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

Study Overview
=================
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.

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.

Official Title
-----------------
Rethink Pulmonary Rehabilitation (REPORT Study)

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Other: No Intervention, just observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Decliners of Pulmonary Rehabilitation<br>No intervention, just observation | Other: No Intervention, just observation<br>* No Intervention, just observation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD Assessment Test (CAT) | Observation of changes in points. Lower score indicates improvement | baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-Minute Walk Test Distance (6MWD) | