The effectiveness of Collaborative Care feasibility study
| ISRCTN | ISRCTN74015152 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74015152 |
| Secondary identifying numbers | 12134; HTA 08/53/99 |
- Submission date
- 24/05/2012
- Registration date
- 24/05/2012
- Last edited
- 12/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Dementia is one of the main causes of disability in later life, causing more disability than stroke, arthritis and other joint diseases, heart disease and cancer. In the UK, there are currently around 700,000 people with dementia but this is estimated to rise to 1 million by 2020 and 1.7 million by 2050, an increase of over 150%. The standard of dementia care in the UK is very variable. The fragmentation of services for people with dementia and their families has been acknowledged by the National Dementia Strategy (NDS). The NDS proposes dementia care advisers, who will give information to people with dementia and their carers, and act as signposts to services and support. Our proposal is to test one interpretation of the proposed advisers’ role. Research from the USA has revealed the potential of a 'collaborative care' approach. Collaborative care means professionals from different backgrounds (general practitioners, specialists in old age psychiatry, community mental health nurse) support a 'case manager' who works closely with the patient and their family. This close working relationship is based on a management plan of support, brief psychological therapy and where appropriate medication that is tailored to each person with dementia and their family or other carers. The plan will include well-thought out ways of managing communication issues; behaviour problems (agitation, aggression); mobility; personal care; sleep; legal and financial issues; physical health; depression and anxiety; psychotic symptoms; and carer support. The management plan includes regular, planned follow-ups and the case manger keeps all the relevant professionals informed about progress. We do not think that this case manager needs to be a new kind of professional. On the contrary, case management methods can be learned and applied by professionals already working in the community. District and practice nurses are already working with people with dementia, and could apply case management methods systematically if trained to do so. General practitioners with a special interest in dementia could also take on the case manager role. Our study proposes to test these ideas, and measure their effect on people with dementia and their carers.
Who can participate?
People with dementia who live independently in the community
What does the study involve?
In the first part of the study we adapt the US case management methods to the circumstances of the NHS, and develop a training programme that could be used throughout the health service if the method proves effective. The second part of the study is a 'dress rehearsal' for a large scale study. The dress rehearsal is carried out in a small number of practices, to test that the training works, and that its effects can be measured. If there are problems with the training package, or difficulties in recruiting practice, they can be identified and rectified at this stage.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Newcastle University (UK)
When is the study starting and how long is it expected to run for?
June 2012 to December 2012
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Dr Vanessa Hogan
v.e.hogan@ncl.ac.uk
Contact information
Scientific
Newcastle University
William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
| v.e.hogan@ncl.ac.uk |
Study information
| Study design | Non-randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effectiveness of Collaborative Care for people with dementia in primary care |
| Study objectives | The study will consist of a pilot rehearsal trial plus engagement of primary care trusts, Practice based commissioning localities and consortia, individual practices and other relevant agencies and services. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/085399 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0011/52967/PRO-08-53-99.pdf |
| Ethics approval(s) | NRES West London and South East Coast Surrey Research Ethics Committees, 28/09/2011, ref: 11/LO/1555 |
| Health condition(s) or problem(s) studied | Dementias and Neurodegenerative Diseases |
| Intervention | Pilot study, Our intervention is to pilot the previously developed Collaborative Care Intervention in primary care. |
| Intervention type | Other |
| Primary outcome measure | NPI questionnaire measured at 6 months post intervention. |
| Secondary outcome measures | MMSE, BADLS, Qol-AD and DEMQOL questionnaires measured at baseline and 6 months post intervention |
| Overall study start date | 01/06/2012 |
| Completion date | 01/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 44; UK Sample Size: 44; Description: 44 patients in total. 11 patients per GP practice. |
| Key inclusion criteria | 1. People with a diagnosis of any type of dementia, confirmed by secondary care assessment. 2. Living independently in the community at the time of baseline assessment and with a spouse, close relative or other informal carer who maintains regular contact and who can be approached as a potential participant and informant 3. Target Gender: Male & Female |
| Key exclusion criteria | 1. People with a diagnosis of dementia who are living in institutional care 2. People with a diagnosis of dementia deemed in need of pallative care (less than 12 months to live, as assessed by the patient's GP) |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 01/12/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NE2 4HH
United Kingdom
Sponsor information
University/education
Department of Primary Care and Population Sciences
Hampstead Campus
Rowland Hill Street
London
NW3 2PF
England
United Kingdom
| Phone | +44 (0)20 7679 2000 |
|---|---|
| abc@email.com | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- 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 | 01/08/2014 | Yes | No |
Editorial Notes
12/05/2016: Plain English summary added.
