Clinical trial NCT03560765: Mobile Electronic Devices for Visual Impairment
Official title: Training in the Use of Smartphones and Tablets to Improve Quality of Life in Visual Impairment - Mobile Electronic Devices for Visual Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vision, Low
Keywords: Rehabilitation
Assistive technology
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: City, University of London
name: Schepens Eye Research Institute
First posted: 2018-06-18
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* EITHER expresses an interest/referred specifically for MED training
* OR After evaluation it appears that MED would meet some/all requirements
* Willing to delay involvement in other forms of training or befriending for 6 months
* Has some form vision - does not rely exclusively on other senses
* Willing to travel for training/evaluation/meeting with buddy
* Agree not to seek additional formal/organised MED training elsewhere during the study
* Willing to fund any required MED personally
* Habitual language English
* 6 item Cognitive Impairment Test score 7 or lower
* Best corrected visual acuity logMAR 0.5 - 1.6 and/or log contrast sensitivity \<1.2

Exclusion Criteria:

* Will be undergoing other one-to-one/group training (for anything) at the same time
* Will be undergoing other MED/general computer training at the same time
* Will be actively enrolled in a new befriending/social group
* Already knows basics of MED and wants training on advanced skills
* Obvious cognitive impairment or uncorrected hearing loss such that communication is through a third party
* If updated Rx would improve VA by 2 lines or more, participant should be recommended to seek eye exam and then be re-evaluated 1 month later
* Visual condition likely to be treated/improved within study period such that MED no longer required

Primary outcomes:
measure: Vision QoL Core Measure VCM-1
timeFrame: 2 months
measure: Vision QoL Core Measure VCM-1
timeFrame: 6 months
Secondary outcomes:
measure: Centre for Epidemiological Studies Depression Scale (CES-D)
timeFrame: 2 months
measure: Centre for Epidemiological Studies Depression Scale (CES-D)
timeFrame: 6 months
measure: Acceptance and Self Worth Adjustment Scale ASWAS
timeFrame: 2 months
measure: Acceptance and Self Worth Adjustment Scale ASWAS
timeFrame: 6 months
measure: Modified Manchester Low Vision Questionnaire with Canadian Occupational Performance Measure
timeFrame: 2 months
measure: Modified Manchester Low Vision Questionnaire with Canadian Occupational Performance Measure
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: City University of London
city: Manchester
country: United Kingdom
facility: University of Manchester
Study officials:
affiliation: University of Manchester
name: Chris Dickinson
role: PRINCIPAL_INVESTIGATOR
References: