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

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

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.

Study Overview

• Status: Completed
• Conditions: Palliative Care; Advanced Dementia Stages

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • München, Bayern, Germany, 81675
      • Zentrum für kognitive Störungen, Psychiatrische Klinik und Poliklinik, Klinikum Rechts der Isar, TU München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
young onset dementia
late onset dementia

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: German Federal Ministry of Education and Research; Centre Hospitalier Universitaire Vaudois; Ludwig-Maximilians - University of Munich; Deutsche Alzheimer Gesellschaft

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2017
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: palliative care; dementia; young onset dementia; quality of death; late onset dementia
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: PALLVFKS022EPYLOGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No