Advance Care Planning Individualised Approach and Research Projec

Not Applicable

Terminated

• Conditions: Severe COPD
• Interventions: Other: palliative care

• Registration Number: NCT03915743
• Lead Sponsor: Herlev and Gentofte Hospital

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.

Study Timeline

• Study First Submitted: 2019-01-27
• Study First Submitted QC: 2019-04-14
• Study First Posted: 2019-04-16
• Study Start: 2019-05-01
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

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Exclusion Criteria

• • Expected remaining life time less than 6 months due to other disease than COPD e.g. active cancer

  • Participating in other studies

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Palliative care	palliative care	Specialized palliative care arm in a newly formed COPD outpatient clinic

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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

Trial Locations

Locations (1)

Herlev & Gentofte hoospital; 🇩🇰 Copenhagen, Herlev/ Reghion H, Denmark