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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04271085
Ethics application status
Date submitted
27/12/2019
Date registered
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)
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)
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)
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)
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)
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)
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)
Timepoint [5] 0 0
One week
Secondary outcome [6] 0 0
Bereaved relatives' experiences
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2023
Sample size
Target
Accrual to date
Final
1500
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04271085