NCT02223780|CompletedDMC

Early Palliative Care for Patients With Severe and Very Severe COPD: a Randomised Study

Can Early Introduction of Specialized Palliative Care Limit Intensive Care, Emergency and Hospital Admissions in Patients With Severe and Very Severe COPD? A Randomized Study

University Hospital, Geneva ClinicalTrials.gov

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2 other identifiers

Projet 13-102406740_145086/1

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredAug 2014

StartedSep 2013

CompletionJul 2017

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a common and, despite existing treatment options, progressive lung disease. Patients with COPD often have only limited access to palliative care. The goal of this research project is to improve the quality of life of patients with COPD. Background In many cases, the symptoms of advanced COPD (including shortness of breath, pain and depression) are insufficiently alleviated. In addition, often in connection with an infection, patients frequently suffer from respiratory decompensation; this may lead to invasive interventions as well as the admission to the emergency room or an intensive care unit. It may ultimately lead to the death of the patient. Aim This study aims to show that early palliative care can reduce the number of necessary invasive interventions and improve the quality of life of patients with COPD. For this purpose, a group of patients receiving early, standardized palliative care will be compared to a group of patients receiving customary treatment only, without systematic intervention by palliative care experts. Significance The results of this study should make it possible to efficiently use the medical resources which are required for the appropriate care of patients with COPD. The goal is the best possible quality of life and better coordination of the measures taken, especially with regard to the area of acute care and the wishes of the patient.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.8 years study duration

Study Start

First participant enrolled

September 1, 2013

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed

14 days until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed

Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

3.8 years

First QC Date

August 8, 2014

Last Update Submit

October 31, 2021

Conditions

COPD

Keywords

COPDpalliative care

Outcome Measures

Primary Outcomes (1)

length of stay hospital, intensive care unit and emergency admissions
number of days
1 year

Secondary Outcomes (2)

depression and anxiety
1 year
Health related quality of life assessed by a generic questionnaire
1 year

Study Arms (2)

control

PLACEBO COMPARATOR

standard management

Other: early palliative care