Advance Care Planning Individualised Approach and Research Projec

Severe COPD Clinical Trial

— AIR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03915743
• Other study ID #: AIR
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: February 2021
• Source: Herlev and Gentofte Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Severe COPD

Intervention

Other:
• palliative care
complex and multi-faceted individualized palliative care

Locations

Country	Name	City	State
Denmark	Herlev & Gentofte hoospital	Copenhagen	Herlev/ Reghion H

Sponsors (2)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital	Respiratory section, Hvidovre Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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