Advanced Dementia StagesEPYLOGENCT03364179
IssuEs in Palliative Care for People in Advanced and Terminal Stages of Young-onset and Late-Onset Dementia in GErmany
An observational study of Advanced Dementia Stages and Palliative Care, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Dementia Stages, Palliative Care
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 19 Aug 2017to 30 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- at least one inclusion criterion is not met
Trial locations and contacts
1 site in 1 country.
Germany1 site
Zentrum für kognitive Störungen, Psychiatrische Klinik und Poliklinik, Klinikum Rechts der Isar, TU München
München, Bavaria, 81675
About this study
Official title: 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.
- Conditions
- Advanced Dementia Stages, Palliative Care
- Keywords
- dementia, young onset dementia, quality of death, late onset dementia, palliative care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| young onset dementia | Not described | |
| late onset dementia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Assessment B at the latest 4 months after patient's death
Secondary outcomes (6)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Assessment A (inclusion, patient is alive) and Assessment B (as soon as possible after patient´s death, at the latest 4 months after death)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start19 Aug 2017
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced Dementia StagesStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, Deutsche Alzheimer Gesellschaft, Centre Hospitalier Universitaire Vaudois, German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Janine Diehl-Schmid, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364179
- Sponsor's protocol ID
- PALLVFKS022EPYLOGE
- Acronym
- EPYLOGE
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2017
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30170575Diehl-Schmid J, Rossmeier C, Slawik T, Hartmann J, Riedl L, Kehl V. Home Care of People With Advanced Late-Onset and Young-Onset Dementia Living in Germany. Alzheimer Dis Assoc Disord. 2025 Oct-Dec 01;39(4):263-268. doi: 10.1097/WAD.0000000000000687. Epub 2025 Nov 14.
PubMed 41233710Riedl 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.
PubMed 35296254
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IssuEs in Palliative Care for People in Advanced and Terminal Stages of Young-onset and Late-Onset Dementia in GErmany (EPYLOGE-Study)
- ClinicalTrials.gov ID
- NCT03364179
- Acronym / sponsor ID
- EPYLOGE / PALLVFKS022EPYLOGE
- Conditions
- Advanced Dementia Stages, Palliative Care
- Keywords
- dementia, young onset dementia, quality of death, late onset dementia, palliative care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, Deutsche Alzheimer Gesellschaft, Centre Hospitalier Universitaire Vaudois, German Federal Ministry of Education and Research
- Study start
- 19 Aug 2017 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| young onset dementia | – | – |
| late onset dementia | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- at least one inclusion criterion is not met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
patient´s quality of life in late stage dementia
Time frame: Baseline
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
patient´s comfort of dying with dementia
Time frame: Assessment B at the latest 4 months after patient's death
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.
6 secondary outcomes
symptoms and symptom management in late-stage dementia and during the dying process
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Assessment A (inclusion, patient is alive) and Assessment B (as soon as possible after patient´s death, at the latest 4 months after death)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Background: PubMed 30170575Diehl-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.
- Derived from this study: PubMed 41233710Diehl-Schmid J, Rossmeier C, Slawik T, Hartmann J, Riedl L, Kehl V. Home Care of People With Advanced Late-Onset and Young-Onset Dementia Living in Germany. Alzheimer Dis Assoc Disord. 2025 Oct-Dec 01;39(4):263-268. doi: 10.1097/WAD.0000000000000687. Epub 2025 Nov 14.
- Derived from this study: PubMed 35296254Riedl 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.
- EPYLOGE. Eine Studie zur Palliativversorgung bei Demenz in DeutschlandLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Dementia Stages and Palliative Care, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient´s quality of life in late stage dementia (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03364179, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.