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Compassion Pilot Intervention Study to Enhanced Integrated Care for People With Severe Memory Problems

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ClinicalTrials.gov Identifier: NCT02840318
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : August 16, 2016
Marie Curie Hospice, Belfast
Information provided by (Responsible Party):
University College, London

Brief Summary:
The investigators developed the theory-driven 'Compassion Intervention', an integrated, interdisciplinary approach to address existing gaps in end-of-life care for people with advanced dementia. The Intervention consists of two core components: facilitation of an integrated, multi-disciplinary approach to assessment, treatment and care; and education, training and support for formal and informal carers. The intervention is implemented by an Interdisciplinary Care Leader. The primary aim is to understand how the Intervention operates in two care homes (with nursing support) in two different health and social care economies; one in the Camden Commissioning Group and one in the Barnet Commissioning Group, both in London, UK. The secondary aim is to collect preliminary outcome data and estimate the cost of employing an Interdisciplinary Care Leader to inform further evaluative studies. The final aim is to check that the Intervention causes no harm to residents and their family carers.

Condition or disease Intervention/treatment Phase
Dementia Other: Compassion Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Compassion Intervention: A Pilot Study of Enhanced Integrated Care for People With Severe Memory Problems
Study Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia Memory

Arm Intervention/treatment
Experimental: Compassion Intervention
Coordinated by the ICL who co-ordinates key activities at each site to address the two core components of the Intervention. Component 1 activities include: (a) person-centred assessment of residents, focussing on their physical, psychological, emotional and social needs, (b) meetings of the core care team (General practitioner, care home nurse and/or manager and ICL) and (c) meetings of the wider multidisciplinary care teams (including care home staff, ICL, and external healthcare professionals such as geriatrician, palliative care, mental health etc). Activities to facilitate component 2 include: (d) staff training sessions, education and support for staff and family carers. Training sessions are run by the ICL and logistics of training is planned at core meetings.
Other: Compassion Intervention
See arm description

Primary Outcome Measures :
  1. Pain Assessment in Advanced Dementia [ Time Frame: up to 6 months ]
    Warden, 2003

Secondary Outcome Measures :
  1. Waterlow Scale [ Time Frame: up to 6 months ]
    pressure ulcer risk (Waterlow, 1985)

  2. Neuropsychiatric Inventory [ Time Frame: up to 6 months ]
    (Cummings, 1994)

  3. Cohen Mansfield Agitation Inventory [ Time Frame: Monthly up to 6 months ]
    (Cohen Mansfield, 1989)

  4. Symptom Management at End of Life in Dementia [ Time Frame: up to 6 months ]
    (Kiely, 2006)

  5. Quality of Life in Late Stage Dementia Scale [ Time Frame: up to 6 months ]
    (Weiner, 2000)

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • residents residing in one of the two participating care homes;
  • memory problems indicating a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV);
  • Functional Assessment Staging scale (FAST) grade 6a (difficulty putting on clothing) and above (unable to hold head up) (Reisberg, 1988);
  • Comorbidities or unmanaged symptoms such as agitation, recurrent infections, pain and pressure ulcers.

Exclusion Criteria:

  • Residents who indicate either verbally or non-verbally that they do not wish to participate.
  • Residents who are moribund, in a coma, or those where there are clinical concerns that may preclude them being approached.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840318

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United Kingdom
University College, London
London, Select One..., United Kingdom, W1T 7NF
Sponsors and Collaborators
University College, London
Marie Curie Hospice, Belfast
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Principal Investigator: Caroline (Louise) Jones, MB FRCP University College, London
Fitch K, Bernstein S, Aguilar M, Burnand B, LaCalle J, Lázaro P, et al. The RAND/UCLA Appropriateness Method User's Manual Santa Monica: RAND, 2001.
Wimo A, Winblad B. Resource Utilization in Dementia: RUD Lite. Brain Aging. 2003;3:48-59.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02840318    
Other Study ID Numbers: 14/007
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: February 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University College, London:
Terminal care
Residential facilities
Integrated health care systems
Interdisciplinary health team
Palliative care
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders