Advance Care Planning Individualised Approach and Research Projec (AIR)

The AIR Project - Advance Care Planning Individualised Approach and Research Project. A Single Center Randomized Controlled Trial

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

Study Overview

• Status: Terminated
• Conditions: Severe COPD
• Intervention / Treatment: Other: palliative care

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev/ Reghion H
    • Copenhagen, Herlev/ Reghion H, Denmark, 2730
      • Herlev & Gentofte hoospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Palliative care; Specialized palliative care arm in a newly formed COPD outpatient clinic	Other: palliative care; complex and multi-faceted individualized palliative care
No Intervention: Usual care; Usual care in a standard pulmonary out-patient clinic. Treatment as described in national standards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in total Hospital and Anxiety Depression scale (HADS) at 6 months	questionnaire measuring anxiety and Depression in 2 subscales in this study we use the total value of the 2 subscales combined. The higher the number the worse the psychological impact. HADS total was a range from 0 to 24 where 0 is no psychological distress	baseline, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline EORTC QLQ-C15-PAL at 6 months	questionnaire, consists of 14 questions and a license audit goal from 1 to 7 where 7 is the best possible quality of life.For the first 14 questions about symptoms, the scale goes from 1 to 4 where 4 is the worst	baseline, 3 and 6 months
Change from Baseline Life-Space Assessment (LSA) at 6 months	questionnaire,5 questions about where the patient has been in the last 4 weeks. Question 1 is other than bedroom and question 5 is out of his home town. In addition, questions are asked about how frequently and on the use of aids.finally the scales are converted to numerical value between 0 and 120 where 0 is worst and expresses that the patient is constant in bed	baseline, 3 and 6 months
Change from Baseline copd assessment test (CAT) at 6 months	questionnaire. 8 items questionnaire where there should be between 0 and 5 where 5 is the worst. Together, this gives a total scale between 0 and 40 where 40 is worst	baseline, 3 and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence at 6months	measured by inhaled medicine bought at the pharmacy. Data is gather from a national database	6 months
Change from Baseline Use of out-patient clinic at 6 months	number of out-patient clinic visits	baseline to 6 months
Change from Baseline in admission frequency at 6 months	numbers of admissions in the study periode	baseline to 6 month

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Collaborators: Hvidovre University Hospital
• Investigators: Study Director: Jens-Ulrik Jensen, Phd MD, pulmonary department Herlev and Gentofte Hospital; Study Director: Torgny Wilcke Wilcke, phd MD, pulmonary department Herlev and Gentofte Hospital; Study Director: Janni Mendahl, APN, Palliative Unite Herlev and Gentofte Hospital; Study Director: Charlotte Ulrik, Prof. MD DMSc, Pulmonary department Hvidovre Hospital; Study Chair: Nina Godtfredsen, phd MD, Pulmonary department Hvidovre Hospital; Principal Investigator: Kristoffer Marså, MD, Palliative Unite Herlev and Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: January 27, 2019
• First Submitted That Met QC Criteria: April 14, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Palliative care; Out-patient clinic; COPD symptom burden
• Other Study ID Numbers: AIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No