Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Falls are a common and serious problem for older people living with dementia, particularly those who live in care homes. Not enough is known about the best ways to prevent falls in those living in care homes. The aim of this study is to investigate whether an assessment followed by an individualised plan of care and therapy is effective in reducing falls.

Who can participate?
The managers of care homes in South East London are invited to take part. All permanent residents of participating care homes are then asked if they wish to participate. If a resident has difficulty making the decision, relatives may be asked to help with this.

What does the study involve?
Walking, balance, memory and mood are assessed and a blood sample is taken at the start of the study and again 6 months later. The care homes are randomly allocated to either deliver the intervention or to continue to deliver care as normal. The intervention involves an assessment of factors which may increase the chance of falling and making recommendations for each person. These may include exercise, occupational therapy and review of medications.

What are the possible benefits and risks of participating?
Those who receive the intervention may find that their walking and balance improve, they feel better and have fewer falls. The risks are small: the blood test may be uncomfortable and it is possible to lose balance while doing the exercises. However, the physiotherapists providing exercise will supervise the exercise closely to minimise this risk.

Where is the study run from?
King’'s College Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2012 to April 2014

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Julie Whitney

Trial website

Contact information



Primary contact

Ms Julie Whitney


Contact details

Clinical Age Research Unit
Denmark Hill
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Prevention of falls in cognitively impaired older adults living in residential care (PROF-COG). A pilot multi-factorial intervention to prevent falls in older people living in care homes tailored towards risk factors related to cognitive impairment



Study hypothesis

Falls are a serious public health problem. The resultant injuries put immense strain on public resources and individuals who fall often go on to suffer difficulties with mobility, fear of further falls and loss of confidence and independence. Fall prevention trials on care home dwellers have been conflicting possibly because some have failed to adequately consider the effect of dementia in this physically frail population. Falls are twice as common in those with dementia and to date, despite a wealth of evidence to support preventative interventions in the cognitively intact, there have been no effective interventions specifically for those with dementia.

A multi-factorial intervention has been designed to address falls risk factors specific to those with cognitive impairment living in care homes and will be tested in a pilot cluster randomised controlled trial.

Ethics approval

Camberwell St Giles Research Ethics Committee, 13/08/2012, ref: 12/LO/1099

Study design

Randomised; Interventional; Design type: Process of Care

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Dementia; Disease: Dementia


212 residents will be recruited from 6 care homes and randomised by care home into intervention and control groups. All participants will undergo screening to identify known risk factors for falls and appropriate referrals will be made for all participants in the intervention group. Interventions include review by a geriatrician, balance training exercise and management of dementia related behaviours. The control group will receive usual care.

Data will be collected on the clinical efficacy of the intervention in terms of its effect on falls risk factors including measures of balance, mobility, behaviour and quality of life. Information will also be collected to determine the safety, acceptability and feasibility of the intervention to ensure the development of a robust protocol for a future larger trial powered to detect differences in falls and fallers. While this intervention has been designed to address falls, it may have many other beneficial effects such as reduced hospital admissions, health and social care costs.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Standing balance; Timepoint(s): Baseline and at 6 months

Secondary outcome measures

1. Anxiety, assessed using the Goldberg Anxiety Scale at baseline and follow up
2. Cognition, assessed using the Addenbrooke's Cognitive Examination at baseline and follow up
3. Concern over falling, assessed using the Falls Efficacy Scale international at baseline and follow up
4. Physical assessment, including measure of walking (timed up and go), a standing balance test, sit to stand function and grip strength, at baseline and follow up

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Living in the selected care home as a permanent resident
Care homes local to King's College Hospital will be recruited based on nearest first and:
1. Manager's consent to participate
2. Not involved in other interventional research (affecting the majority of residents)
3. Target Gender: Male & Female

Participant type


Age group




Target number of participants

Planned Sample Size: 212

Participant exclusion criteria

1. Refusal to consent
2. Personal or nominated consultee advised against participation
3. Temporary resident in the selected care home
4. Unable to understand enough English to participate

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Clinical Age Research Unit
United Kingdom

Sponsor information


King's College Hospital (UK)

Sponsor details

Paediatric Liver centre
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research (UK) - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0211-24140

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

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

Basic results (scientific)

Publication list

2017 results in:

Publication citations

Additional files

Editorial Notes

05/06/2017: Publication reference added.