Clinical trial NCT03364179: IssuEs in Palliative Care for People in Advanced and Terminal Stages of Young-onset and Late-Onset Dementia in GErmany
Official title: IssuEs in Palliative Care for People in Advanced and Terminal Stages of Young-onset and Late-Onset Dementia in GErmany (EPYLOGE-Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Dementia Stages
Palliative Care
Keywords: dementia
young onset dementia
quality of death
late onset dementia
palliative care
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
name: Deutsche Alzheimer Gesellschaft
name: Centre Hospitalier Universitaire Vaudois
name: German Federal Ministry of Education and Research
First posted: 2017-12-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients suffering from young onset and late onset dementia in advanced and terminal stages who live in LTC facilities or at home and their family caregivers

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: patient´s quality of life in late stage dementia
timeFrame: Baseline
measure: patient´s comfort of dying with dementia
timeFrame: Assessment B at the latest 4 months after patient's death
Secondary outcomes:
measure: symptoms and symptom management in late-stage dementia and during the dying process
timeFrame: 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)
measure: palliative care provision in late-stage dementia and during the dying process
timeFrame: Assessment A (inclusion, patient is alive) and Assessment B (as soon as possible after patient´s death, at the latest 4 months after death)
measure: health care utilization in late-stage dementia and during the dying process
timeFrame: Assessment A (inclusion, patient is alive) and Assessment B (as soon as possible after patient´s death, at the latest 4 months after death)
measure: Caregivers' problems, challenges, barriers, needs, preferences in late-stage dementia and during the dying process
timeFrame: Assessment A (inclusion, patient is alive) and Assessment B (as soon as possible after patient´s death, at the latest 4 months after death)
measure: family caregivers' burden and coping
timeFrame: Assessment A (inclusion, patient is alive) and Assessment B (as soon as possible after patient´s death, at the latest 4 months after death)
measure: family caregivers´satisfaction with care
timeFrame: Assessment A (inclusion, patient is alive) and Assessment B (as soon as possible after patient´s death, at the latest 4 months after death)
Other outcomes:
Locations:
city: München
country: Germany
facility: Zentrum für kognitive Störungen, Psychiatrische Klinik und Poliklinik, Klinikum Rechts der Isar, TU München
state: Bayern
Study officials:
References:
citation: Diehl-Schmid J, Hartmann J, Rossmeier C, Riedl L, Forstl H, Egert-Schwender S, Kehl V, Schneider-Schelte H, Jox RJ. IssuEs in Palliative care for people in advanced and terminal stages of Young-onset and Late-Onset dementia in GErmany (EPYLOGE): the study protocol. BMC Psychiatry. 2018 Aug 31;18(1):271. doi: 10.1186/s12888-018-1846-0.
citation: Riedl L, Kiesel E, Hartmann J, Fischer J, Rossmeier C, Haller B, Kehl V, Priller J, Trojan M, Diehl-Schmid J. A bitter pill to swallow - Polypharmacy and psychotropic treatment in people with advanced dementia. BMC Geriatr. 2022 Mar 16;22(1):214. doi: 10.1186/s12877-022-02914-x.