Interventions to prevent falls and injury in elderly people with impaired vision

ISRCTN	ISRCTN15342873
DOI	https://doi.org/10.1186/ISRCTN15342873
Protocol serial number	02/265
Sponsor	Health Research Council of New Zealand (New Zealand)
Funder	Health Research Council of New Zealand (New Zealand) (ref: 02/265)

Submission date: 02/03/2005
Registration date: 07/03/2005
Last edited: 20/12/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof A John Campbell
Scientific

Department of Medical and Surgical Sciences
University of Otago Medical School
PO Box 913
Dunedin
9001
New Zealand

Phone	+64 (0)3 4747007 ext. 8506
Email	john.campbell@stonebow.otago.ac.nz

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	VIP Falls Prevention Trial
Study objectives	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(s)	Ethics approval received from Otago and Auckland Ethics Committees.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Falls and injuries resulting from falls.
Key secondary outcome measure(s)	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)
Completion date	31/10/2004

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	391
Key inclusion criteria	1. Community living women and men aged 75 years and older 2. Visual acuity 6/24 metres or less
Key exclusion criteria	1. Cannot walk around their own residence 2. Receiving physiotherapy at the time of recruitment 3. Cannot understand the trial requirements
Date of first enrolment	01/10/2002
Date of final enrolment	31/10/2004

Locations

Countries of recruitment

New Zealand

Study participating centre

Department of Medical and Surgical Sciences

Dunedin
9001
New Zealand

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	08/10/2005		Yes	No