IssuEs in Palliative Care for People in Advanced and Terminal Stages of Young-onset and Late-Onset Dementia in GErmany

Study Overview
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Brief Summary
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From a scientific view, palliative care issues in dementia are neglected in Germany. Neither in Germany nor internationally research has been conducted on palliative care issues in young onset dementia (YOD), although significant differences compared to late onset dementia (LOD) are expected. Most international studies have focused on patients in long term care (LTC) facilities but have neglected patients that are cared for at home. We hypothesize that in advanced and terminal stages of YOD and LOD unmet care needs exist and that they differ between YOD and LOD. By prospectively assessing and surveying 200 patients with YOD and LOD in advanced stages who are cared for in LTC facilities and at home and investigating circumstances of death of 100 YOD- and LOD-patients, it is possible 1) to describe symptoms and management, health care utilization, palliative care provision, quality of life and death, elements of advance care planning, family caregivers' needs and satisfaction; 2) to compare YOD and LOD; 3) to develop expert-consensus recommendations derived from study results for the improvement and implementation of strategies and interventions for palliative care provision. 4) to communicate the recommendations nationally and internationally in order to improve and adapt guidelines, to implement the recommendations into daily practice and to give a basis and perspectives for future research projects; to communicate the results to patients and their families in order to counsel and support them in their decision making processes and their dialogue with professional caregivers and physicians.

Official Title
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IssuEs in Palliative Care for People in Advanced and Terminal Stages of Young-onset and Late-Onset Dementia in GErmany (EPYLOGE-Study)

Conditions
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Advanced Dementia Stages, Palliative Care

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with moderate or severe dementia (CDR = 2 or 3) Patient lives at home or in long term care Patient has got a family caregiver > 18 years Family caregiver has sufficient knowledge of German language Written informed consent of family caregiver Written informed consent of patient or legal representative, respectively Documents of legal representative/ Power of attorney Exclusion criteria • at least one inclusion criterion is not met

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| young onset dementia<br> | |
| late onset dementia<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient´s quality of life in late stage dementia | Quality of ife in late-stage dementia scale (QUALID-Scale): 11 questions, Score 1 to 5 each, total sum score range 11 to 55, 11 means highest quality of life | Baseline | 
| patient´s comfort of dying with dementia | Comfort assessment of dying with dementia (CAD-EOLD)-Scale: Subscale of End of Life in Dementia Scale (EOLD), 14 symptoms/ conditions during patient´s dying process to be rated by proxy, Score 1-3 each. Total sum score range 14 to 42. 42 means highest level of comfort during dying process. | Assessment B at the latest 4 months after patient's death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms and symptom management in late-stage dementia and during the dying process | adapted version of End of Life in Dementia -Symptom Management scale (SM-EOLD); patient´s examination; assessment of drug treatment and non-medical therapies by evaluation of medical files | Assessment A (study inclusion, patient is alive) and Assessment B (as soon as possible after patient´s death, at the latest 4 months after death) | 
| palliative care provision in late-stage dementia and during the dying process | semi-structured interviews with the caregiver to assess the status quo of (palliative) care issues (e.g. availability of general outpatient palliative care (AAPV), specialized outpatient palliative care (SAPV) or palliative care nurses; description of LTC setting; caregivers´experiences with palliative care) | Assessment A (inclusion, patient is alive) and Assessment B (as soon as possible after patient´s death, at the latest 4 months after death) | 
| health care utilization in late-stage dementia and during the dying process | semi-structured interviews with the caregivers | Assessment A (inclusion, patient is alive) and Assessment B (as soon as possible after patient´s death, at the latest 4 months after death) | 
| Caregivers' problems, challenges, barriers, needs, preferences in late-stage dementia and during the dying process | open questions to the family caregiver | Assessment A (inclusion, patient is alive) and Assessment B (as soon as possible after patient´s death, at the latest 4 months after death) | 
| family caregivers' burden and coping | various scales, e.g. the adapted version of Caregiver Strain Index (CSI) | Assessment A (inclusion, patient is alive) and Assessment B (as soon as possible after patient´s death, at the latest 4 months after death) | 
| family caregivers´satisfaction with care | various scales, e.g. the adapted version of End of life in dementia-Satisfaction with Care, (SWC-EOLD) | Assessment A (inclusion, patient is alive) and Assessment B (as soon as possible after patient´s death, at the latest 4 months after death) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dementia, young onset dementia, quality of death, late onset dementia, palliative care