparator
Arm Description
standard optical devices including magnifiers, telescopes, CCTV
Intervention Type
Device
Intervention Name(s)
Tablet computer
Intervention Description
iPad
Primary Outcome Measure Information:
Title
acceptance/usage, measured as ordinal variable by participant diary
Description
0 = no acceptance, 1 = acceptance as described, 2 = used frequently
Time Frame
six months
Title
accessibility measured as ordinal variable as score on a touch-based game, "Piano Tiles"
Description
0 = not accessible, 1 = accessible with help, 2 = accessible independently
Time Frame
six months
Title
recruitment rates into the trial
Description
recruitment rate and reasons for not taking part
Time Frame
six months
Secondary Outcome Measure Information:
Title
Cardiff Visual Ability Questionnaire for Children (CVAQC) score
Description
Functional visual ability scale, for participants in the UK
Time Frame
six months
Title
LV Prasad Functional Vision Questionnaire
Description
Vision related quality of life scale, for participants in India
Time Frame
six months
Title
Impact of Vision Impairment for Children (IVI_C) Questionnaire
Description
Functional vision, all participants
Time Frame
six months
Title
Neale Analysis of Reading Ability (NARA)
Description
reading accuracy, comprehension and speed
Time Frame
six months
Title
International Reading Speed Texts (IREST)
Description
reading speed
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Emerton
Phone
0044 203 447 7430
Email
Suzanne.Emerton@uclh.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annegret Dahlmann-Noor, PhD
Organizational Affiliation
Moorfields Eye Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meera and L B Deshpande Centre for Sight Enhancement, L V Prasad Eye Institute
City
Hyderabad
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijay Gothwal, PhD
Email
colonel@lvpei.org
First Name & Middle Initial & Last Name & Degree
Vitaya Gothwal, PhD
Facility Name
South Essex Partnership Foundation Trust - Child Development Centre Bedford
City
Bedford
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mays Jawad
Phone
0044 20 7253 3411
Email
mays.jawad@moorfields.nhs.uk
First Name & Middle Initial & Last Name & Degree
Annegret Dahlmann-Noor, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30153236
Citation
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.
Results Reference
derived
PubMed Identifier
28637740
Citation
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.
Results Reference
derived

Learn more about this trial

CREATE - Children Reading With Electronic Assistance To Educate

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