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

NCT ID: NCT02223780

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective of the study is to assess the effectiveness of the introduction of early specialized palliative care on hospital, intensive care unit and emergency admissions of patients with severe and very severe COPD

Secondary objectives are:

The impact of early palliative care on the mood and anxiety of patients with severe and very severe COPD The impact of early palliative care on the health-related quality of life of patients with severe and very severe COPD.

The impact of early palliative care on the prescription of antibiotics during the last month of life of patients 4. The impact of early palliative care on advance care planning and end-of-life decision-making will be compared between the two groups Methodology Randomized study to one of the two groups in a ratio without stratification.

Study Duration 3 years Study Center(s) Single-center study Number of Subjects 180 patients Intervention Early specialized palliative care intervention Significance Given the trends toward aggressive and costly care near end-of-life among patients with COPD, a timely introduction of palliative care may limit unnecessary and burdensome personal and societal costs, and invasive approaches. The results of this study may provide some direction for future palliative care interventions in this particular population

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

COPD palliative care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control

standard management

Group Type PLACEBO_COMPARATOR

early palliative care

Intervention Type OTHER

the patients will benefit from an early palliative care consultation

early palliative care

early palliative care

Group Type ACTIVE_COMPARATOR

early palliative care

Intervention Type OTHER

the patients will benefit from an early palliative care consultation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

early palliative care

the patients will benefit from an early palliative care consultation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* COPD defined according to GOLD criteria (FEV1/FVC \< 70%) stage III or IV (FEV1 \< 50% predicted)

* and/or long term treatment with either domiciliary oxygen or home mechanical ventilation
* and or one or more hospital admissions in the previous year for an acute exacerbation

Exclusion Criteria

* Moderate or severe cognitive impairment (MMSE\<20)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Swiss National Science Foundation

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jean-Paul Janssens

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Paul Janssens, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Geneva

Geneva, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

Weber C, Stirnemann J, Herrmann FR, Pautex S, Janssens JP. 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. BMC Palliat Care. 2014 Oct 21;13:47. doi: 10.1186/1472-684X-13-47.

Reference Type DERIVED
PMID: 25927907 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.nfp67.ch/

link of the national fund

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

406740_145086/1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Projet 13-102

Identifier Type: -

Identifier Source: org_study_id