Advance Care Planning Individualised Approach and Research Projec

NCT ID: NCT03915743

Last Updated: 2021-02-12

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

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-11-01

Brief Summary

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The study will investigate the effect of a palliative approach in the out-patient management of patients with COPD.

Detailed Description

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Randomised control trial. A total of 90 patients will be randomise 1:1 to either palliative intervention or standard care.

The intervention group will receive follow up in a newly established outpatient clinic for COPD in the specialized palliative united and the control group will receive standard follow up in the respiratory out-patient clinic.

Conditions

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Severe COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Palliative care

Specialized palliative care arm in a newly formed COPD outpatient clinic

Group Type EXPERIMENTAL

palliative care

Intervention Type OTHER

complex and multi-faceted individualized palliative care

Usual care

Usual care in a standard pulmonary out-patient clinic. Treatment as described in national standards.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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palliative care

complex and multi-faceted individualized palliative care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* • Diagnosis of COPD by spirometry

* Patients followed in Herlev and Gentofte hospitals' respiratory out-patient-clinics or admitted to Herlev or Gentofte hospital for acute exacerbation
* 2 or more admissions for acute exacerbation of COPD within the last 12 months
* CAT \> 20
* Cognitive and linguistic able to understand and give informed consent

Exclusion Criteria

* • Expected remaining life time less than 6 months due to other disease than COPD e.g. active cancer

* Participating in other studies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kristoffer Marsaa

Head of section, senior consultant MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens-Ulrik Jensen, Phd MD

Role: STUDY_DIRECTOR

pulmonary department Herlev and Gentofte Hospital

Torgny Wilcke Wilcke, phd MD

Role: STUDY_DIRECTOR

pulmonary department Herlev and Gentofte Hospital

Janni Mendahl, APN

Role: STUDY_DIRECTOR

Palliative unite Herlev and Gentofte Hospital

Charlotte Ulrik, Prof. MD DMSc

Role: STUDY_DIRECTOR

Pulmonary department Hvidovre Hospital

Nina Godtfredsen, phd MD

Role: STUDY_CHAIR

Pulmonary department Hvidovre Hospital

Kristoffer Marså, MD

Role: PRINCIPAL_INVESTIGATOR

Palliative Unite Herlev and Gentofte Hospital

Locations

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Herlev & Gentofte hoospital

Copenhagen, Herlev/ Reghion H, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AIR

Identifier Type: -

Identifier Source: org_study_id

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