Advance Care Planning Individualised Approach and Research Projec

NCT03915743 | Terminated

• 1 other identifier: AIR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Severe COPD

Keywords

Palliative care; Out-patient clinic; COPD symptom burden

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from Baseline EORTC QLQ-C15-PAL at 6 months

  baseline, 3 and 6 months

• Change from Baseline Life-Space Assessment (LSA) at 6 months

  baseline, 3 and 6 months

• Change from Baseline copd assessment test (CAT) at 6 months

  baseline, 3 and 6 months

Other Outcomes (3)

• Adherence at 6months

  6 months

• Change from Baseline Use of out-patient clinic at 6 months

  baseline to 6 months

• Change from Baseline in admission frequency at 6 months

  baseline to 6 month

Study Arms (2)

Palliative care

EXPERIMENTAL

Specialized palliative care arm in a newly formed COPD outpatient clinic

Other: palliative care

Usual care

NO INTERVENTION

Usual care in a standard pulmonary out-patient clinic. Treatment as described in national standards.

Interventions

palliative care OTHER

complex and multi-faceted individualized palliative care

Palliative care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• Hvidovre University Hospital: collaborator

Study Sites (1)

Herlev & Gentofte hoospital

Copenhagen, Herlev/ Reghion H, 2730, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of section, senior consultant MD

Model Details: RCT

Study Record Dates

• First Submitted: January 27, 2019
• First Posted: April 16, 2019
• Study Start: May 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)