Condition category
Mental and Behavioural Disorders
Date applied
11/09/2014
Date assigned
11/09/2014
Last edited
11/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Changes in the behaviour of people with dementia are very common, and usually get worse as the disease progresses. More than half of patients with dementia who are living in care homes regularly experience feelings of agitation. There is evidence to show that these feelings can be linked to a lower quality of life for the patient, as well as higher care costs compared to patients who are not agitated. Although agitation is common in dementia patients, many staff in care homes are not trained to deal with these behaviours. The aim of this study is to find out whether introducing new training practices in care homes to help deal with agitated patients can help to improve their quality of life and lower levels of agitation.

Who can participate?
1. Care homes with at least 17 patients with dementia who will allow training sessions for the study.
2. Paid carers who provide face-to-face care for people with dementia.
3. Patients with a diagnosis of dementia
4. Family members of patient with dementia involved in the study who see their relatives at least once a month.

What does the study involve?
Staff and managers in care homes are interviewed in order to find out the main things that help and hinder changes in policies. This information is then used in the development of a programme for the care homes. Paid carers are then trained, using the manual, to reduce agitation in patients with dementia, as well as prevent new cases of agitation from developing. After 8 months, a questionnaire (Cohen-Mansfield Agitation Inventory) is completed in order to assess the levels of agitation in the residents.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Charles Bell House, University College London (UK)

When is the study starting and how long is it expected to run for?
July 2014 to September 2018

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

Who is the main contact?
Ms Debbie Livingston
d.livingston@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sian Cousins

ORCID ID

Contact details

Division of Psychiatry
University College London
6th Floor
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
+44 20 7679 9324
sian.cousins@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17341

Study information

Scientific title

The MARQUE project: Managing Agitation and Raising QUality of Life: Cluster RCT to improve agitation for people with dementia in care homes

Acronym

MARQUE

Study hypothesis

Our manual based intervention and strategy for changing care home culture decrease the mean level of agitation (measured by Cohen-Mansfield Agitation Inventory; CMAI) in residents with dementia eight months later, compared with usual practice?

Ethics approval

London - Queen Square Research Ethics Committee, 02/10/215, ref: 14/LO/0697

Study design

Multi-centre randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Dementia

Intervention

Care homes are randomly allocated to one of two groups.

Intervention group: Staff take part in the manual based training package to teach staff in care home about managing agitation in dementia. This involves all day staff who are involved in personal care of residents from Managers down taking part in 6, 2 hours group sessions over 12 weeks. The intervention sessions will follow a manual with practical homework. Supervision sessions for care home staff will be available following training.

Control group: Staff will continue with their TAU training, we expect the TAU to be similar to good “TAU” throughout the UK

Eight months from baseline, follow up assessments will be carried out in both groups.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Cohen-Mansfield Agitation Inventory (CMAI) total is measured at 8 months.

Secondary outcome measures

1. Cost effectiveness in terms of agitation (CMAI) is measured at 8 months
2. Cost effectiveness in terms of QALYS is measured at 8 months
3. Quality of life of residents in the intervention group compared to the control group is measured at 8 months
4. Reducation in clinically significant agitation(CMAI>45)in intervention group compared to control group is measured at 8 months
5. Reduction in neuropsychiatric symptoms overall in intervention group compared to control group is measured at 8 months

Overall trial start date

17/07/2014

Overall trial end date

01/09/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Care homes inclusion criteria:
1. The minimum number of residents required for a home’s inclusion in the study have dementia (17)
2. Care home is willing to be randomised
3. Care home will commit to allow mandatory training sessions, training staff champions to continue implementation (two per home to take account of possible staff turnover) and changing management procedures, to integrate the new techniques into care
4. Care home will commit to approaching residents and relatives
5. No plans to close over the following year

Inclusion criteria for paid carers:
1. Paid carer who provides face to face care for residents, at least some of whom have dementia.
2. Carer willing to complete the questionnaires about residents with dementia whom they know well
3. Carer willing to answer questions about their own coping

Inclusion criteria for residents with dementia:
1. Dementia diagnosis according to Noticeable Problems Checklist or known dementia diagnosis

Inclusion criteria for family carer:
1. Identifies themselves as the primary family carer for a resident in the home who either consents to the study or if the resident does not have capacity to consent to the study then the family carer has agreed that they will be in the study
2. See their relative with dementia at least monthly

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 340; UK Sample Size: 340

Participant exclusion criteria

Exclusion criteria for care homes:
Less than 70% of the staff consent to the study after the care home manager has agreed to the study but before randomisation.

Recruitment start date

17/07/2014

Recruitment end date

01/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Charles Bell House
67-73 Riding House Street
London
W1W 7EJ
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (ESCR/NIHR) (UK); Grant Codes: ES/L001780/1

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

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

11/01/2015: The interventions section has been updated to include further information about the control group and intervention group methodology, which was not originally included in the record.