Condition category
Mental and Behavioural Disorders
Date applied
18/03/2015
Date assigned
20/03/2015
Last edited
20/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sarah Butchard

ORCID ID

Contact details

Mersey Care NHS Trust
Community Services Dept
Mossley Hill Hospital
Liverpool
L18 8BU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18379

Study information

Scientific title

Embedding a Human Rights Based Approach to Dementia Care

Acronym

Study hypothesis

The study will employ a randomised controlled trial (RCT) design to explore the research question: Does the application of a Human Rights based approach lead to improvements in the care and well-being of people with dementia who are in an inpatient/care home setting? Specifically, the study will evaluate whether the delivery of targeted Human Rights training to staff and the subsequent introduction of a Human Rights Based Care Assessment Tool - " Getting it Right" - impacts positively on the ongoing care and well-being of individuals with dementia. It will evaluate this via a range of accepted objective outcome measures and self-reports by people living with dementia, their family carers and staff supporting them

Ethics approval

14/NW/1117; First MREC approval date 15/08/2014

Study design

Randomised; Interventional and Observational; Design type: Process of Care, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Dementias and neurodegeneration; Subtopic: Dementia; Disease: Dementia

Intervention

1. Booster sessions: Following the one day training event there will be three once monthly booster sessions at the unit to embed the Human Rights Based Approach and ensure compliance with applying the assessment tool.
2. Getting it Right Assessment: The Getting it Right Assessment tool (based on the prinicples of a Human Rights Based Approach and Person Centred care) will be completed by trained staff with people with dementia on their unit.
3. Training package: There is a one day training package based on a Human Rights Based Approach to dementia care which will be delivered to all staff in the intervention arm of the study.

Intervention type

Other

Phase

Drug names

Primary outcome measures

QoL-AD; Timepoint(s): Pre and post intervention

Secondary outcome measures

1. ASCOT measure; Timepoint(s): Pre and post intervention
2. Care plan audit; Timepoint(s): Pre and post intervention
3. CSRI; Timepoint(s): Pre and post intervention
4. Dementia Care Mapping; Timepoint(s): Pre and post intervention
5. EQ5D; Timepoint(s): Pre and post intervention
6. FREDA questionnaire; Timepoint(s): Pre and post intervention
7. Human Rights attitudes questionnaire; Timepoint(s): Pre and post training
8. Human Rights knowledge questionnaire; Timepoint(s): Pre and post training
9. Staff interviews; Timepoint(s): Pre and post intervention
10. WEMWBS; Timepoint(s): Pre and post intervention
11. Zarit Carer Burden Index; Timepoint(s): Pre and post intervention

Overall trial start date

01/03/2015

Overall trial end date

31/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria will be broad:
1. Clusters: All NHS sites involved in the study will be dementia-specific wards. Care homes may be included if caring for people with dementia is part of the facilities core business and they have enough residents with dementia to fulfil the needs of the study.
2. Individuals within clusters: the main inclusion criteria for individuals is a diagnosis of dementia. Issues such as age, severity of dementia, length of time at the setting will be recorded but are not regarded as inclusion/ exclusion criteria in themselves
3. Male & Female
4. At least 18 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 280; UK Sample Size: 280; Description: The above figure for 'total sample size' refers to the estimated number of participants with a diagnosis of dementia,based on 10 clusters with 14 individuals per group in both the intervention and control arms of the trial

Participant exclusion criteria

Individuals who do not have capacity to consent and have no Personal Consultee available to support them in this. There are no other formal Exclusion Criteria, although all participants (people with dementia, carers, staff) will be informed they can withdraw from the study at any stage: requests to withdraw will not be questioned and will be scrupulously honoured.

Recruitment start date

01/03/2015

Recruitment end date

31/08/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Mersey Care NHS Trust
Community Services Dept Mossley Hill Hospital
Liverpool
L18 8BU
United Kingdom

Sponsor information

Organisation

University of Liverpool

Sponsor details

Department of Clinical Psychology
Thompson Yates Building
Quadrangle Brownlow Hill
Liverpool
L69 3GB
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

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