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COVID-19
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| Name | Class |
|---|---|
| Hvidovre University Hospital | OTHER |
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The study will investigate the effect of a palliative approach in the out-patient management of patients with COPD.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palliative care | Experimental | Specialized palliative care arm in a newly formed COPD outpatient clinic |
|
| Usual care | No Intervention | Usual care in a standard pulmonary out-patient clinic. Treatment as described in national standards. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| palliative care | Other | complex and multi-faceted individualized palliative care |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
• Diagnosis of COPD by spirometry
Exclusion Criteria:
• Expected remaining life time less than 6 months due to other disease than COPD e.g. active cancer
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Nina Godtfredsen, phd MD | Pulmonary department Hvidovre Hospital | Study Chair |
| Kristoffer Marså, MD | Palliative Unite Herlev and Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev & Gentofte hoospital | Copenhagen | Herlev/ Reghion H | 2730 | Denmark |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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RCT
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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 |
| baseline to 6 months |
| Change from Baseline in admission frequency at 6 months | numbers of admissions in the study periode | baseline to 6 month |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |