Condition category
Nervous System Diseases
Date applied
15/12/2016
Date assigned
20/01/2017
Last edited
24/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Dementia is a common condition in the aging population. People with dementia have difficulties with mental processes such as memory, language, reasoning and identifying people and objects, which become progressively worse over time. Dementia with Lewy Bodies (LBD) and Parkinson’s disease Dementia (PDD) together are known as Lewy Body Dementia (LBD). They share common clinical features and biology, and also respond to similar approaches to management. Currently there is evidence that LBD is often not recognised or managed properly, even in specialist hospital services. The signs and symptoms of LBD can be very hard to detect. Ensuring appropriate management of dementia is central to improving care for patients. At the moment there is no simple tool that includes the full range of LBD symptoms, and no real evidence based management care pathway. Currently there is not enough information to say if any one method used by doctors is better than the others for effective patient management. This study is looking at a newly developed management toolkit, which has been designed to help services to better manage LBD patients. The aim of this study is to compare usual management methods and the new management toolkit in order to evaluate the effect of the toolkit on patient symptoms, outcomes, quality of life and carer stress.

Who can participate?
Patients aged 60 years and over with LBS

What does the study involve?
Participating services are randomly allocated to one of two groups. Services in the first group continue to manage their patients in the usual way, which may vary from service to service. Services in the second group are provided with the management toolkit and encouraged to use this as and when appropriate with all of their patients. The management toolkit is a recommended guideline and can be used according to clinician judgment, either on a single visit or on multiple visits. In both groups, patients and carers attend hour and a half-long visits at the start of the study and then after three and six months. Each visit involves the patient completing a number of questionnaires with a qualified assessor. The carer/informant then seperately completes a number of questionnaires relating to both themselves and the patient.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved to those participating.

Where is the study run from?
21 NHS dementia services in East Anglia and the North East of England (UK)

When is the study starting and how long is it expected to run for?
September 2015 to February 2019

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

Who is the main contact?
Ms Sarah Dunn
sarah.dunn2@newcastle.ac.uk

Trial website

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

Contact information

Type

Public

Primary contact

Ms Sarah Dunn

ORCID ID

Contact details

Newcastle Clinical Trials Unit
1-4 Claremont Terrace
Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom
+44 191 208 2521
sarah.dunn2@newcastle.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

30476

Study information

Scientific title

Improving the diagnosis and management of neurodegenerative dementia of Lewy body type in the NHS.
Work Package 5A and 5B: A pilot cluster randomised study of the management toolkit in the NHS secondary care services

Acronym

DIAMOND-Lewy

Study hypothesis

The aim of this study is to see if a newly developed management toolkit will result in symptom improvement, increased quality of life and decreased carer stress in patients with Lewy Body Dementia (LBD).

Ethics approval

West Midlands – Coventry and Warwickshire REC, 17/02/2016, ref: 16/WM/0025

Study design

Randomised; Interventional; Design type: Process of Care, Management of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

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

Specialty: Dementias and neurodegeneration, Primary sub-specialty: Dementia; UKCRC code/ Disease: Neurological/ Other degenerative diseases of the nervous system

Intervention

Services are randomised to receive either the management toolkit (interventional sites) or to continue their usual management of the patients (control sites). The management toolkit is a recommended guideline and will be used according to clinician judgment in the intervention arm. It could be used at a single visit only, or over multiple visits/patient contacts across several months. The management toolkit will be used as part of routine practice and will remain with sites after the end of the study. Additional study visits will be conducted at baseline, 3 months and 6 months, and clinicians in the intervention arm will be asked to complete a clinician toolkit use questionnaire.

The patient and carer will take part in 3 visits (baseline, 3 and 6 months) which will take place at their home over a 6 month period. Each visit will take approximately 1 hour 30 minutes. Each visit involves the patient completing a number of questionnaires with a qualified assessor. The carer/informant will separately complete a number of questionnaires relating to both themselves and the patient. If both the patient and carer can be present, 2 members of the team will conduct the visit when possible. The final study visit will be done at 6 months (+/- 2 weeks) after the baseline visit. This will be the end of the study for patients and carers/informants.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Feasibility of use of the intervention is assessed by Clinician Toolkit Feedback Questionnaire at approximately 6 months after service has been randomised and at the end of the trial.
2. Impact of the assessment and management toolkit on patient management, health outcomes, and its impact on informants/carers is assessed by this is assessed through collection of outcome measured at baseline, 3 and 6 months
3. Cost-effectiveness of the new assessment and management toolkit for LBD with usual care is assessed by this is assessed by the Use of services and costs Questionnaire at Baseline, 3 months and 6 months and Time and Travel Questionnaire at 6 months as listed below

