Severe COPD
Conditions
Keywords
Palliative care, Out-patient clinic, COPD symptom burden
Brief summary
The study will investigate the effect of a palliative approach in the out-patient management of patients with COPD.
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.
Interventions
OTHERpalliative care
complex and multi-faceted individualized palliative care
Sponsors
Herlev and Gentofte Hospital
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
RCT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in total Hospital and Anxiety Depression scale (HADS) at 6 months | baseline, 3 and 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline EORTC QLQ-C15-PAL at 6 months | baseline, 3 and 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 |
| Change from Baseline Life-Space Assessment (LSA) at 6 months | baseline, 3 and 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 |
| Change from Baseline copd assessment test (CAT) at 6 months | baseline, 3 and 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Use of out-patient clinic at 6 months | baseline to 6 months | number of out-patient clinic visits |
| Change from Baseline in admission frequency at 6 months | baseline to 6 month | numbers of admissions in the study periode |
| Adherence at 6months | 6 months | measured by inhaled medicine bought at the pharmacy. Data is gather from a national database |
Countries
Denmark
Outcome results
None listed