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

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. This study will 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 will be invited to take part. All permanent residents of participating care homes will then be 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?
We will look at walking, balance, memory and mood as well as take a blood test at the start of the study and again, 6 months later. Half of the care homes involved will be chosen at random to get the intervention, the other half will continue to receive 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?
The study is run from King’s College Hospital in London (UK).

When is the study starting and how long is it expected to run for?
The study started in February 2013 and is expected to last 18 months.

Who is funding the study?
The study is funded by a Research for Patient Benefit grant from the National Institute for Health Research (UK).

Who is the main contact?
Julie Whitney
Tel.: 020 3299 3420

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 mult-ifactorial 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.

We have designed a multi-factorial intervention to address falls risk factors specific to those with cognitive impairment living in care homes and will test this in a pilot cluster randomised controlled trial.

We will recruit 212 residents from 6 care homes and randomise 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.

We will collect data 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. We will also collect information 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.

More details can be found at:

Ethics approval

Camberwell St Giles Research Ethics Committee, 13th August 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 below to request a patient information sheet


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


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.
1. Comprehensive geriatric assessment; Timepoint(s): Baseline and at 6 months
2. Management of dementia related behaviours; Timepoint(s): Baseline and at 6 months

Intervention type



Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Living in the selected care home as a permanent resident
Care homes local to Kings 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

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes