End of Life CareLiverCareNCT05431946
Palliative Care for Patients With Liver Cirrhosis
An observational study of End of Life Care and Liver Cirrhosis, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial summary
Background: Patients with liver cirrhosis rarely receive palliative care although the Danish Health Authorities and WHO recommend it. The lacking palliative intervention is probably owed to a physician culture focused on life-prolonging active treatment at any cost and unclarities, and misperceptions about palliative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End of Life Care, Liver Cirrhosis, Nurse-Patient Relations
- What is being tested?
- Advance Care Planning and the consequent actions
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2023to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with liver cirrhosis
Who may be able to join
- Liver cirrhosis of any etiology (diagnosed clinically, by imaging or histological features) as predominant chronic illness
- 2 or more items checked on the Supportive and Palliative Care Indicators Tool (SPICT™, appendix)
- Expressed desire for palliative support from the patient and relatives
- Ability to give informed consent
Who cannot join
- Inability to give informed consent
- Age < 18 years
- Ongoing contact with specialized palliative care teams or hospice
- Other chronic life-threatening illness than liver cirrhosis is more likely to become the cause of death within 1-2 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Palliative Care for Patients With Liver Cirrhosis - a Multicentre Intervention Study
Background: Patients with liver cirrhosis rarely receive palliative care although the Danish Health Authorities and WHO recommend it. The lacking palliative intervention is probably owed to a physician culture focused on life-prolonging active treatment at any cost and unclarities, and misperceptions about palliative care, which is perceived by many as exclusively for cancer patients and something that marks the end of active treatment.
Study aim: Measure the effect of palliative care on the patient burden, caregiver burden, and the utilization of healthcare services.
Read more
Study design: Prospective multi-center intervention study with end of study at the patients' death. We will use a 3-faceted endpoint 1) Patient burden measured by change in Hospital Anxiety and Depression Scale, 2) caregiver burden by a change in Zarit Caregiver Burden Questionnaire, and 1) health care system burden as the difference in number, length, and indication for hospital admissions and need for outpatient services.
Patients: We will prospectively include 200 patients with liver cirrhosis (approx. 50 from each of 4-5 sites: Esbjerg, Herlev, Hvidovre, Århus) who have 2 or more items checked on the Supportive and Palliative Care Indicators Tool. Control groups will be identified from two non-participating hospitals and matched regarding age, gender, number of comorbidities, and alcohol and caregiver status.
Methods: The intervention will be advanced care planning with conversations and actions built around a standardized symptom identification tool (EORTC QLQ-C15-PAL). Advance care planning is the collaborative process between patients and health care professionals of planning future health care. The assignment of a contact nurse to each participant is a key part of the intervention.
Results: We will measure patient and caregiver burden at inclusion, after 4-6 weeks, 4-6 months, and every 6 months until the patient dies. All use of health care services will be registered. The use of health care services during the terminal 2 years will be compared that of control patients.
- Being tested
- Advance Care Planning and the consequent actions
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance Care Planning and the consequent actionsBehavioural
Also called Questionnaires
The palliative care intervention is based on the advance care planning process and the actions taken as a consequence of these conversations. The goal is the identification, assessment, and treatment of physical, psychosocial, or spiritual symptoms and problems.
Advance care actions
These are the actions taken to fulfill the advance care plan and can include, but are not limited to:
treatments: pharmacological, psychosocial (priest, psychologist, etc.) referrals: rehabilitation, specialized palliative care team, hospice, etc. communication initiatives with relatives, primary care, public authorities
| Study group | Role | What they receive |
|---|---|---|
| Palliative Care arm | Intervention by Advance care planning (ACP) conversation:The goal is the identification, assessment, and treatment of physical, psychosocial, or spiritual symptoms and problems.
Advance care actions:These are the actions taken to fulfill the advance care plan and can include, but are not limited to:treatments: pharmacological, psychosocial (priest, psychologist, etc.) referrals: rehabilitation, specialized palliative care team, hospice, etc.
communication initiatives with relatives, primary care, public authorities Receives: Behavioral: Advance Care Planning and the consequent actions | |
| Non-participating arm | Will continue standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-subject change in patient burden
Change in Hospital Anxiety and Depression Scale
Measured: From date of inclusion until the date of death from any cause, assessed up to 100 months
Secondary outcomes (2)
Intra-subject change in caregiver burden
Change in Zarit Caregiver Burden Questionnaire
Measured: From date of inclusion until the date of death from any cause, assessed up to 100 months
Inter-group difference in health care system burden
The difference in the use of health care services between intervention and control groups from 2 non-participating hospitals. The difference will be assessed by a review of electronic patient files and sundhed.dk.
Measured: From date of inclusion until the date of death from any cause, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Aug 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End of Life CareStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, Aarhus University Hospital, Hvidovre University Hospital
- Responsible party
- Sponsor
- Investigators
- Mette M Lauridsen, Principal investigator, Head of Liver Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431946
- Sponsor's protocol ID
- LiverCare Denmark
- Acronym
- LiverCare
- Status last verified
- Mar 2025
- First submitted
- 11 May 2022
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
O'Connell MB, Jacobsen BG, Teisner AS, Bager P, Hamberg ML, Mendahl J, Marsaa K, Guldin MB, Kimer N, Lauridsen MM, Ladegaard L. LiverCare - a palliative care intervention for patients with liver cirrhosis: study protocol for a multi-center, pragmatic, non-randomised clinical trial. BMC Palliat Care. 2026 Jun 16. doi: 10.1186/s12904-026-02182-1. Online ahead of print.
