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

ISRCTN ISRCTN15342873
DOI https://doi.org/10.1186/ISRCTN15342873
Secondary identifying numbers 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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study acronymVIP Falls Prevention Trial
Study objectivesStudy 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) studiedFalls in elderly people
Intervention1. Home environment programme
2. Home exercise programme
3. Both home environment and exercise programmes
4. Social visits
Intervention typeOther
Primary outcome measureFalls and injuries resulting from falls.
Secondary outcome measures1. 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 study start date01/10/2002
Completion date31/10/2004

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants391
Key inclusion criteria1. Community living women and men aged 75 years and older
2. Visual acuity 6/24 metres or less
Key exclusion criteria1. Cannot walk around their own residence
2. Receiving physiotherapy at the time of recruitment
3. Cannot understand the trial requirements
Date of first enrolment01/10/2002
Date of final enrolment31/10/2004

Locations

Countries of recruitment

  • New Zealand

Study participating centre

Department of Medical and Surgical Sciences
Dunedin
9001
New Zealand

Sponsor information

Health Research Council of New Zealand (New Zealand)
Research council

PO Box 5541
Wellesley Street
Auckland
1001
New Zealand

Phone +64 (0)9 379 8227
Email info@hrc.govt.nz
Website http://www.hrc.govt.nz/
ROR logo "ROR" https://ror.org/00zbf3d93

Funders

Funder type

Research council

Health Research Council of New Zealand (New Zealand) (ref: 02/265)
Government organisation / National government
Alternative name(s)
HRCNewZealand, HRC New Zealand, HRC
Location
New Zealand

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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