Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Martin Blanchard


Contact details

Department of Mental Health Sciences
Royal Free and University College Medical School
Rowland Hill Street
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

How can we best provide palliative care in advanced dementia? Phase II development of an intervention: phase IIa pilot study


Study hypothesis

Our aims are to assess and define the palliative care needs of patients with advanced dementia and their carers and to design and pilot an intervention to improve care.

Our objectives are to:
1. Assess the feasibility of implementing the palliative care needs assessment for patients and advanced care planning for their carers
2. Monitor the consistency of its functional implementation
3. Choose and measure outcomes
4. Examine recruitment rates
5. Assess the feasibility of randomisation
6. Demonstrate acceptable follow-up rates
7. Obtain further views from professionals and patients on the acceptability/practicality of delivering/receiving the intervention

Ethics approval

Ethics approval received from the Camden and Islington Local Research Ethics Committee on the 17th December 2007 (ref: 07/H0722/104).

Study design

A phase IIa pilot study: clustered design with 1 x intervention ward and 1 x control ward

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Advanced neurodegenerative dementia including Alzheimer's disease, Lewy body and vascular or mixed dementia


Intervention group:
A structured nurse-led assessment of patients' physical and mental state with particular attention to pain and other features of advanced dementia such as swallowing and mobility. This is coupled with an educative structured discussion with the carer and, if the carer wishes, the construction of an advanced care plan for the patient.

Control group:
Usual hospital clinical care.

The duration of the intervention is a 1 x 1 hour patient assessment and a 2 x 1 hour care planning discussion with the patients main family carer. Follow up for both arms is six months. Assessment of outcomes will occur at six weeks, then six months. If the subject dies during the study period, their final hospital admission will be audited and their carer interviewed at three months post-bereavement.

Intervention type



Phase II

Drug names

Primary outcome measure

This is a pilot study and a number of potential outcomes will be explored:

Carer related outcomes:
1. Stress and wellbeing-Kessler Distress Scale (KD10)
2. Health status (EQ-5D)
3. Satisfaction with decision-making process:
3.1. Decision Satisfaction Inventory
3.2. Decision Conflicts Scale
4. Satisfaction with care: Satisfaction with End of Life Care in Advanced Dementia Scale
5. Visual Analogue Scale: a standard 10 cm Visual Analogue Scale to measure carer satisfaction with:
5.1. The process of the advanced care planning
5.2. The utility/usefulness of the advance care planning

Patient related outcomes:
1. Active interventions: Painful Interventions Scale
2. Other interventions:
2.1. Resuscitation status
2.2. Percutaneous endoscopic gastrostomy (PEG) feeding
2.3. Prescription of neuroleptics
3. Quality of end of life care:
3.1. Prescription of analgesia at time of death
3.2. Use of Liverpool Care Pathway
4. Survival times: time of intervention to time of death

System related outcomes:
1. Advanced care planning:
1.1. Numbers choosing to make advanced care plan
1.2. Adherence to advance care plan
2. Use of Gold Standards Framework (GSF): by GP (if practice participating in the GSF programme)
3. Referrals to and input from community palliative care
4. Number of contacts after the intervention, i.e., by telephone between carers and the research nurse
5. Readmission rates for emergency acute admissions
6. Place of death
7. Economic outcomes (Client Service Receipt Inventory [CSRI])

Secondary outcome measures

No secondary outcome measures as this is a pilot study, therefore only the establishment of which outcomes are of most utility is being explored.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

We will recruit patients who have a high six-month mortality risk:
1. Unplanned emergency admission to general hospital ward with treatable acute medical illness
2. Over 70 years of age, either sex
3. Diagnosis of advanced primary degenerative dementia:
3.1. Functional assessment staging (FAST) stage 6e or worse
3.2. Doubly incontinent and needing assistance with all activities of daily living

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Imminently dying (prognosis less than 48 hours)
2. Patients without a clearly identified non-statutory carer

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Department of Mental Health Sciences
United Kingdom

Sponsor information


University College London (UK)

Sponsor details

Gower Street
United Kingdom
+44 (0)20 7679 2000

Sponsor type




Funder type


Funder name

BUPA Foundation (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype



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

1. 2008 results in

Publication citations

  1. Results

    Sampson EL, Thuné-Boyle I, Kukkastenvehmas R, Jones L, Tookman A, King M, Blanchard MR, Palliative care in advanced dementia; A mixed methods approach for the development of a complex intervention., BMC Palliat Care, 2008, 7, 8, doi: 10.1186/1472-684X-7-8.

Additional files

Editorial Notes