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Mobile Electronic Devices for Visual Impairment (MED4VI)

Primary Purpose

Vision, Low

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MED
Buddy
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vision, Low focused on measuring Rehabilitation, Assistive technology

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City University of London
  • University of Manchester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

Using MED assigned buddy

Using MED training only

No MED, assigned buddy

No MED, no buddy

Arm Description

Participant has been randomly assigned a student volunteer buddy, and has chosen to purchase an MED following training

Participant has been randomly assigned to not have a student volunteer buddy, and has chosen to purchase an MED following training

Participant has been randomly assigned a student volunteer buddy, and has chosen not to purchase an MED following training

Participant has been randomly assigned to not have a student volunteer buddy, and has chosen not to purchase an MED following training

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 22, 2018
Last Updated
November 11, 2021
Sponsor
University of Manchester
Collaborators
City, University of London, Schepens Eye Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03560765
Brief Title
Mobile Electronic Devices for Visual Impairment
Acronym
MED4VI
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
No longer able to recruit due to COVID lockdowns
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
Collaborators
City, University of London, Schepens Eye Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vision, Low
Keywords
Rehabilitation, Assistive technology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Using MED assigned buddy
Arm Type
Experimental
Arm Description
Participant has been randomly assigned a student volunteer buddy, and has chosen to purchase an MED following training
Arm Title
Using MED training only
Arm Type
Active Comparator
Arm Description
Participant has been randomly assigned to not have a student volunteer buddy, and has chosen to purchase an MED following training
Arm Title
No MED, assigned buddy
Arm Type
Active Comparator
Arm Description
Participant has been randomly assigned a student volunteer buddy, and has chosen not to purchase an MED following training
Arm Title
No MED, no buddy
Arm Type
No Intervention
Arm Description
Participant has been randomly assigned to not have a student volunteer buddy, and has chosen not to purchase an MED following training
Intervention Type
Device
Intervention Name(s)
MED
Other Intervention Name(s)
smartphone, tablet, mobile electronic device
Intervention Description
Training in the use of mainstream electronic devices with accessibility options
Intervention Type
Other
Intervention Name(s)
Buddy
Other Intervention Name(s)
Student volunteer
Intervention Description
A buddy who will meet with the participant regularly for social interaction, and assistance with use of any MED purchased
Primary Outcome Measure Information:
Title
Vision QoL Core Measure VCM-1
Description
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.
Time Frame
2 months
Title
Vision QoL Core Measure VCM-1
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Centre for Epidemiological Studies Depression Scale (CES-D)
Description
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.
Time Frame
2 months
Title
Centre for Epidemiological Studies Depression Scale (CES-D)
Description
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.
Time Frame
6 months
Title
Acceptance and Self Worth Adjustment Scale ASWAS
Description
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.
Time Frame
2 months
Title
Acceptance and Self Worth Adjustment Scale ASWAS
Description
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.
Time Frame
6 months
Title
Modified Manchester Low Vision Questionnaire with Canadian Occupational Performance Measure
Description
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.
Time Frame
2 months
Title
Modified Manchester Low Vision Questionnaire with Canadian Occupational Performance Measure
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Dickinson
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
City University of London
City
London
ZIP/Postal Code
EC1V 0HB
Country
United Kingdom
Facility Name
University of Manchester
City
Manchester
ZIP/Postal Code
M13 9PL
Country
United Kingdom

12. IPD Sharing Statement

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Mobile Electronic Devices for Visual Impairment

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