Interventions to prevent falls and injury in elderly people with impaired vision
ISRCTN | ISRCTN15342873 |
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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
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 |
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john.campbell@stonebow.otago.ac.nz |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Prevention |
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 | 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 study start date | 01/10/2002 |
Completion date | 31/10/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Both |
Target number of participants | 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
9001
New Zealand
Sponsor information
Health Research Council of New Zealand (New Zealand)
Research council
Research council
PO Box 5541
Wellesley Street
Auckland
1001
New Zealand
Phone | +64 (0)9 379 8227 |
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info@hrc.govt.nz | |
Website | http://www.hrc.govt.nz/ |
https://ror.org/00zbf3d93 |
Funders
Funder type
Research council
Health Research Council of New Zealand (New Zealand) (ref: 02/265)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- HRCNewZealand, HRC New Zealand, HRC
- Location
- New Zealand
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 08/10/2005 | Yes | No |