Living Well, Dying Well. a Research Programme to Support Living Until the End

NCT04271085 | Completed DMC

• 1 other identifier: H2020-825731
• Study Type: observational
• Target: 1,500
• Locations: 11 countries
• Sites: 11

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..

Conditions

Terminal Care

Keywords

Patients in the last phase of life

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  One month of follow-up

Secondary Outcomes (6)

• Edmonton Symptom Assessment Scale (range 0-10, with higher score meaning worse outcome)

  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)

  At baseline and after one month of follow-up

• EuroQol-5d questionnaire (range 1-5 per item, with higher score indicating worse outcome)

  At baseline and after one month of follow-up

• ICECAP Supportive Care Measure (range 1-4 per item, with higher score indicating worse outcome)

  At baseline and after one month of follow-up

• Use of medical interventions (hospitalisation, medication, surgery, other interventions)

  One week

Study Arms (1)

Patients in the last phase of life

Patients in the last phase of life and their families

Other: Observational study

Interventions

Observational study OTHER

No intervention involved

Patients in the last phase of life

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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:

You may not qualify if:

• 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
• Family, friend or other close relative of the patient
• years or older
• The relative is aware that it is unlikely that that patient will recover from his/her disease
• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• University of Liverpool: collaborator
• Klinikum der Universität Köln: collaborator
• Lund University: collaborator
• The University Clinic of Pulmonary and Allergic Diseases Golnik: collaborator
• University of Bern: collaborator
• Cudeca Hospice Foundation: collaborator
• Helse-Bergen HF: collaborator
• Landspitali University Hospital: collaborator
• Pallium Latinoamérica N.G.O: collaborator
• University of Humanistic Studies: collaborator
• Medical University of Vienna: collaborator
• Arohanui Hospice Service Trust: collaborator

Study Sites (11)

Pallium Latinoamérica

Buenos Aires, Argentina

Location

University Hospital Cologne

Cologne, Germany

Location

Landspitali National University Hospital of Iceland

Reykjavik, Iceland

Location

Agnes van der Heide

Rotterdam, 3000 CA, Netherlands

Location

Arohanui Hospice Service

Palmerston North, New Zealand

Location

Haukeland University Hospital

Bergen, Norway

Location

University Clinic for Respiratory and Allergic Diseases Golnik

Ljubljana, Slovenia

Location

Centro de Cuidados Paliativos Cudeca

Málaga, Spain

Location

Skåne University Hospital

Lund, Sweden

Location

Bern University Hospital

Bern, Switzerland

Location

University of Liverpool

Liverpool, United Kingdom

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Agnes van der Heide, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: February 17, 2020
• Study Start: September 1, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: March 11, 2025

Record last verified: 2023-09

Locations

IC (1); NO (1); NZ (1); CH (1); AR (1); DE (1); GB (1); SL (1); SE (1); NL (1); ES (1)