Plain English Summary
Background and study aims
There are many causes of low vision including age-related macular degeneration, diabetic retinopathy and glaucoma. People with low vision can suffer from depression, reduced quality of life and reduced mobility. When people lose some or all of their sight, they may be offered the services of a Rehabilitation Officer for the Vision Impaired. This person can look at things that are more difficult for someone with low vision – such as using magnifiers, or using lights to enhance remaining vision or finding aids that make everyday tasks safer. The Rehabilitation Officer works with you in your own home or office to help you come to terms with your sight loss. There is some evidence of improved quality of life following visual rehabilitation, but there is a need for high-quality evidence regarding the effectiveness of low vision rehabilitation services. This study will consider whether support from a Rehabilitation Officer for the Vision Impaired makes a difference on the quality of life of individuals experiencing vision loss.
Who can participate?
People aged over 18 in the Cardiff area with low vision who have a requirement for low vision rehabilitation
What does the study involve?
There is one visit to the Cardiff School of Optometry which involves answering some general questions about your health and measuring your vision using a letter chart. After that, an appointment will be made for a telephone interview. This involves going through some questionnaires, which include questions about how well you are able to do vision-related activities such as reading and driving, and questions about your health and how you are feeling. You would then be randomly allocated to either receive immediate support from a Rehabilitation Officer for the Vision Impaired, or to the Sight Cymru waiting list to receive rehabilitation support. Six months after the initial telephone interview there is a second phone appointment going through the same questions.
What are the possible benefits and risks of participating?
If you agree to take part in the study you will receive support from a Rehabilitation Officer for the Vision Impaired within 6 months. The results of the study will help identify the impact of rehabilitation work and will influence the support for this work in future. There are no direct risks of participating. One of the questionnaires that is being used in the study may identify depressive symptoms, which may result in being referred to the GP.
Where is the study run from?
This study is being organised by Cardiff University in collaboration with Sight Cymru. Low vision rehabilitation consists of home visits by a Rehabilitation Officer for the Vision Impaired.
When is the study starting and how long is it expected to run for?
October 2014 to October 2015
Who is funding the study?
Cardiff Council and Sight Cymru (UK)
Who is the main contact?
Dr Jennifer Acton
ActonJ@cf.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jennifer Acton
ORCID ID
http://orcid.org/0000-0002-0347-7651
Contact details
Cardiff Centre for Vision Sciences
College of Biomedical and Life Sciences
Cardiff University
Maindy Road
Cardiff
CF24 4HQ
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1377
Study information
Scientific title
Does rehabilitation officer input improve quality of life in individuals with low vision? A pilot study
Acronym
Study hypothesis
The principal question is to determine whether a low vision rehabilitation officer has an impact on quality of life outcome in individuals with low vision.
Ethics approval
School of Optometry and Vision Sciences Research Ethics Audit Committee, Cardiff University, 01/10/2014, ref: 1377
Study design
Exploratory single-masked randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet
Condition
Low vision
Intervention
The intervention is input from a low vision rehabilitation officer. Low vision rehabilitation is defined as an amelioration of the lives of individuals with sight loss by improving functional ability, and other general aspects, e.g. quality of life and psychosocial status.
There will be two arms:
1. Intervention arm: individuals with low vision who receive low vision rehabilitation
2. Control arm: individuals with low vision who are on a waiting list to receive low vision rehabilitation i.e. they have not yet received low vision rehabilitation
Intervention type
Other
Phase
Drug names
Primary outcome measure
Questionnaire outcomes will be recorded at baseline and after 6 months by telephone interview:
1. 48-item Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ-48)
Secondary outcome measures
Questionnaire outcomes will be recorded at baseline and after 6 months by telephone interview:
1. Patient Health Questionnaire (PHQ9)
2. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
3. Adjustment to age-related visual loss scale (AVL-12)
4. Standardised health-related quality of life questionnaire (EQ-5D)
5. UCLA loneliness scale
Overall trial start date
01/06/2014
Overall trial end date
01/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. A requirement for low vision rehabilitation
2. Distance visual acuity of 6/12 or worse; and/or near acuity of N6 or worse; or significant contraction of the visual field
3. Age 18 years or over
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70
Participant exclusion criteria
1. Live in area outside catchment of rehab officer
2. Ineligible for rehab officer
3. Those with significant need (fast track waiting list)
4. A score of <27/30 on the MMSE
5. Unable to use telephone e.g. caused by very poor hearing
6. Unable to understand English
7. Unable to take part in 6-month study
8. Unable to provide informed consent
9. Previous recipient of low vision rehabilitation via a rehabilitation officer within the last 12 months and no relevant change in circumstances
Recruitment start date
16/10/2014
Recruitment end date
16/10/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cardiff Centre for Vision Sciences
College of Biomedical and Life Sciences
Cardiff University
Maindy Road
Cardiff
CF24 4HQ
United Kingdom
Funders
Funder type
Government
Funder name
Sight Cymru
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cardiff Council
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Welsh Government
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26908153
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27930779