Vision, LowMED4VINCT03560765
Mobile Electronic Devices for Visual Impairment
A study testing MED and Buddy in people with Vision, Low, run by University of Manchester at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Vision, Low
- What is being tested?
- MED and Buddy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Aug 2018to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
City University of London
London, EC1V 0HB
University of Manchester
Manchester, M13 9PL
About this study
Official title: Training in the Use of Smartphones and Tablets to Improve Quality of Life in Visual Impairment - Mobile Electronic Devices for Visual Impairment
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.
Read the 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.
- Conditions
- Vision, Low
- Being tested
- MED, Buddy
- Keywords
- Rehabilitation, Assistive technology
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDDevice
Also called smartphone, tablet, mobile electronic device
Training in the use of mainstream electronic devices with accessibility options
BuddyOther
Also called Student volunteer
A buddy who will meet with the participant regularly for social interaction, and assistance with use of any MED purchased
| Study group | Role | What they receive |
|---|---|---|
| Using MED assigned buddy | Experimental | Participant has been randomly assigned a student volunteer buddy, and has chosen to purchase an MED following training Receives: Device: MED; Other: Buddy |
| Using MED training only | Active comparator | Participant has been randomly assigned to not have a student volunteer buddy, and has chosen to purchase an MED following training Receives: Device: MED |
| No MED, assigned buddy | Active comparator | Participant has been randomly assigned a student volunteer buddy, and has chosen not to purchase an MED following training Receives: Other: Buddy |
| No MED, no buddy | No intervention | Participant has been randomly assigned to not have a student volunteer buddy, and has chosen not to purchase an MED following training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision QoL Core Measure VCM-1
A 9-item instrument to measure vision related quality of life. Each item scored from 0-4 with a maximum score of 36. Low score represents poor QoL.
Measured: 2 months
Vision QoL Core Measure VCM-1
A 9-item instrument to measure vision related quality of life. Each item scored from 0-4 with a maximum score of 36. Low score represents poor QoL.
Measured: 6 months
Secondary outcomes (6)
Centre for Epidemiological Studies Depression Scale (CES-D)
A 20-item instrument to measure self-reported depression. Each item scored from 0-3 with a maximum score of 60. Low score represents an absence of depression.
Measured: 2 months
Centre for Epidemiological Studies Depression Scale (CES-D)
A 20-item instrument to measure self-reported depression. Each item scored from 0-3 with a maximum score of 60. Low score represents an absence of depression.
Measured: 6 months
Acceptance and Self Worth Adjustment Scale ASWAS
A 19-item instrument which measures adaptation to acquired visual loss. Questions relate to self-esteem, attitudes, acceptance, self-efficacy, and locus of control. Each item scored from 0-4, and maximum score of 76 represents good acceptance and self-worth.
Measured: 2 months
Acceptance and Self Worth Adjustment Scale ASWAS
A 19-item instrument which measures adaptation to acquired visual loss. Questions relate to self-esteem, attitudes, acceptance, self-efficacy, and locus of control. Each item scored from 0-4, and maximum score of 76 represents good acceptance and self-worth.
Measured: 6 months
Modified Manchester Low Vision Questionnaire with Canadian Occupational Performance Measure
A questionnaire in 3 sections, each of which are independent.. Section 1 describes how the participant carries out a list of everyday activities (with which assistive device, and with how much assistance). Section 2 grades the amount of time that different aids are used (graded fro 0-4 with 4 representing the most usage). In Section 3 the participant identifies 5 activities which they would like to improve, and grades on a scale of 0-10) the importance of the task, their performance, and their satisfaction with their performance of it. An "importance x satisfaction" and "importance x performance" score for each activity are calculated.
Measured: 2 months
Modified Manchester Low Vision Questionnaire with Canadian Occupational Performance Measure
A questionnaire in 3 sections, each of which are independent. Section 1 describes how the participant carries out a list of everyday activities (with which assistive device, and with how much assistance). Section 2 grades the amount of time that different aids are used (graded fro 0-4 with 4 representing the most usage). In Section 3 the participant identifies 5 activities which they would like to improve, and grades on a scale of 0-10) the importance of the task, their performance, and their satisfaction with their performance of it. An "importance x satisfaction" and "importance x performance" score for each activity are calculated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 Aug 2018
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Why it stopped: No longer able to recruit due to COVID lockdowns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision, LowStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- City, University of London, Schepens Eye Research Institute
- Responsible party
- Principal investigator, Chris Dickinson, University of Manchester
- Investigators
- Chris Dickinson, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560765
- Sponsor's protocol ID
- 5049/5050
- Acronym
- MED4VI
- Status last verified
- Nov 2021
- First submitted
- 22 May 2018
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training in the Use of Smartphones and Tablets to Improve Quality of Life in Visual Impairment - Mobile Electronic Devices for Visual Impairment
- ClinicalTrials.gov ID
- NCT03560765
- Acronym / sponsor ID
- MED4VI / 5049/5050
- Conditions
- Vision, Low
- Keywords
- Rehabilitation, Assistive technology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No longer able to recruit due to COVID lockdowns
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- City, University of London, Schepens Eye Research Institute
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Using MED assigned buddy | Experimental | Device: MED, Other: BuddyParticipant has been randomly assigned a student volunteer buddy, and has chosen to purchase an MED following training |
| Using MED training only | Active comparator | Device: MEDParticipant has been randomly assigned to not have a student volunteer buddy, and has chosen to purchase an MED following training |
| No MED, assigned buddy | Active comparator | Other: BuddyParticipant has been randomly assigned a student volunteer buddy, and has chosen not to purchase an MED following training |
| No MED, no buddy | No intervention | –Participant has been randomly assigned to not have a student volunteer buddy, and has chosen not to purchase an MED following training |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDAlso: smartphone, tablet, mobile electronic deviceTraining in the use of mainstream electronic devices with accessibility options | Device | Using MED assigned buddy, Using MED training only |
| BuddyAlso: Student volunteerA buddy who will meet with the participant regularly for social interaction, and assistance with use of any MED purchased | Other | No MED, assigned buddy, Using MED assigned buddy |
Primary outcome
Vision QoL Core Measure VCM-1
Time frame: 2 months
A 9-item instrument to measure vision related quality of life. Each item scored from 0-4 with a maximum score of 36. Low score represents poor QoL.
Vision QoL Core Measure VCM-1
Time frame: 6 months
A 9-item instrument to measure vision related quality of life. Each item scored from 0-4 with a maximum score of 36. Low score represents poor QoL.
6 secondary outcomes
Centre for Epidemiological Studies Depression Scale (CES-D)
Time frame: 2 months
Centre for Epidemiological Studies Depression Scale (CES-D)
Time frame: 6 months
Acceptance and Self Worth Adjustment Scale ASWAS
Time frame: 2 months
Acceptance and Self Worth Adjustment Scale ASWAS
Time frame: 6 months
Modified Manchester Low Vision Questionnaire with Canadian Occupational Performance Measure
Time frame: 2 months
Modified Manchester Low Vision Questionnaire with Canadian Occupational Performance Measure
Time frame: 6 months
Results and safety
The study was stopped early (reason given: No longer able to recruit due to COVID lockdowns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Dickinson principal investigator
University of Manchester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MED and Buddy in people with Vision, Low, run by University of Manchester at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No longer able to recruit due to COVID lockdowns). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vision QoL Core Measure VCM-1 (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.