Terminal CareiLIVENCT04271085
Living Well, Dying Well. a Research Programme to Support Living Until the End
An observational study of Terminal Care, run by Erasmus Medical Center at 11 sites in 11 countries.
Trial summary
The iLIVE project involves a cohort study in which patients with an estimated life expectancy of six months or less are followed until they die. In total, the investigators will include 2200 patients in 11 countries, i.e. 200 per country. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Terminal Care
- What is being tested?
- Observational study
- How many people
- 1,500 participants
- Where
- 11 sitesin 11 countries
- Study dates
- 1 Sep 2020to 31 Jul 2023
- 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: All competent adult patients with an estimated life expectancy of six months or less are eligible, regardless of their diagnosis, gender or age, or place of residence, and their relatives
Who may be able to join
- The patient is aware that recovering from his/her disease is unlikely, to be assessed by the attending physician
- The attending physician would not be surprised if the patient were to die within 6 months
- If the physician is uncertain about the surprise question, the patient is eligible if presenting with at least one SPICT indicator:
- General SPICT indicators:
- Unplanned hospital admission
- Performance status is poor or deteriorating, with limited reversibility (eg stays in bed or in a chair for more than half the day)
Show all 45Show fewer
- Depends on others for care due to increasing physical and/or mental health problems; person's carer needs more help and support
- Progressive weight loss; remains underweight; low muscle mass
- Persistent symptoms despite optimal treatment of underlying condition(s)
- Person (or family) asks for palliative care; chooses to reduce, stop or not have treatment; or wishes to focus on quality of life
- Disease-specific SPICT indicators:
- Cancer:
- Functional ability deteriorating due to progressive cancer
- Too frail for cancer treatment or treatment is for symptom control
- Neurological disease:
- Progressive deterioration in physical and/or cognitive function despite optimal therapy
- Speech problems with increasing difficulty communicating and/or progressive difficulty with swallowing
- Recurrent aspiration pneumonia; breathless or respiratory failure
- Persistent paralysis after stroke with significant loss of function and ongoing disability
- Heart/vascular disease:
- Heart failure or extensive, untreatable coronary artery disease; with breathlessness or chest pain at rest or on minimal effort
- Severe, inoperable peripheral vascular disease
- Respiratory disease:
- Severe, chronic lung disease; with breathlessness at rest or on minimal effort between exacerbations
- Persistent hypoxia needing long term oxygen therapy
- Has needed ventilation for respiratory failure or ventilation is contraindicated
- Kidney disease:
- Stage 4 or 5 chronic kidney disease (eGFR < 30ml/min) with deteriorating health
- Kidney failure complicating other life limiting conditions or treatments
- Stopping or not starting dialysis
- Liver disease:
- Cirrhosis with one or more complications in the past year: diuretic resistant ascites; hepatic encephalopathy; hepatorenal syndrome; bacterial peritonitis; or recurrent variceal bleeds
- Liver transplant is not possible
- Dementia/ frailty:
- Unable to dress, walk or eat without help
- Eating and drinking less, difficulty with swallowing
- Urinary and faecal incontinence
- Not able to communicate by speaking; little social interaction
- Frequent falls; fractured femur
- Recurrent febrile episodes or infections, aspiration pneumonia
- Other conditions:
- o Deteriorating and at risk of dying with other conditions or complications that are not reversible; any treatment available will have a poor outcome
- Family, friend or other close relative of the patient
- 18 years or older
- The relative is aware that it is unlikely that that patient will recover from his/her disease
Who cannot join
- The patient is incapable of filling in a questionnaire in the country's main language or in English (patients may be supported by relatives when filling in the questionnaire)
- The patient is incapable of providing informed consent to participate in the study, to be assessed by the attending physician
- The relative is incapable of filling in a questionnaire in the country's main language or in English
- The relative is incapable of providing informed consent to participate in the study
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
Slovenia1 site
University Clinic for Respiratory and Allergic Diseases Golnik
Ljubljana
About this study
Official title: Living Well, Dying Well. a Research Programme to Support Living Until the End (iLIVE)
The iLIVE project involves a cohort study in which patients with an estimated life expectancy of six months or less are followed until they die. In total, the investigators will include 2200 patients in 11 countries, i.e. 200 per country. The primary outcome for the cohort study is a descriptive assessment of the concerns, expectations and preferences around dying and end-of-life care of patients and their relatives, in different settings and cultures..
Read the detailed description
Rationale: In the EU about 4 million people yearly die from a chronic illness. Many of these people die in pain or distress. Care for dying patients and their close relatives is often suboptimal.
