Viewing Study NCT03560765



Ignite Creation Date: 2024-05-06 @ 11:37 AM
Last Modification Date: 2024-10-26 @ 12:47 PM
Study NCT ID: NCT03560765
Status: TERMINATED
Last Update Posted: 2021-11-19
First Post: 2018-05-22

Brief Title: Mobile Electronic Devices for Visual Impairment
Sponsor: University of Manchester
Organization: University of Manchester

Study Overview

Official Title: Training in the Use of Smartphones and Tablets to Improve Quality of Life in Visual Impairment - Mobile Electronic Devices for Visual Impairment
Status: TERMINATED
Status Verified Date: 2021-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: No longer able to recruit due to COVID lockdowns
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MED4VI
Brief Summary: Mobile electronic devices MED including smartphones and tablets offer a new type of assistive technology for visually-impaired people VIP They offer the possibility to replace optical magnifiers for those with mild impairment and braille or auditory for those with severe visual loss using standard consumer devices which are relatively cheap and convenient However not all VIP and rehabilitation professionals are familiar with the devices and their potential

In this study VIP who are interested in purchasing a MED will be recruited and trained The effectiveness of this training will be determined by assessing the usage of devices by the participants from completion of training to 6 months using questionnaires and by remote monitoring of their MED Validated questionnaires will be used to measure changes in quality of life depression adaptation to vision loss and ability to carry out everyday tasks before and after training and 6 months later Ongoing support has been found to be important when introducing users to new technology in the form of volunteers to provide assistance and advice The standard training course only model will therefore be compared to a scheme in which each participant is paired with a buddy a university student who can provide continuing support by visiting the VIP regularly at home
Detailed Description: By converting text into speech and being cheaply and readily available smartphones and tablets offer a completely new type of assistive technology for visually-impaired people VIP Research on these mobile electronic devices MED is relevant to rehabilitation and enablement of individuals with all types of visual impairment with all degrees of severity The majority of UK adults have a smartphone but take-up is least amongst the over 75s who form the majority of the VI population This is the population in whom MED have the greatest potential to reduce social isolation and increase independence so it is important that the potential benefits are not restricted to those already comfortable with technology Despite the great interest regarding what could be achieved with MED evidence is currently lacking that they do provide significant improvements in quality of life and that the specific training which is currently offered by many different organisations can help to facilitate effective use of MED

The study aim is to evaluate the effectiveness of two different models of training in giving the user on-going access and improved quality of life The two models to be compared will be a training course only versus a scheme in which each participant is paired with a buddy a local university student who can provide continuing assistance by visiting the participant at home

VIP who are interested in purchasing a MED will be recruited and trained The usage of devices will be assessed by questionnaire from completion of training to 6 months and through a tracking app Validated questionnaires will be used to measure changes in quality of life depression adaptation to vision loss and ability to carry out everyday tasks before and after training and 6 months later

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None