NCT04459143

Brief Summary

The aim of this study is to evaluate if the participation of COPD patients to a workshop on advance directives increases the number of patients who write them.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
525

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

September 19, 2024

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

July 1, 2020

Last Update Submit

September 3, 2024

Conditions

Keywords

COPDPalliative careAdvance directivesExacerbationDyspnea

Outcome Measures

Primary Outcomes (1)

  • Number of patient who write their advance directives

    The Primary Outcome Measure is the collect of the number of patients who write their advance directives after their participation of the health workshop

    At the end of patient hospital stay, approximately 6 weeks

Secondary Outcomes (1)

  • Measure of patient's satisfaction

    At the end of patient hospital stay, approximately 6 weeks

Interventions

A workshop will take place during the third week of patient care to inform them about COPD, exacerbations, prognostic and advance directives. Then, a personal interview with patients who have participated to this workshop will take place at the end of their hospital stay, to collect their advance directives and their degree of satisfaction about this process.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with COPD Gold 3 or 4 who accept to participate to the workshop

You may qualify if:

  • COPD Gold 3 or 4 and Curtis criteria

You may not qualify if:

  • left to the discretion of the investigator if he finds that it will not be beneficial for the patient : for example if the workshop is judged to be at risk of being anxiety-provoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Cèdres SSR Pneumologie / Réhabilitation Respiratoire

Aincourt, 95510, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Interventions

Advance Directives

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

JurisprudenceSocial Control, FormalHealth Care Economics and OrganizationsAdvance Care PlanningPatient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Jean-François Boitiaux

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 7, 2020

Study Start

May 16, 2019

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

September 19, 2024

Record last verified: 2021-02

Locations