Objective: To contribute to high-quality personalized care at the end of life by:
- Providing in-depth understanding of the concerns, expectations and preferences of patients in the last phase of life and their relatives
- Understanding the cultural, gender, age, healthcare -related and socio-economic variance in these concerns expectations and preferences Study design: The iLIVE project involves a cohort study in which patients with an estimated life expectancy of six months or less are followed until they die. In total, the investigators will include 2200 patients in 11 countries, i.e. 200 per country. Participants are requested to also involve a close relative. Both patients and relatives are asked to fill in a questionnaire, at baseline and after four weeks. If patients die during the study, the relative is asked to fill in a post-bereavement questionnaire. Medical files are studied to assess health care use in the last days of life.
Main study endpoints: The primary outcome for the cohort study is a descriptive assessment of patients' concerns, expectations and preferences around dying and end-of-life care, at baseline and after one month of follow-up.
Potential risks and benefits associated with participation: The study population concerns vulnerable people who may experience fluctuating symptoms and levels of suffering across their disease trajectory. The investigators acknowledge the risk of overburdening or stigmatizing participants. If patients feel burdened by participating in the study, they are encouraged to indicate that. The investigators will develop a protocol for researchers and interviewers to address such situations.
- Conditions
- Terminal Care
- Being tested
- Observational study
- Keywords
- Patients in the last phase of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
No intervention involved
| Study group | Role | What they receive |
|---|---|---|
| Patients in the last phase of life | Patients in the last phase of life and their families Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concerns, expectations and preferences around dying and end-of-life care (descriptive assessment of prevalence)
Self developed questions, adapted from the Serious Illness Conversation Guide and the AEOLI questionnaire.
Measured: Baseline
Concerns, expectations and preferences around dying and end-of-life care (descriptive assessment of prevalence)
Self developed questions, which were inspired by the Serious Illness Conversation Guide and the AEOLI questionnaire.
Measured: One month of follow-up
Secondary outcomes (6)
Edmonton Symptom Assessment Scale (range 0-10, with higher score meaning worse outcome)
Symptoms
Measured: At baseline and after one month of follow-up
European Organisation for Research and Treatment of Cancer Quality of Life C15-Palliative Care questionnaire, quality of life item (range 1-7, with higher score indicating better outcome)
Quality of life
Measured: At baseline and after one month of follow-up
EuroQol-5d questionnaire (range 1-5 per item, with higher score indicating worse outcome)
Quality of life
Measured: At baseline and after one month of follow-up
ICECAP Supportive Care Measure (range 1-4 per item, with higher score indicating worse outcome)
Experience of support
Measured: At baseline and after one month of follow-up
Use of medical interventions (hospitalisation, medication, surgery, other interventions)
Retrospective assessment for patients who die during follow-up of medical interventions in the last week of patients' life, using a self-developed checklist
Measured: One week
Bereaved relatives' experiences
International Care of the dying questionnaire (descriptive), Hogan Grief Reaction Checklist (despair (13 items) and personal growth (12 items) scales, range 1-5 per item)
Measured: 8-10 weeks post-bereavement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Sep 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Terminal CareStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, Klinikum der Universität Köln, Lund University, The University Clinic of Pulmonary and Allergic Diseases Golnik, University of Bern, Cudeca Hospice Foundation, Helse-Bergen HF, Landspitali University Hospital, Pallium Latinoamérica N.G.O, University of Humanistic Studies, Medical University of Vienna, Arohanui Hospice Service Trust
- Responsible party
- Principal investigator, Agnes van der Heide, Erasmus Medical Center
- Investigators
- Agnes van der Heide, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271085
- Sponsor's protocol ID
- H2020-825731
- Acronym
- iLIVE
- Status last verified
- Sep 2023
- First submitted
- 27 Dec 2019
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Well, Dying Well. a Research Programme to Support Living Until the End (iLIVE)
- ClinicalTrials.gov ID
- NCT04271085
- Acronym / sponsor ID
- iLIVE / H2020-825731
- Conditions
- Terminal Care
- Keywords
- Patients in the last phase of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- University of Liverpool, Klinikum der Universität Köln, Lund University, The University Clinic of Pulmonary and Allergic Diseases Golnik, University of Bern, Cudeca Hospice Foundation, Helse-Bergen HF, Landspitali University Hospital, Pallium Latinoamérica N.G.O, University of Humanistic Studies, Medical University of Vienna, Arohanui Hospice Service Trust
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 17 Feb 2020 (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.
The iLIVE project involves a cohort study in which patients with an estimated life expectancy of six months or less are followed until they die. In total, the investigators will include 2200 patients in 11 countries, i.e. 200 per country. The primary outcome for the cohort study is a descriptive assessment of the concerns, expectations and preferences around dying and end-of-life care of patients and their relatives, in different settings and cultures..
Detailed description
Rationale: In the EU about 4 million people yearly die from a chronic illness. Many of these people die in pain or distress. Care for dying patients and their close relatives is often suboptimal.
