CREATE - Children Reading With Electronic Assistance To Educate

NCT ID: NCT02798848

Last Updated: 2016-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vision, Low Child Adolescent Development

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Assistive technology: tablet computer

iPad tablet computers

Group Type EXPERIMENTAL

Tablet computer

Intervention Type DEVICE

iPad

Standard optical low vision devices

standard optical devices including magnifiers, telescopes, CCTV

Group Type ACTIVE_COMPARATOR

Tablet computer

Intervention Type DEVICE

iPad

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tablet computer

iPad

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

L.V. Prasad Eye Institute

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Annegret Dahlmann-Noor, PhD

Role: PRINCIPAL_INVESTIGATOR

Moorfields Eye Hospital NHS Foundation Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Hyderabad, , India

Site Status RECRUITING

South Essex Partnership Foundation Trust - Child Development Centre Bedford

Bedford, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Moorfields Eye Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

India United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Suzanne Emerton

Role: CONTACT

0044 203 447 7430

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Vijay Gothwal, PhD

Role: primary

Mays Jawad

Role: primary

0044 20 7253 3411

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30153236 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28637740 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15/0570

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.