Human rights in dementia care
| ISRCTN | ISRCTN94553028 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94553028 |
| Secondary identifying numbers | 18379 |
- 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
Scientific
Mersey Care NHS Trust
Community Services Dept
Mossley Hill Hospital
Liverpool
L18 8BU
United Kingdom
Study information
| Study design | Randomised; Interventional and Observational; Design type: Process of Care, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient 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 | 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 study start date | 01/03/2015 |
| Completion date | 31/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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 |
| 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
- England
- United Kingdom
Study participating centre
Mersey Care NHS Trust
Community Services Dept
Mossley Hill Hospital
Liverpool
L18 8BU
United Kingdom
Mossley Hill Hospital
Liverpool
L18 8BU
United Kingdom
Sponsor information
University of Liverpool
Hospital/treatment centre
Hospital/treatment centre
Department of Clinical Psychology
Thompson Yates Building
Quadrangle Brownlow Hill
Liverpool
L69 3GB
England
United Kingdom
"ROR" |
https://ror.org/04xs57h96 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
