Developing an intervention for fall related injury in dementia

Plain English summary of protocol

Background and study aims
People with dementia (PWD) fall over more often than people who do not have dementia. When they fall over, they are more likely to hurt themselves. They do not get better as easily as people without dementia. After hurting themselves PWD may need a lot more help in looking after themselves. They may need to move to a care home. They and their carer may not have such a good quality of life after the fall. The NHS and social services find it is expensive to look after people with these injuries. We know that injuries cause many problems for PWD, but we do not really know the best way to look after them. This is because there are very few examples of research in this area. Each person is likely to have many different needs, but at the moment, we do not know what these needs are, or how we can meet these needs within the NHS. For instance, would it be better to have a specialist team to look after PWD who fall, or would it be better to invest in education for all staff looking after PWD in the community? We also do not know what is most important to PWD after a fall. For instance, is it more important that they can start walking quickly, or do they need to feel confident that they will not fall again? However we approach this problem, it is important to show that the approach actually works and is good value for money. We do this by carrying out a clinical trial. In this study, we plan to do the background research needed to make sure that we design a trial that has a good chance of being successful.

Who can participate?
People with dementia who live in the community and who have sustained a fall-related injury, and the carers and professionals who care for them.

What does the study involve?
In the first part of the study, the researchers search for previous studies to find out what PWD need after a fall. In the second part of the study, the researchers keep a record of every PWD who sees their GP, calls an ambulance or goes to hospital because they have hurt themselves in a fall in Newcastle, Stockton and Norwich. They check these people’s records to find out if they were kept in hospital or referred to a clinic. They ask some people in each place to keep a detailed diary of all the help they had from the NHS and social services. They then ask if we can interview them and their carers to find out what help they needed after the fall. In the third part of the study, the researchers ask a group of experts, PWD and their carers to look at the things they found out in the first two parts of the study. They ask them whether they think it is likely that they will find enough people to take part in a clinical trial and where it would be best to do it. For example, should they ask the ambulance staff to find the PWD for the trial, or should they do it at the hospital? They ask them about what sort of help people would need and how they should measure whether the PWD got better. In the fourth part of the study, the researchers practice doing the things that the expert group decided they should do. This is with just 15 people in each town and is a practice to smooth out any problems before doing the full trial. The aim is to find out how to cope with any practical problems that would make the trial difficult. They also ask the PWD, their carers and the staff looking after them whether they had any problems taking part.

What are the possible benefits and risks of participating?
At the end of the study, we will be able to say whether it is a good idea to have a full clinical trial of how to improve what happens for PWD who hurt themselves in a fall. If it is, we will be able to recommend how the trial should be done.

Where is the study run from?
Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
June 2015 to August 2018

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

Who is the main contact?
Dr Louise Allan (louise.allan@ncl.ac.uk)
Mrs Beth Edgar (beth.edgar@ncl.ac.uk)

Contact information

Dr Louise Allan
Scientific

Institute of Neuroscience
Newcastle University
Biomedical Research Building
Campus for Ageing and Vitality
Newcastle upon Tyne
NE4 5PL
United Kingdom

ORCID ID	0000-0002-8912-4901
Phone	+44 (0)191 208 1336
Email	louise.allan@ncl.ac.uk

Mrs Beth Edgar
Public

Institute of Neuroscience
Newcastle University
Biomedical Research Building
Campus for Ageing and Vitality
Newcastle upon Tyne
NE4 5PL
United Kingdom

Phone	+44 (0)191 208 1314
Email	beth.edgar@ncl.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England

Study participating centres

Results and Publications

Study outputs

Editorial Notes

29/11/2022: Publication reference added.
30/10/2019: Publication reference added.
17/09/2019: The intention to publish date was changed from 31/08/2019 to 31/12/2019.
16/09/2019: Total final enrolment number added.
21/11/2018: Publication reference added.
14/08/2018: IPD sharing statement added.
03/08/2018: The recruitment end date was changed from 30/04/2018 to 31/07/2018.
06/02/2018: The overall trial end date has been updated from 31/07/2018 to 31/08/2018. The recruitment end date has been updated from 28/02/2017 to 30/04/2018. The intention to publish date has been updated from 31/07/2017 to 31/08/2019.
04/08/2017: Trial end date has been updated from 31/07/2017 to 31/07/2018.
30/03/2016: Ethics approval information added and the availability of the participant level data has been updated.