PubMed 42304310Gronkjaer LL, Jacobsen BG, Teisner AS, Bager P, Hamberg ML, Mendahl J, Marsaa K, Guldin MB, Kimer N, Lauridsen MM, O Connell MB. The LiverCare intervention: implementing structured palliative care in hepatology - a multicenter mixed-methods feasibility study in patients with cirrhosis. BMC Palliat Care. 2026 Apr 22;25(1):164. doi: 10.1186/s12904-026-02104-1.
PubMed 42021258
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care for Patients With Liver Cirrhosis - a Multicentre Intervention Study
- ClinicalTrials.gov ID
- NCT05431946
- Acronym / sponsor ID
- LiverCare / LiverCare Denmark
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- Herlev Hospital, Aarhus University Hospital, Hvidovre University Hospital
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 24 Jun 2022 (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.
Background: Patients with liver cirrhosis rarely receive palliative care although the Danish Health Authorities and WHO recommend it. The lacking palliative intervention is probably owed to a physician culture focused on life-prolonging active treatment at any cost and unclarities, and misperceptions about palliative care, which is perceived by many as exclusively for cancer patients and something that marks the end of active treatment.
Study aim: Measure the effect of palliative care on the patient burden, caregiver burden, and the utilization of healthcare services.
Study design: Prospective multi-center intervention study with end of study at the patients' death. We will use a 3-faceted endpoint 1) Patient burden measured by change in Hospital Anxiety and Depression Scale, 2) caregiver burden by a change in Zarit Caregiver Burden Questionnaire, and 1) health care system burden as the difference in number, length, and indication for hospital admissions and need for outpatient services.
Patients: We will prospectively include 200 patients with liver cirrhosis (approx. 50 from each of 4-5 sites: Esbjerg, Herlev, Hvidovre, Århus) who have 2 or more items checked on the Supportive and Palliative Care Indicators Tool. Control groups will be identified from two non-participating hospitals and matched regarding age, gender, number of comorbidities, and alcohol and caregiver status.
Methods: The intervention will be advanced care planning with conversations and actions built around a standardized symptom identification tool (EORTC QLQ-C15-PAL). Advance care planning is the collaborative process between patients and health care professionals of planning future health care. The assignment of a contact nurse to each participant is a key part of the intervention.
Results: We will measure patient and caregiver burden at inclusion, after 4-6 weeks, 4-6 months, and every 6 months until the patient dies. All use of health care services will be registered. The use of health care services during the terminal 2 years will be compared that of control patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palliative Care arm | – | Behavioral: Advance Care Planning and the consequent actionsIntervention by Advance care planning (ACP) conversation:The goal is the identification, assessment, and treatment of physical, psychosocial, or spiritual symptoms and problems. Advance care actions:These are the actions taken to fulfill the advance care plan and can include, but are not limited to:treatments: pharmacological, psychosocial (priest, psychologist, etc.) referrals: rehabilitation, specialized palliative care team, hospice, etc. communication initiatives with relatives, primary care, public authorities |
| Non-participating arm | – | –Will continue standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver cirrhosis
Key inclusion criteria (4 listed)
- Liver cirrhosis of any etiology (diagnosed clinically, by imaging or histological features) as predominant chronic illness
- 2 or more items checked on the Supportive and Palliative Care Indicators Tool (SPICT™, appendix)
- Expressed desire for palliative support from the patient and relatives
- Ability to give informed consent
Key exclusion criteria (4 listed)
- Inability to give informed consent
- Age < 18 years
- Ongoing contact with specialized palliative care teams or hospice
- Other chronic life-threatening illness than liver cirrhosis is more likely to become the cause of death within 1-2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advance Care Planning and the consequent actionsAlso: QuestionnairesThe palliative care intervention is based on the advance care planning process and the actions taken as a consequence of these conversations. The goal is the identification, assessment, and treatment of physical, psychosocial, or spiritual symptoms and problems. Advance care actions These are the actions taken to fulfill the advance care plan and can include, but are not limited to: treatments: pharmacological, psychosocial (priest, psychologist, etc.) referrals: rehabilitation, specialized palliative care team, hospice, etc. communication initiatives with relatives, primary care, public authorities | Behavioural | Palliative Care arm |
Primary outcome
Intra-subject change in patient burden
Time frame: From date of inclusion until the date of death from any cause, assessed up to 100 months
Change in Hospital Anxiety and Depression Scale
2 secondary outcomes
Intra-subject change in caregiver burden
Time frame: From date of inclusion until the date of death from any cause, assessed up to 100 months
Inter-group difference in health care system burden
Time frame: From date of inclusion until the date of death from any cause, assessed up to 100 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Derived from this study: PubMed 42304310O'Connell MB, Jacobsen BG, Teisner AS, Bager P, Hamberg ML, Mendahl J, Marsaa K, Guldin MB, Kimer N, Lauridsen MM, Ladegaard L. LiverCare - a palliative care intervention for patients with liver cirrhosis: study protocol for a multi-center, pragmatic, non-randomised clinical trial. BMC Palliat Care. 2026 Jun 16. doi: 10.1186/s12904-026-02182-1. Online ahead of print.
- Derived from this study: PubMed 42021258Gronkjaer LL, Jacobsen BG, Teisner AS, Bager P, Hamberg ML, Mendahl J, Marsaa K, Guldin MB, Kimer N, Lauridsen MM, O Connell MB. The LiverCare intervention: implementing structured palliative care in hepatology - a multicenter mixed-methods feasibility study in patients with cirrhosis. BMC Palliat Care. 2026 Apr 22;25(1):164. doi: 10.1186/s12904-026-02104-1.
- 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.
Mette M Lauridsen principal investigator
Head of Liver Research
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 End of Life Care and Liver Cirrhosis, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 5 Mar 2025. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Intra-subject change in patient burden (time frame: From date of inclusion until the date of death from any cause, assessed up to 100 months). 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 NCT05431946, which also lists 2 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 5 Mar 2025.