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CREATE - Children Reading With Electronic Assistance To Educate

NCT02798848 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-06-14

No results posted yet for this study

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

Interventions

DEVICE

Tablet computer

iPad

Sponsors & Collaborators

  • L.V. Prasad Eye Institute

    collaborator OTHER

  • University College, London

    lead OTHER

Principal Investigators

  • Annegret Dahlmann-Noor, PhD · Moorfields Eye Hospital NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-12-31
Completion
2017-02-28

Countries

  • India
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02798848 on ClinicalTrials.gov