Can a Nurse Specialist improve care for people with memory problems now and in the future?
| ISRCTN | ISRCTN21390601 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21390601 |
| Protocol serial number | 31761 |
| Sponsor | Northumbria Healthcare NHS Foundation Trust |
| Funder | National Institute for Health Research |
- Submission date
- 23/01/2017
- Registration date
- 07/02/2017
- Last edited
- 27/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Currently one in three people aged over 60 years die with dementia. People in the advanced stages of dementia experience similar symptoms to those dying with cancer yet research shows that professional carers have difficulties in providing end of life care to people with dementia (PWD). Symptoms such as pain, agitation or low mood are common but may not be recognised or treated effectively. Most PWD would prefer to die in their usual place of care, but a significant proportion die in hospital. To improve quality of care and help people to die where they wish, it is crucial to explore more effective, integrated models of care. This study is looking at using a Dementia Nurse Specialist, selected resources and a core treatment team to promote change. The Dementia Nurse Specialist will support PWD who are approaching or planning for the end of life and their friend/family carers and to develop capacity and skills among community health and social care staff (e.g. GPs, district nurses and care home staff). The core treatment team will provide comprehensive support to the Dementia Nurse Specialist and facilitate links with existing services. The aim of this study is to look at how the Dementia Nurse Specialist fits into existing services and to collect data to inform a future larger trial.
Who can participate?
People with dementia (PWD) and their carers.
What does the study involve?
Participating GP practices are allocated to one of two groups. Participants attending practices in the first group receive care and support from a Dementia Nurse Specialist. The frequency of the support is tailored to the needs of individual participants. Participants attending practices in the second group receive usual care for the duration for the study. All participants with dementia their carers are followed for up 12 months, using a series of questionnaires administered every four months.
Participants who have taken part are also invited to participate in an additional series of interviews and observations. This involves the interaction of the participant with dementia, and/or family carer, with the dementia nurse specialist and/or healthcare professional being observed by researchers.
What are the possible benefits and risks of participating?
PWD and friend/family carers in intervention sites may benefit from the program. There are often few opportunities for PWD, their friend/family carers and staff providing care to engage in research and to reflect on their thoughts, feelings and opinions. Participation in the project would allow them to explore any issues they feel are relevant with an impartial individual, which may benefit the participants and could be a valuable experience allowing them to discuss issues and decisions that are concerning them with a neutral party and potentially empowering them to seek additional information or support. Bereaved friend/family carers may also welcome the opportunity to speak about their experiences.
While all participants may have limited benefit themselves from participating in the study, their participation may contribute to improving the quality of care received by other PWD, and enhancing the support received by friend/family carers in the future. The number of questionnaires to be completed may be a burden for participants. However, participants will be informed that for their comfort or convenience, they can take a break, postpone or reschedule the visit or complete the questionnaires over a number of sessions. Similar flexibility will be offered in relation to the qualitative interviews conducted for the process evaluation. The voluntary nature of participation will be emphasised. There is also a risk that observation of care may be intrusive for PWD and friend/family carers.
Where is the study run from?
1. Hexham Primary Care Centre (UK)
2. The Bondgate Practice (UK)
3. Saville Medical Group (UK)
4. Collingwood surgery (UK)
When is the study starting and how long is it expected to run for?
