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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03915743
Other study ID # AIR
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01285180 - Quality of Life in Daxas-treated Patients Older Than 18 Years With Severe COPD N/A
Completed NCT04023409 - The Identification of Phenotypes in Patients With Severe Chronic Obstructive Pulmonary Disease (Groningen Severe COPD Cohort)