Clinical Trials Directory

Trials / Completed

CompletedNCT04249388

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

Rethink Pulmonary Rehabilitation (REPORT Study)

Status
Completed
Phase
Study type
Observational
Enrollment
102 (actual)
Sponsor
University Hospital Bispebjerg and Frederiksberg · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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.

Detailed description

Objective This cohort study aims to describe and understand differences and similarities in characteristics among people with severe and advanced COPD who opt-in or opt out of PR services. The study includes data from: socio-demographic, anthropometric, physical (function, activity, muscle strength, balance) characteristics as well as self-reported symptoms of anxiety, depression, fatigue, pain, lung symptoms, quality of life, sleep-quality, mortality, hospitaladmissions, length of stay and qualitative patient interviews. Data from our completed trial study (NCT02667171) will be used as the opt-in PR comparison cohort.

Conditions

Interventions

TypeNameDescription
OTHERNo Intervention, just observationNo Intervention, just observation

Timeline

Start date
2020-02-01
Primary completion
2022-12-31
Completion
2022-12-31
First posted
2020-01-30
Last updated
2023-05-10

Locations

4 sites across 1 country: Denmark

Source: ClinicalTrials.gov record NCT04249388. Inclusion in this directory is not an endorsement.