April 2016 to September 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Professor Louise Robinson
a.l.robinson@ncl.ac.uk
Contact information
Scientific
Newcastle University Institute for Ageing and Institute for Health & Society
Newcastle University
Newcastle Biomedical Research Building
Campus for Ageing and Vitality
Newcastle upon Tyne
NE4 5PL
United Kingdom
| Phone | +44 191 208 7013 |
|---|---|
| a.l.robinson@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised; Both; Design type: Process of Care, Management of Care, Qualitative |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | SEED Workstream 4: A feasibility study of the supporting excellence in end of life care in dementia intervention |
| Study acronym | SEED WS4 |
| Study objectives | The aim of this study is to explore how an evidence-based intervention comprising a Dementia Nurse Specialist selected resources and a core intervention team to promote change fits into existing services and to collect data to inform a future definitive trial. |
| Ethics approval(s) | North East - Newcastle & North Tyneside 1 Research Ethics Committee, 16/01/2017, ref: 16/NE/0356 |
| Health condition(s) or problem(s) studied | Specialty: Primary Care, Primary sub-specialty: Dementias and neurodegeneration (DeNDRoN); UKCRC code/ Disease: Neurological/ Other degenerative diseases of the nervous system |
| Intervention | Pilot Trial: GP practices are allocated to one of two groups, at ratio of 1:1. Intervention Group : The intervention is care and support from a Dementia Nurse Specialist. Participants with dementia, and family carer participants, will receive the intervention. The frequency of the intervention will be tailored to the needs of individual participants. Control Group : Participants with dementia, and family carer participants, will receive usual care for the duration for the study. All participants with dementia, and family carer participants, will be followed for up 12 months, using a series of questionnaires administered every 4 months. In both arms, where the person with dementia, or the family member, are unable to complete questionnaires, key informants and/or healthcare professionals will be invited to give consent to complete questionnaires on their behalf. Process Evaluation: Participants who have consented to take part in the pilot trial will also be invited to participate in an additional series of interviews and observations. This involves the interaction of the participant with dementia, and/or family carer, with the dementia nurse specialist and/or healthcare professional being observed by researchers. The researchers may take notes or audio record the interactions. Healthcare professionals as participants may also be observed during their interactions with the dementia nurse specialist. Researchers may take notes or audio record these interactions. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Recruitment rate is measured using the number of eligible participants who consent to participate in the study by 12 months |
| Key secondary outcome measure(s) |
1. Health status is measured using EQ-5D-5L questionnaire at baseline, 4, 8 and 12 months, and 2 months after the death of the person with dementia |
| Completion date | 30/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 129 |
| Key inclusion criteria | Inclusion Criteria for the Pilot Trial: People With Dementia 1. People on the dementia register who received a diagnosis of dementia in the last two years 2. People who are on both the dementia and palliative care registers 3. People on the dementia register who are considered to be within 12 months of end of life as judged by a member of the clinical care team Carers 1. Main family member of the above participant with dementia 2. Age 18 years or over Key informants Key informants of participating people with dementia will be health or social care participant with dementia and able to report on quality of life, behavioural and psychological symptoms of dementia, symptom management, etc. Inclusion criteria for process evaluation 1. Participants with dementia who have consented to participate in the pilot trial and agreed to contact by the qualitative research team 2. Family members of participants with dementia recruited to the study who have consented to participate in the pilot trial and agreed to contact by the qualitative research team 3. Health and social care professionals linked to intervention sites who provide end of life care to participants with dementia and their families 4. Members of the core intervention team 5. Members of the primary care team most closely involved in screening and study recruitment in control sites. |
| Key exclusion criteria | Patients with Dementia: 1. Under the age of 18 years 2. Judged as inappropriate for the study by a member of the primary care team (e.g. due to concurrent life events such as bereavement) 3. Not fluent English speakers 4. Not consenting to be contacted by the qualitative team during the initial trial consent process (process evaluation only) 5. Lack of capacity to consent (process evaluation) Carers: Not consenting to be contacted by the qualitative team during the initial trial consent process (process evaluation only). Exclusion criteria for process evaluation 1. Participants with dementia and/or family members who do not consent to contact by the qualitative team during the initial pilot trial consent process 2. Potential participants who refuse consent 3. Any individuals under the age of 18 years |
| Date of first enrolment | 01/03/2017 |
| Date of final enrolment | 30/06/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Corbridge Road
Hexham
NE46 1QJ
United Kingdom
Alnwick
NE66 2NL
United Kingdom
Newcastle upon Tyne
NE1 8DQ
United Kingdom
North Shields
NE29 0SF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets analysed during the current study will be available upon request from Professor Louise Robinson a.l.robinson@newcastle.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2020 | 27/11/2020 | Yes | No |
| HRA research summary | 26/07/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/11/2020: Publication reference added.
