To contribute to high-quality personalized care at the end of life by:a. Providing in-depth understanding of the concerns, expectations and preferences of patients in the last phase of life and their relativesb. Understanding the cultural, gender,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
patienten met een levensverwachting van 6 maanden of minder, ongeacht de aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primaire outcome: frequencies of concerns, expectations and preferences of
patients in the last phase of life after inclusion and after one month
Secondary outcome
Secondary endpoints are:
- Symptoms (ESAS, at baseline and after one month);
- Health-related quality of life (EORTC QLQ-C15-PAL quality of life item and
EQ-5D-5L, at baseline and after one month);
- ICECAP-SCM scores;
- Use of medical interventions and medicines and costs of medical care in the
last week of life (medical file data);
- Bereaved relatives* experiences and their appreciation of care and support in
the last days of life of the decedent, and bereavement levels (bereavement
questionnaire);
- Patient survival.
Background summary
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.
Study objective
To contribute to high-quality personalized care at the end of life by:
a. Providing in-depth understanding of the concerns, expectations and
preferences of patients in the last phase of life and their relatives
b. 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, we
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 and physician are asked to fill in a
post-bereavement questionnaire. Medical files are studied to assess health care
use in the last days of life.
Study burden and risks
The study population concerns vulnerable people who may experience fluctuating
symptoms and levels of suffering across their disease trajectory. We
acknowledge the risk of overburdening or stigmatizing participants. If patients
feel burdened by participating in the study, they are encouraged to indicate
that.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Patient
1. Patient is 18 years or older.
2. The patient is aware that recovering from his/her disease is unlikely, to be
assessed by the attending physician.
3. The attending physician would not be surprised if the patient were to die
within 6 months.
4. If the physician is uncertain about the surprise question, the patient is
eligible if presenting with at least one SPICT indicator
Relative
Relatives of participating patients are eligible to participate in the study if
they are 18 years or older and provide informed consent to participate, and if
the patient agrees. Relatives can be a family member, friend or other close
relative. They have to be aware that the patient is unlikely to recover from
his/her disease.
Exclusion criteria
Patient
1.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).
2. The patient is incapable of providing informed consent to participate in the
study, as assessed by the attending physician.
Relative
Relatives are not eligible if they are incapable of filling in a questionnaire
in the country*s main language or in English.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04271085 |
| CCMO | NL72756.100.20 |