Objective: To contribute to high-quality personalized care at the end of life by:
- Providing in-depth understanding of the concerns, expectations and preferences of patients in the last phase of life and their relatives
- Understanding the cultural, gender, age, healthcare -related and socio-economic variance in these concerns expectations and preferences Study design: The iLIVE project involves a cohort study in which patients with an estimated life expectancy of six months or less are followed until they die. In total, the investigators will include 2200 patients in 11 countries, i.e. 200 per country. Participants are requested to also involve a close relative. Both patients and relatives are asked to fill in a questionnaire, at baseline and after four weeks. If patients die during the study, the relative is asked to fill in a post-bereavement questionnaire. Medical files are studied to assess health care use in the last days of life.
Main study endpoints: The primary outcome for the cohort study is a descriptive assessment of patients' concerns, expectations and preferences around dying and end-of-life care, at baseline and after one month of follow-up.
Potential risks and benefits associated with participation: The study population concerns vulnerable people who may experience fluctuating symptoms and levels of suffering across their disease trajectory. The investigators acknowledge the risk of overburdening or stigmatizing participants. If patients feel burdened by participating in the study, they are encouraged to indicate that. The investigators will develop a protocol for researchers and interviewers to address such situations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in the last phase of life | – | Other: Observational studyPatients in the last phase of life and their families |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All competent adult patients with an estimated life expectancy of six months or less are eligible, regardless of their diagnosis, gender or age, or place of residence, and their relatives
Key inclusion criteria (45 listed)
- The patient is aware that recovering from his/her disease is unlikely, to be assessed by the attending physician
- The attending physician would not be surprised if the patient were to die within 6 months
- If the physician is uncertain about the surprise question, the patient is eligible if presenting with at least one SPICT indicator:
- Unplanned hospital admission
- Performance status is poor or deteriorating, with limited reversibility (eg stays in bed or in a chair for more than half the day)
Key exclusion criteria (4 listed)
- The patient is incapable of filling in a questionnaire in the country's main language or in English (patients may be supported by relatives when filling in the questionnaire)
- The patient is incapable of providing informed consent to participate in the study, to be assessed by the attending physician
- The relative is incapable of filling in a questionnaire in the country's main language or in English
- The relative is incapable of providing informed consent to participate in the study
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 |
|---|---|---|
| Observational studyNo intervention involved | Other | Patients in the last phase of life |
Primary outcome
Concerns, expectations and preferences around dying and end-of-life care (descriptive assessment of prevalence)
Time frame: Baseline
Self developed questions, adapted from the Serious Illness Conversation Guide and the AEOLI questionnaire.
Concerns, expectations and preferences around dying and end-of-life care (descriptive assessment of prevalence)
Time frame: One month of follow-up
Self developed questions, which were inspired by the Serious Illness Conversation Guide and the AEOLI questionnaire.
6 secondary outcomes
Edmonton Symptom Assessment Scale (range 0-10, with higher score meaning worse outcome)
Time frame: At baseline and after one month of follow-up
European Organisation for Research and Treatment of Cancer Quality of Life C15-Palliative Care questionnaire, quality of life item (range 1-7, with higher score indicating better outcome)
Time frame: At baseline and after one month of follow-up
EuroQol-5d questionnaire (range 1-5 per item, with higher score indicating worse outcome)
Time frame: At baseline and after one month of follow-up
ICECAP Supportive Care Measure (range 1-4 per item, with higher score indicating worse outcome)
Time frame: At baseline and after one month of follow-up
Use of medical interventions (hospitalisation, medication, surgery, other interventions)
Time frame: One week
Bereaved relatives' experiences
Time frame: 8-10 weeks post-bereavement
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 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Terminal Care
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Not yet recruiting
Integrating Rhythmical Massage in Palliative Care
Palliative Care, Health Services, Palliative Care
Active, not recruiting
ACP Video Intervention for Patients With Life-Limiting Illness
Health Care Utilization, End Stage Disease
RecruitingObservational study
Prehospital Care of End-of-Life Patients by the Strasbourg Mobile Emergency and Resuscitation Service: A Qualitative Study of Healthcare Professionals' Experiences and Use of a Comfort Care Booklet
End-of-life Care, Palliative Care
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.
Agnes van der Heide, PhD principal investigator
Erasmus Medical Center
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Terminal Care, run by Erasmus Medical Center at 11 sites in 11 countries.
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 45 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: finished, as of the sponsor's last update on 11 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 11 sites in Argentina, Germany, Iceland, Netherlands, New Zealand and 6 more countries. 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?
Concerns, expectations and preferences around dying and end-of-life care (descriptive assessment of prevalence) (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?
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 11 Mar 2025.