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 measure
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 (if study stopped)
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
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
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
Basic results (scientific)
Publication list