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Status:

COMPLETED

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

Lead Sponsor:

Erasmus Medical Center

Collaborating Sponsors:

University of Liverpool

Klinikum der Universität Köln

Conditions:

Terminal Care

Eligibility:

All Genders

18+ years

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 ...

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. Obj...

Eligibility Criteria

Inclusion

  • 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
  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2020

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    July 31 2023

    Estimated Enrollment :

    1500 Patients enrolled

    Trial Details

    Trial ID

    NCT04271085

    Start Date

    September 1 2020

    End Date

    July 31 2023

    Last Update

    March 11 2025

    Active Locations (11)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    1

    Pallium Latinoamérica

    Buenos Aires, Argentina

    2

    University Hospital Cologne

    Cologne, Germany

    3

    Landspitali National University Hospital of Iceland

    Reykjavik, Iceland

    4

    Agnes van der Heide

    Rotterdam, Netherlands, 3000 CA