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12 May 2008
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| [ Print-friendly version ] |
| A pilot study of a palliative care intervention for people with advanced dementia |
| ISRCTN | ISRCTN03330837 |
| ClinicalTrials.gov identifier | |
| Public title | A pilot study of a palliative care intervention for people with advanced dementia |
| Scientific title | How can we best provide palliative care in advanced dementia? Phase II development of an intervention: phase IIa pilot study |
| Acronym | N/A |
| Serial number at source | N/A |
| 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.
Objectives: 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Advanced neurodegenerative dementia including Alzheimer's disease, Lewy body and vascular or mixed dementia |
| Participants - 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 |
| Participants - exclusion criteria |
1. Imminently dying (prognosis less than 48 hours)
2. Patients without a clearly identified non-statutory carer |
| Anticipated start date | 02/02/2008 |
| Anticipated end date | 02/08/2008 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 40 |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) | No secondary outcome measures as this is a pilot study, therefore only the establishment of which outcomes are of most utility is being explored. |
| Sources of funding | BUPA Foundation (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Martin Blanchard |
| Address |
Department of Mental Health Sciences
Royal Free and University College Medical School Rowland Hill Street |
| City/town | London |
| Zip/Postcode | NW3 2PF |
| Country | United Kingdom |
| m.blanchrad@medsch.ucl.ac.uk | |
| Sponsor | University College London (UK) |
| Address | Gower Street |
| City/town | London |
| Zip/Postcode | WC1E 6BT |
| Country | United Kingdom |
| Tel | +44 (0)20 7679 2000 |
| e.sampson@medsch.ucl.ac.uk | |
| Sponsor website: | http://www.ucl.ac.uk |
| Date applied | 30/01/2008 |
| Last edited | 25/03/2008 |
| Date ISRCTN assigned | 25/03/2008 |
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