Plain English Summary
Background and study aims
Visual impairment is identified as a risk factor for falls. Previous research in New Zealand has shown that home safety improvement and exercise programmes help people over 75 with visual impairment to reduce falls and falls related injuries. However, in the NZ study over half of the people made their homes as safe as possible and only 19% exercised for more than twice a week as directed. Compliance is required as those who did manage to complete the programme were shown to have fewer falls. The aims of this study are to assess the acceptability of the programme, the feasibility of carrying out a large scale study in the NHS, the uptake and long term use of two exercise programmes to reduce falls and falls-related injuries.
Who can participate?
Visually impaired people aged over 75 took part in this study.
What does the study involve?
The participants were randomly allocated to receive one of three treatments: usual care, home safety programme or home safety programme plus home exercise programme for six months. Falls and injuries related to fall were analysed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The study was run from Manchester Royal Eye Hospital and Central Manchester University Hospitals NHS Foundation Trust (UK).
When is the study starting and how long is it expected to run for?
July 2011 to December 2012
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof. Heather Waterman
heather.waterman@manchester.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Heather Waterman
ORCID ID
Contact details
School of Nursing
Midwifery & Social Work
Coupland III
Oxford Road
Manchester
M13 9PL
United Kingdom
-
heather.waterman@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10883
Study information
Scientific title
A pilot study to promote adherence to two interventions to prevent falls in older people with visual impairment
Acronym
VIP2UK
Study hypothesis
To assess the acceptability of interventions to reduce the risk of falls and to assess the feasibility of carrying out a full scale randomised controlled trial (RCT) within the NHS
Objectives:
1. To adapt home safety and home based exercise programme for older people with sight impairment
2. To determine the willingness of clinicians to identify and introduce the study to potential participants, and the rate of recruitment and attrition
3. To monitor the response rate to follow-up assessments of primary and secondary outcomes measures
4. To estimate the variability of outcome measures and statistical parameters needed to calculate sample size in a definitive trial
5. To investigate adherence rate to the HS modifications and HE programmes
6. To explore the resource implications and costs of the interventions, and conduct a preliminary cost effectiveness analysis
Ethics approval
Lancaster Research Ethics Service; 29/03/2011; 11/NW/0038
Study design
Randomised; Interventional; Design type: Not specified, Prevention
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Primary Care, Ophthalmology; Subtopic: Not Assigned, Eye (all Subtopics); Disease: All Diseases, Other
Intervention
Participants were randomly allocated to one of three groups:
1. (Control) received usual care and social visits from a volunteer lay person
2. (Experimental 1) received the Home Safety (HS) programme implemented by an Occupational Therapist
3. (Experimental 2) received the HS plus the home exercise programmes both implemented by the OT and supported by a volunteer peer mentor.
An amended version of the Westmead Home Safety Assessment for those with severe VI was used to assess the physical and environmental home hazards of participants.
The OTAGO exercise programme also amended for people with severe VI was employed comprising leg muscle strengthening and balance retraining exercises. A walking plan was also agreed, if walking was considered safe, undertaken for 6 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Falls recorded in Falls Calander over six months
Secondary outcome measures
Falls related injuries measured by Falls Calendar
Overall trial start date
29/07/2011
Overall trial end date
01/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Vision related inclusion criteria:
1. Binocular visual acuity less than 0.6 LogMAR (Snellen equivalent 6/24), stratified into (i) 0.61.0 LogMAR(1.0 LogMar = Snellens 6/60), (ii) less than 1.0 LogMAR and/or
2. Moderate visual field loss, defined as affecting more than 20% of the test location used in a binocular Estermann
test, stratified into (i) those missing 2050%
of the test locations, (ii) those missing >50% of the test locations.
Other inclusion criteria:
1. Aged 75 years and over
2. Independent community dwelling
3. Able to walk around their own residence
4. Cognitively able to participate in the programme
5. Able to understand the study requirements
Carers
To have a relative or friend who is 75 years or older and with a visual impairment and to have the baility to able to communicate in a group
Peer mentors
Planned inclusion/exclusion criteria for peer mentors:
1. Peer mentors must be physically active
2. 65 or older
3. Cognitively intact
4. Willing to have CRB/Disclosure
5. Willing to engage with 35 patients with visual impairment
6. Undertake home visits throughout ten months
7. They must be volunteers who live locally
8. Willing to travel to people's homes
9. Willing to be trained using the Senior Peer Mentor Physical Activity Programme for Older People.
Occupational therapists
Planned inclusion criteria:
1. To have experience of working with older patients with visual impairments
2. Be willing to go under a CRB check and to supervise peer mentors
3. To have excellent interpersonal skills
4. Ability to work within a team and independently
5. Willing to travel to people's homes
Participant type
Mixed
Age group
Senior
Gender
Both
Target number of participants
Planned Sample Size: 193; UK Sample Size: 193
Participant exclusion criteria
1. Receiving an OT or physiotherapist intervention or home assessment and modification or exercise intervention eg. Falls Clinic.
2. Cognitive impairment assessed by the Abbreviated Mental Test (26) which is a quick and reliable measure suitable for identifying patients who ought to be excluded from the study.
3. Carers, peer mentors and Ots Not meeting inclusion criteria above
Recruitment start date
29/07/2011
Recruitment end date
01/12/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Manchester
Manchester
M13 9PL
United Kingdom
Funders
Funder type
Government
Funder name
NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0909-20090; Thomas Pocklington Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27671540