Characteristics of People With Advanced Chronic Obstructive Pulmonary Disease (COPD) - A Multicenter Study

NCT04249388 | Completed DMC

• 1 other identifier: 19072886
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 4

Brief Summary

Pulmonary rehabilitation (PR) is a cornerstone of care for people with COPD. There is robust evidence that PR improves exercise capacity, enhances health-related quality of life (QoL) and reduces healthcare utilization. PR is strongly recommended in guidelines for COPD management. Despite the compelling evidence for its benefits, PR is delivered to less than 30% of people with COPD. Access is particularly challenging, an especially for those with the most progressed disease stages. We recently completed a randomized clinical trial, showing that approximately 1.100 patients annually are offered conventional hospital-based PR during routine consultations in the Capital Region of Denmark, but at least 700 patients declines participation. No major cohort studies have been published from people with severe and advanced COPD who opt out of traditional pulmonary rehabilitation. By establishing such cohort study, objective and qualitative knowledge from assessments and patient interviews is collected in patients we have very limited access to and knowledge of. Additionally, the collected data will give a deeper insight and understanding and possibly enable us to design new delivery models to be tested in proper study designs.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• COPD Assessment Test (CAT)

  Observation of changes in points. Lower score indicates improvement

  baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

Secondary Outcomes (15)

• 6-Minute Walk Test Distance (6MWD)

  baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

• Hospital Anxiety and Depression Scale (HADS)

  baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

• Euro-Qol (EQ5D)

  baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

• Brief Pain Inventory (BPI)

  baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)

• Multidimensional Fatigue Inventory (MFI-20)

  baseline and 52 weeks reassessment, (potentially 104 weeks reassesment)

Study Arms (1)

Decliners of Pulmonary Rehabilitation

No intervention, just observation

Other: No Intervention, just observation

Interventions

No Intervention, just observation OTHER

No Intervention, just observation

Decliners of Pulmonary Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective observational study of patients with COPD who declines participation in a conventional out-patient hospital-based PR program.

You may qualify if:

• Clinical diagnosis of COPD defined as a ratio of forced expiratory volume at one second (FEV1) to forced vital capacity \< 0.70
• FEV1 \<50%, corresponding to severe or very severe COPD
• Symptoms equivalent to the Medical Research Council (MRC) from 2 to 5
• Declines to participate in a conventional out-patient hospital-based PR program

You may not qualify if:

• Concurrent participation in or recent completion of pulmonary rehabilitation within the last twelve months.
• Dementia/ Cognitive impairment or uncontrolled psychiatric illness,
• An impaired hearing and / or vision which causes the instructions in the assessment is not understood.
• language difficulties which causes inability to follow instruction or complete patient reported outcome measures (PROM.)
• Any comorbidity that are contraindicated to the assesment protocol.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Hillerod Hospital, Denmark: collaborator
• Herlev and Gentofte Hospital: collaborator

Study Sites (4)

Bispebjerg and Frederiksberg University Hospital

Copenhagen, Copenhagen North West, 2400, Denmark

Location

Amager and Hvidovre University Hospital

Hvidovre, Danmark, 2650, Denmark

Location

Gentofte and Herlev University Hospital

Gentofte Municipality, Hellerup, 2900, Denmark

Location

Nordsjaelland University Hospital

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Charlotte Suppli Ulrik, MD, DMSc

  Hvidovre University Hospital, Respiratory Department and Research Unit

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: February 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: unresolved
• Access Criteria: Please read plan description

Locations

DK (4)