Human rights in dementia care

ISRCTN	ISRCTN94553028
DOI	https://doi.org/10.1186/ISRCTN94553028
Protocol serial number	18379
Sponsor	University of Liverpool
Funder	National Institute for Health Research

Submission date: 18/03/2015
Registration date: 20/03/2015
Last edited: 17/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sarah Butchard
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised; Interventional and Observational; Design type: Process of Care, Qualitative
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Embedding a human rights based approach to dementia care
Study objectives	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(s)	14/NW/1117; First MREC approval date 15/08/2014
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	QoL-AD; Timepoint(s): Pre and post intervention
Key secondary outcome measure(s)	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
Completion date	31/08/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	280
Total final enrolment	439
Key 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
Key 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.
Date of first enrolment	01/03/2015
Date of final enrolment	31/08/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Mersey Care NHS Trust

Community Services Dept
Mossley Hill Hospital
Liverpool
L18 8BU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2018	17/12/2020	Yes	No
HRA research summary			26/07/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
14/09/2017: No publications found, verifying study status with principal investigator.