Secondary outcome measures

1. Symptom severity is measured using the reduced Neuropsychiatric Inventory (NPI) score; lower unified Parkinson’s disease rating scale (UPDS) score; Dementia Cognitive Fluctuation Scale (DCFS-R), lower Cornell depression score, Galvin Lewy Body Composite Score and Geriatric Depression Scale at baseline, 3 and 6 months
2. Patient quality of life is measured using the patient EQ-5D-5L and carer proxy EQ-5D-5L; patient DEMQOL and carer DEMQOL-proxy scales at baseline, 3 and 6 months
3. Rates of cognitive decline is measured using the MMSE and MoCA scales at baseline, 3 and 6 months
4. Carer stress and quality of life is measured using the carer EQ-5D-5L; HADS; and Zarit burden scale at baseline, 3 and 6 months
5. Global outcome is measured using the Global outcome Scale at 3 months and 6months.
6. Heath economic measures are measured using the non-standardised questionnaires developed by the research team as follows: Time and Travel Questionnaire at 6 months and Use of services and costs Questionnaire at Baseline, 3 months and 6 months

Overall trial start date

22/09/2015

Overall trial end date

01/02/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. A clinician diagnosis of LBD has been documented as the result of specialist service assessment (possible or probable diagnosis)
2. Consent can be obtained from the patient or, for those subjects lacking capacity, from a consultee

In addition to the above criteria:
WP5A: Patients aged 60 and over with at least 1 active clinical issue as determined by the treating clinical team.
WP5B: Patients aged 60 and over with a diagnosis of Parkinson’s disease where a memory problem has developed.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

Participant exclusion criteria

1. Patients who have explicitly expressed a wish not to be approached to take part in research
2. Patients who have been approached to take part in this study previously (as part of another participating service)
3. Patients who have a severe or terminal illness and reduced life expectancy which compromises their ability to comply with the protocol
4. Insufficient English to allow completion of the study measures
5. Patients who are assessed as not able to complete the outcome measures for the study. Clinicians may choose not to use the management tool at some assessments if they feel it is not appropriate.

Recruitment start date

22/04/2016

Recruitment end date

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newtown Centre
Nursery Road
Huntingdon
PE29 3RJ
United Kingdom

Trial participating centre

Peterborough Memory Clinic
Dementia Resource Centre 441 Lincoln Road Millfield
Peterborough
PE1 2PE
United Kingdom

Trial participating centre

Specialist Dementia and Frailty Service
Western House Chapel Hill
Stansted
CM24 8AG
United Kingdom

Trial participating centre

Cambridge Memory Clinic
Deighton Centre Ida Darwin Cambridge Road
Fulbourn
CB21 5EE
United Kingdom

Trial participating centre

Julian Hospital
Bowthorpe Road
Norwich
NR23 TD
United Kingdom

Trial participating centre

Chatterton House
Goodwins Road
King's Lynn
PE30 5PD
United Kingdom

Trial participating centre

Gateway House
Farrier Close
Wymondham
NR18 0WF
United Kingdom

Trial participating centre

Wedgewood House
West Suffolk Hospital Hardwicke Lane
Bury St Edmunds
IP33 2QZ
United Kingdom

Trial participating centre

Elderly Medicine Movement Disorder Clinic
Norfolk & Norwich University Hospitals NHS Foundation Trust Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

West Suffolk Hospital
Hardwick Lane
Bury St Edmunds
IP33 2QZ
United Kingdom

Trial participating centre

Tracey Ward Disability resource Centre
Unit 4 Bunting Road
Bury St Edmunds
IP32 7BX
United Kingdom

Trial participating centre

The Priory Memory Clinic
Hawkeys Lane
North Shields
NE29 0SF
United Kingdom

Trial participating centre

Jubilee Day Hospital
Parkinson’s Service North Tyneside General Hospital
North Shields
NE29 8NH
United Kingdom

Trial participating centre

North Tyneside Hospital
MHSOP
North Shields
NE29 8NH
United Kingdom

Trial participating centre

Northumberland Community Services
Older Persons Service Community Care Group Hexham General Hospital
Hexham
NE36 1QJ
United Kingdom

Trial participating centre

Older People’s Mental Health Services
West Wing St George’s Park
Morpeth
NE61 2NU
United Kingdom

Trial participating centre

Monkwearmouth Hospital
Memory Protection Service 1st Floor Newcastle Road
Sunderland
SR5 1NB
United Kingdom

Trial participating centre

Castleside Day Unit
Centre for Health of the Elderly Campus for Ageing & Vitality Westgate Road
Newcastle-Upon-Tyne
NE4 6BE
United Kingdom

Trial participating centre

CRESTA Clinic
Biomedical Research Building Campus for Ageing & Vitality Westgate Road
Newcastle-Upon-Tyne
NE4 6BE
United Kingdom

Trial participating centre

Campus for Ageing and Vitality
Belsay Unit Westgate Road
Newcastle upon Tyne
NE4 6BE
United Kingdom

Trial participating centre

Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom

Sponsor information

Organisation

Northumberland, Tyne and Wear NHS Foundation Trust

Sponsor details

St. Nicholas Hospital
Jubilee Road
Gosforth
Newcastle upon Tyne
NE3 3XT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The plan will be to publish within 6 months of the end of trial date.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/08/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/10/2017: The registration of this study was requested through the NIHR Portfolio. The trialist confirmed the recruitment start and end dates. 22/09/2017: Internal review.