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

Completed

• Conditions: Terminal Care
• Interventions: Other: Observational study

• Registration Number: NCT04271085
• Lead Sponsor: Erasmus Medical Center

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..

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:

1. Providing in-depth understanding of the concerns, expectations and preferences of patients in the last phase of life and their relatives

2. 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 Timeline

• Study First Submitted: 2019-12-27
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-17
• Study Start: 2020-09-01
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2023-09
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients in the last phase of life	Observational study	Patients in the last phase of life and their families

Primary Outcome Measures

Name	Time	Method
Concerns, expectations and preferences around dying and end-of-life care (descriptive assessment of prevalence)	One month of follow-up	Self developed questions, which were inspired by the Serious Illness Conversation Guide and the AEOLI questionnaire.

Secondary Outcome Measures

Name	Time	Method
Use of medical interventions (hospitalisation, medication, surgery, other interventions)	One week	Retrospective assessment for patients who die during follow-up of medical interventions in the last week of patients' life, using a self-developed checklist
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	Quality of life
EuroQol-5d questionnaire (range 1-5 per item, with higher score indicating worse outcome)	At baseline and after one month of follow-up	Quality of life
ICECAP Supportive Care Measure (range 1-4 per item, with higher score indicating worse outcome)	At baseline and after one month of follow-up	Experience of support
Edmonton Symptom Assessment Scale (range 0-10, with higher score meaning worse outcome)	At baseline and after one month of follow-up	Symptoms
Bereaved relatives' experiences	8-10 weeks post-bereavement	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)

Trial Locations

Locations (11)

Landspitali National University Hospital of Iceland; 🇮🇸 Reykjavík, Iceland

Haukeland University Hospital; 🇳🇴 Bergen, Norway

University Clinic for Respiratory and Allergic Diseases Golnik; 🇸🇮 Ljubljana, Slovenia

Bern University Hospital; 🇨🇭 Bern, Switzerland

Centro de Cuidados Paliativos Cudeca; 🇪🇸 Málaga, Spain

Pallium Latinoamérica; 🇦🇷 Buenos Aires, Argentina

University Hospital Cologne; 🇩🇪 Cologne, Germany

Arohanui Hospice Service; 🇳🇿 Palmerston North, New Zealand

Agnes van der Heide; 🇳🇱 Rotterdam, Netherlands

Skåne University Hospital; 🇸🇪 Lund, Sweden

University of Liverpool; 🇬🇧 Liverpool, United Kingdom