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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04271085




Registration number
NCT04271085
Ethics application status
Date submitted
27/12/2019
Date registered
17/02/2020
Date last updated
17/02/2020

Titles & IDs
Public title
Living Well, Dying Well. A Research Programme to Support Living Until the End
Scientific title
Living Well, Dying Well. A Research Programme to Support Living Until the End (iLIVE)
Secondary ID [1] 0 0
H2020-825731
Universal Trial Number (UTN)
Trial acronym
iLIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Terminal Care 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Observational study

Patients in the last phase of life - Patients in the last phase of life and their families


Other interventions: Observational study
No intervention involved

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
One month of follow-up
Secondary outcome [1] 0 0
Edmonton Symptom Assessment Scale (range 0-10, with higher score meaning worse outcome) - Symptoms
Timepoint [1] 0 0
At baseline and after one month of follow-up
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
At baseline and after one month of follow-up
Secondary outcome [3] 0 0
EuroQol-5d questionnaire (range 1-5 per item, with higher score indicating worse outcome) - Quality of life
Timepoint [3] 0 0
At baseline and after one month of follow-up
Secondary outcome [4] 0 0
ICECAP Supportive Care Measure (range 1-4 per item, with higher score indicating worse outcome) - Experience of support
Timepoint [4] 0 0
At baseline and after one month of follow-up
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
One week
Secondary outcome [6] 0 0
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)
Timepoint [6] 0 0
8-10 weeks post-bereavement

Eligibility
Key inclusion criteria
Inclusion Criteria patients:

- 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)

- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria patients:

- 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

Inclusion Criteria relatives:

- 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

Exclusion Criteria relatives:

- 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Germany
State/province [2] 0 0
Cologne
Country [3] 0 0
Iceland
State/province [3] 0 0
Reykjavík
Country [4] 0 0
Netherlands
State/province [4] 0 0
Rotterdam
Country [5] 0 0
New Zealand
State/province [5] 0 0
Palmerston North
Country [6] 0 0
Norway
State/province [6] 0 0
Bergen
Country [7] 0 0
Slovenia
State/province [7] 0 0
Ljubljana
Country [8] 0 0
Spain
State/province [8] 0 0
Málaga
Country [9] 0 0
Sweden
State/province [9] 0 0
Lund
Country [10] 0 0
Switzerland
State/province [10] 0 0
Bern
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Other
Name
Erasmus Medical Center
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Liverpool
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Klinikum der Universität Köln
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Lund University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The University Clinic of Pulmonary and Allergic Diseases Golnik
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Bern
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Cudeca Hospice Foundation
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Helse-Bergen HF
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Landspitali University Hospital
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Pallium Latinoamérica N.G.O
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
University of Humanistic Studies
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
Medical University of Vienna
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Other
Name [12] 0 0
Arohanui Hospice Service Trust
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Other
Name [13] 0 0
St Vincent's Hospital Melbourne
Address [13] 0 0
Country [13] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. 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..
Trial website
https://clinicaltrials.gov/show/NCT04271085
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Agnes van der Heide, PhD
Address 0 0
Erasmus Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Agnes van der Heide, PhD
Address 0 0
Country 0 0
Phone 0 0
+310107043719
Fax 0 0
Email 0 0
a.vanderheide@erasmusmc.nl
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04271085