CREATE - Children Reading With Electronic Assistance To Educate
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- acceptance/usage, measured as ordinal variable by participant diary [six months]
0 = no acceptance, 1 = acceptance as described, 2 = used frequently
- accessibility measured as ordinal variable as score on a touch-based game, "Piano Tiles" [six months]
0 = not accessible, 1 = accessible with help, 2 = accessible independently
- recruitment rates into the trial [six months]
recruitment rate and reasons for not taking part
Secondary Outcome Measures
- Cardiff Visual Ability Questionnaire for Children (CVAQC) score [six months]
Functional visual ability scale, for participants in the UK
- LV Prasad Functional Vision Questionnaire [six months]
Vision related quality of life scale, for participants in India
- Impact of Vision Impairment for Children (IVI_C) Questionnaire [six months]
Functional vision, all participants
- Neale Analysis of Reading Ability (NARA) [six months]
reading accuracy, comprehension and speed
- International Reading Speed Texts (IREST) [six months]
reading speed
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Meera and L B Deshpande Centre for Sight Enhancement, L V Prasad Eye Institute | Hyderabad | India | ||
| 2 | South Essex Partnership Foundation Trust - Child Development Centre Bedford | Bedford | United Kingdom | ||
| 3 | Moorfields Eye Hospital | London | United Kingdom | EC1V 2PD |
Sponsors and Collaborators
- University College, London
- L.V. Prasad Eye Institute
Investigators
- Principal Investigator: Annegret Dahlmann-Noor, PhD, Moorfields Eye Hospital NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15/0570