Clinical trial NCT03915743: Advance Care Planning Individualised Approach and Research Projec
Official title: The AIR Project - Advance Care Planning Individualised Approach and Research Project. A Single Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Severe COPD
Keywords: Palliative care
Out-patient clinic
COPD symptom burden
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2019-04-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in total Hospital and Anxiety Depression scale (HADS) at 6 months
timeFrame: baseline, 3 and 6 months
Secondary outcomes:
measure: Change from Baseline EORTC QLQ-C15-PAL at 6 months
timeFrame: baseline, 3 and 6 months
measure: Change from Baseline Life-Space Assessment (LSA) at 6 months
timeFrame: baseline, 3 and 6 months
measure: Change from Baseline copd assessment test (CAT) at 6 months
timeFrame: baseline, 3 and 6 months
Other outcomes:
measure: Adherence at 6months
timeFrame: 6 months
measure: Change from Baseline Use of out-patient clinic at 6 months
timeFrame: baseline to 6 months
measure: Change from Baseline in admission frequency at 6 months
timeFrame: baseline to 6 month
Locations:
city: Copenhagen
country: Denmark
facility: Herlev & Gentofte hoospital
state: Herlev/ Reghion H
Study officials:
affiliation: pulmonary department Herlev and Gentofte Hospital
name: Jens-Ulrik Jensen, Phd MD
role: STUDY_DIRECTOR
affiliation: pulmonary department Herlev and Gentofte Hospital
name: Torgny Wilcke Wilcke, phd MD
role: STUDY_DIRECTOR
affiliation: Palliative unite Herlev and Gentofte Hospital
name: Janni Mendahl, APN
role: STUDY_DIRECTOR
affiliation: Pulmonary department Hvidovre Hospital
name: Charlotte Ulrik, Prof. MD DMSc
role: STUDY_DIRECTOR
affiliation: Pulmonary department Hvidovre Hospital
name: Nina Godtfredsen, phd MD
role: STUDY_CHAIR
affiliation: Palliative Unite Herlev and Gentofte Hospital
name: Kristoffer Marså, MD
role: PRINCIPAL_INVESTIGATOR
References: