Condition category
Injury, Occupational Diseases, Poisoning
Date applied
02/03/2005
Date assigned
07/03/2005
Last edited
20/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.hrc.govt.nz/

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

Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16183652

Publication citations

  1. 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.

Additional files

Editorial Notes