Advance Care Planning Individualised Approach and Research Projec

Study Overview
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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.

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

Conditions
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Severe COPD

Intervention / Treatment
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* Other: palliative care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative care, Out-patient clinic, COPD symptom burden