Mobile Electronic Devices for Visual Impairment

NCT03560765 | Terminated

• 1 other identifier: 5049/5050
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Vision, Low

Keywords

Rehabilitation; Assistive technology

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (6)

• Centre for Epidemiological Studies Depression Scale (CES-D)

  2 months

• Centre for Epidemiological Studies Depression Scale (CES-D)

  6 months

• Acceptance and Self Worth Adjustment Scale ASWAS

  2 months

• Acceptance and Self Worth Adjustment Scale ASWAS

  6 months

• Modified Manchester Low Vision Questionnaire with Canadian Occupational Performance Measure

  2 months

Study Arms (4)

Using MED assigned buddy

EXPERIMENTAL

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

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

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

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

Interventions

MED DEVICE

Training in the use of mainstream electronic devices with accessibility options

Also known as: smartphone, tablet, mobile electronic device

Using MED assigned buddy; Using MED training only

Buddy OTHER

A buddy who will meet with the participant regularly for social interaction, and assistance with use of any MED purchased

Also known as: Student volunteer

No MED, assigned buddy; Using MED assigned buddy

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• item Cognitive Impairment Test score 7 or lower
• Best corrected visual acuity logMAR 0.5 - 1.6 and/or log contrast sensitivity \<1.2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead
• City, University of London: collaborator
• Schepens Eye Research Institute: collaborator

Study Sites (2)

City University of London

London, EC1V 0HB, United Kingdom

Location

University of Manchester

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Vision, Low

Interventions

Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Chris Dickinson

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Optometry

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 18, 2018
• Study Start: August 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: November 19, 2021

Record last verified: 2021-11

Locations

GB (2)