Condition category
Mental and Behavioural Disorders
Date applied
16/11/2015
Date assigned
16/11/2015
Last edited
30/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 July 2017.

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)

Trial website

http://research.ncl.ac.uk/difrid

Contact information

Type

Scientific

Primary contact

Dr Louise Allan

ORCID ID

http://orcid.org/0000-0002-8912-4901

Contact details

Institute of Neuroscience
Newcastle University
Biomedical Research Building
Campus for Ageing and Vitality
Newcastle upon Tyne
NE4 5PL
United Kingdom
+44 (0)191 208 1336
louise.allan@ncl.ac.uk

Type

Public

Additional contact

Mrs Beth Edgar

ORCID ID

Contact details

Institute of Neuroscience
Newcastle University
Biomedical Research Building
Campus for Ageing and Vitality
Newcastle upon Tyne
NE4 5PL
United Kingdom
+44 (0)191 208 1314
beth.edgar@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 13/78/02

Study information

Scientific title

Is it possible to develop a complex intervention to improve the outcome of fall-related injuries in people with dementia?

Acronym

DIFRID

Study hypothesis

The overall aim of this study is to assess through a series of work packages (WPs) whether it is possible to design a complex intervention to improve the outcome of fall-related injuries in people with dementia living in their own homes.
The health technology to be assessed in this project is a complex intervention and is at the earliest stage of development described in the MRC guidance on developing and evaluating complex interventions. People with dementia who sustain fall-related injuries currently receive a range of health interventions, but a single model of care in the form of a complex intervention for this specific situation has not previously been described and the potential demand for such an intervention is not known. We have taken the approach that in order to develop a new, person-centred and effective complex intervention for this group of patients, we must first be able to answer the following research questions.
1. What are the health and social care needs of patients and carers which must be addressed by the complex intervention?
2. What is the likely demand for the complex intervention?
3. What are the health and social care interventions already being received by patients and carers (i.e., what is usual care)?
4. What are the best available ideas for a new complex intervention (from the perspectives of all stakeholders)?
5. What are the outcomes of importance which the complex intervention must influence (from the perspectives of all stakeholders)?
6. How should changes in these outcomes be measured with respect to clinical effectiveness and cost-effectiveness and have these been measured in any previous studies?

More details can be found here: http://www.nets.nihr.ac.uk/projects/hta/137802

Ethics approval

Service observation:
North East: Newcastle and North Tyneside 2 Research Ethics Committee, 22/01/2016, ref: 15/NE/0397

Main study:
North East: Newcastle and North Tyneside 2 Research Ethics Committee, 22/03/2016, ref: 16/NE/0011

Study design

Observational longitudinal study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Improving the outcomes of fall-related injuries in dementia

Intervention

This is a feasibility study which aims to design and test the feasibility of a complex intervention

Work package 1: We will use established methods of systematic review to identify empirical evidence regarding the health and social care needs of people with dementia with fall-related injuries, outcomes of importance to patients, carers and professionals and comparative studies providing evidence on the relative effectiveness and cost effectiveness of interventions.

Work package 2: We will use both quantitative and qualitative methods in an observational study, which will describe current models of usual care and identify how the models might be adapted in a complex intervention package.

Work package 3: We will convene a consensus panel to review the findings of the prior work packages. The recommendations of the panel regarding the design of the intervention will be assimilated using methods of the RAND Nominal Group Technique (NGT-R, also known as the modified Delphi panel approach).

Work package 4: We will test the procedures for implementation of the intervention and measurement of outcomes recommended in WP3, in the form of a pre-trial evaluation. We will test the feasibility of delivery of the intervention within present NHS structures, and test acceptability, adherence to delivery of the intervention and outcome measurement.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

The establishment of the best primary outcome measure for this group of patients is one of the research questions

Secondary outcome measures

The establishment of the best secondary outcome measures for this group of patients is one of the research questions

Overall trial start date

01/06/2015

Overall trial end date

31/07/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. People with a known diagnosis of dementia who live in the community, and who present to health services having sustained a fall-related injury
2. People who care for those with a known diagnosis of dementia who live in the community, and who present to health services having sustained a fall-related injury
3. Professionals who care for those with a known diagnosis of dementia who live in the community, and who present to health services having sustained a fall-related injury

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Work package 2: 117 , Work package 3: 33, Work package 4: 70

Participant exclusion criteria

1. Not living in the community
2. The diagnosis of dementia cannot be established within 72 hours

Recruitment start date

01/11/2015

Recruitment end date

28/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle upon Tyne Hospitals NHS Trust
Biomedical Research Building Campus for Ageing and Vitality
Newcastle upon Tyne
NE4 5PL
United Kingdom

Trial participating centre

North Tees and Hartlepool NHS Foundation Trust
TS19 8PE
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospitals NHS Foundation Trust
NR4 7UY
United Kingdom

Sponsor information

Organisation

Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Level 1
Regent Point
Regent Farm Road
Gosforth
Newcastle upon Tyne
NE3 3HD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Our communication plan is designed to achieve maximum impact for our work among clinicians, patient groups and researchers, and so in addition to academic channels we will partner with the Alzheimer’s Society and Dementia UK to develop the public/patient message. This has been critical in our previous projects in the field. We will set up a study website which will summarise the WPs to be undertaken and provide public information regarding their progress and findings.
For patients and members of the public, we will produce a programme newsletter which will be made available to participants, uploaded to the study website and made available in newsletters provided by voluntary organisations (Alzheimer’s Society, Age UK). We will present our findings at DeNDRoN PPI groups and local PPI groups.
For researchers and professionals, the systematic reviews in WP1 will be registered on the PROSPERO database of systematic reviews and progress will be reported on the website. We will also use our multidisciplinary links to publicise the findings on relevant professional websites (e.g. the British Geriatrics Society). Further links will be established as part of the WP1, where we will surveying current practice. We will disseminate the results of our study to identified links and signpost them to our website. The findings of each WP will be presented at scientific meetings and published in peer-reviewed journals. We will target open access publications to maximise availability. We will aim to present at two conferences, for example at the BGS and American Geriatric Association meetings.
For policy makers and commissioners, we will publish articles in appropriate periodicals and journals and provide signposting to our website. We will use our links in the Dementia Action Alliance and other voluntary organisations to identify key policy groups.
Social media - we will use Twitter to provide relevant details of any new publication, website update or new blog that the project completes. To gauge feedback, we will send a tweet that links to a research blog and ask our followers for their feedback and comments. Our university media department's Twitter will be part of our communication package.
Finally, the findings of the research will be reported in the NIHR HTA Journal, describing whether it has been possible to design an intervention which may improve outcomes for community dwelling PWD with fall-related injuries. If it has been possible to design such an intervention, we will describe how recipients should be identified, describe and manualise the key components of the intervention, recommend how and where it should be delivered, and by whom. We will describe the learning needs of the professionals delivering the intervention and produce appropriate educational materials.

Intention to publish date

31/10/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/03/2016: Ethics approval information added and the availability of the participant level data has been updated.