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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Vanessa Hogan
Scientific

Newcastle University
William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Email v.e.hogan@ncl.ac.uk

Study information

Study designNon-randomised interventional trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)GP practice
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effectiveness of Collaborative Care for people with dementia in primary care
Study objectivesThe 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) studiedDementias and Neurodegenerative Diseases
InterventionPilot study, Our intervention is to pilot the previously developed Collaborative Care Intervention in primary care.
Intervention typeOther
Primary outcome measureNPI questionnaire measured at 6 months post intervention.
Secondary outcome measuresMMSE, BADLS, Qol-AD and DEMQOL questionnaires measured at baseline and 6 months post intervention
Overall study start date01/06/2012
Completion date01/12/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 44; UK Sample Size: 44; Description: 44 patients in total. 11 patients per GP practice.
Key inclusion criteria1. 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 criteria1. 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 enrolment01/06/2012
Date of final enrolment01/12/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Newcastle University
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

University College London (UK)
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
Email abc@email.com
Website http://www.ucl.ac.uk/
ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Government

Health Technology Assessment Programme
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.