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Vision, LowCREATENCT02798848

CREATE - Children Reading With Electronic Assistance To Educate

A study testing Tablet computer in people with Vision, Low and Child, run by University College, London at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 18 years
Conditions the study is for
Vision, Low, Child, Adolescent Development
What is being tested?
Tablet computer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesin 2 countries
Study dates
Mar 2016to Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 2 countries.

Suzanne Emerton contact

0044 203 447 7430

Suzanne.Emerton@uclh.nhs.uk

3 sites in 2 countries

United Kingdom2 sites, 1 recruiting

  • South Essex Partnership Foundation Trust - Child Development Centre Bedford

    Bedford

    Active, not recruiting

  • Moorfields Eye Hospital

    London, EC1V 2PD

    Mays Jawad, 0044 20 7253 3411, mays.jawad@moorfields.nhs.uk

    Annegret Dahlmann-Noor, PhD

    Recruiting

Other trials in United Kingdom

India1 site, 1 recruiting

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

    Hyderabad

    Vijay Gothwal, PhD, colonel@lvpei.org

    Vitaya Gothwal, PhD

    Recruiting

Other trials in India

About this study

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

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.

Being tested
Tablet computer
Medical subject headings
Vision, Low

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tablet computerDevice

    iPad

Study groups in NCT02798848
Study groupRoleWhat they receive
Assistive technology: tablet computerExperimentaliPad tablet computers
Receives: Device: Tablet computer
Standard optical low vision devicesActive comparatorstandard optical devices including magnifiers, telescopes, CCTV
Receives: Device: Tablet computer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. acceptance/usage, measured as ordinal variable by participant diary

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

    Measured: six months

  2. accessibility measured as ordinal variable as score on a touch-based game, "Piano Tiles"

    0 = not accessible,

    1 = accessible with help, 2 = accessible independently

    Measured: six months

  3. recruitment rates into the trial

    recruitment rate and reasons for not taking part

    Measured: six months

Secondary outcomes (5)

  1. Cardiff Visual Ability Questionnaire for Children (CVAQC) score

    Functional visual ability scale, for participants in the UK

    Measured: six months

  2. LV Prasad Functional Vision Questionnaire

    Vision related quality of life scale, for participants in India

    Measured: six months

  3. Impact of Vision Impairment for Children (IVI_C) Questionnaire

    Functional vision, all participants

    Measured: six months

  4. Neale Analysis of Reading Ability (NARA)

    reading accuracy, comprehension and speed

    Measured: six months

  5. International Reading Speed Texts (IREST)

    reading speed

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionDec 2016 (estimated)
  4. Study completionFeb 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02798848
Sponsor's protocol ID
15/0570
Acronym
CREATE
Status last verified
Apr 2016
First submitted
19 Apr 2016
Last updated
14 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30153236

  • 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.

    PubMed 28637740

Questions about this trial

What is this clinical trial studying?

A study testing Tablet computer in people with Vision, Low and Child, run by University College, London at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom, India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Suzanne Emerton (0044 203 447 7430, Suzanne.Emerton@uclh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

acceptance/usage, measured as ordinal variable by participant diary (time frame: six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02798848, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.

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