Contact information
Type
Scientific
Primary contact
Prof A John Campbell
ORCID ID
Contact details
Department of Medical and Surgical Sciences
University of Otago Medical School
PO Box 913
Dunedin
9001
New Zealand
+64 (0)3 4747007 ext. 8506
john.campbell@stonebow.otago.ac.nz
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
02/265
Study information
Scientific title
Acronym
VIP Falls Prevention Trial
Study hypothesis
Study objectives:
1. To demonstrate the efficacy of two interventions:
1.1. A strength and balance retraining programme and vitamin D supplements
1.2. A home safety programme, in preventing falls and injuries in people living in the community aged 75 years and over with visual impairment (visual acuity 6/24 or less)
2. To demonstrate the efficacy of the two programmes in improving independence, level of physical activity and quality of life
3. To determine the cost effectiveness of the two interventions in comparison with other falls prevention strategies
4. To determine the vitamin D status in a sample of people 75 years and over with visual impairment and compare this with an age and sex matched control group drawn from the same general practices at the same time
Summary of study design:
We will assess the effectiveness and cost effectiveness of two falls prevention programmes in a randomised controlled trial with one year of follow up. The two interventions will be individually delivered at home:
1. An exercise programme for one year consisting of a set of leg muscle strengthening and balance retraining exercises and a walking plan, modified for use by visually impaired people and individually prescribed by a physiotherapist. Participants in this intervention arm will also receive vitamin D (Calciferol) supplements.
2. An injury prevention programme of home safety assessment and modification designed specifically for visually impaired people and delivered by an occupational therapist.
We will recruit 400 men and women living in the community and aged 75 years and older with visual acuity of 6/24 metres or less. Potential participants will be recruited from low vision clinics at two city hospitals and one university department and from those registered with the Royal New Zealand Foundation for the Blind.
The trial has a two by two factorial design. There will be 100 people randomly allocated to each of four groups:
1. The home exercise programme and vitamin D supplements, plus the home safety programme
2. The home exercise programme and vitamin D supplements
3. The home safety programme
4. A control group with no falls prevention intervention who will receive their usual care and health services, plus social visits.
Falls, injuries and healthcare resource use as a result of falls will be monitored for one year.
Ethics approval
Ethics approval received from Otago and Auckland Ethics Committees.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Falls in elderly people
Intervention
1. Home environment programme
2. Home exercise programme
3. Both home environment and exercise programmes
4. Social visits
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Falls and injuries resulting from falls.
Secondary outcome measures
1. Self perceived health status (36-item short form health survey [SF-36])
2. Fear of falling
3. Physical activity level (human activity profile)
4. Visual disability (VF-14)
5. Mobility and physical independence (Nottingham extended activities of daily living [ADL])
6. Muscle strength and balance (4-test balance scale, chair stand test)
7. Use of health care resources as a result of falls and injuries
8. The incremental costs and cost effectiveness of delivering each intervention (if the intervention is effective in reducing falls)
Overall trial start date
01/10/2002
Overall trial end date
31/10/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Community living women and men aged 75 years and older
2. Visual acuity 6/24 metres or less
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
391
Participant exclusion criteria
1. Cannot walk around their own residence
2. Receiving physiotherapy at the time of recruitment
3. Cannot understand the trial requirements
Recruitment start date
01/10/2002
Recruitment end date
31/10/2004
Locations
Countries of recruitment
New Zealand
Trial participating centre
Department of Medical and Surgical Sciences
Dunedin
9001
New Zealand
Sponsor information
Organisation
Health Research Council of New Zealand (New Zealand)
Sponsor details
PO Box 5541
Wellesley Street
Auckland
1001
New Zealand
+64 (0)9 379 8227
info@hrc.govt.nz
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Health Research Council of New Zealand (New Zealand) (ref: 02/265)
Alternative name(s)
HRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
New Zealand
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
Results - basic reporting
Publication summary
Publication citations
-
Results
Campbell AJ, Robertson MC, La Grow SJ, Kerse NM, Sanderson GF, Jacobs RJ, Sharp DM, Hale LA, Randomised controlled trial of prevention of falls in people aged > or =75 with severe visual impairment: the VIP trial., BMJ, 2005, 331, 7520, 817, doi: 10.1136/bmj.38601.447731.55.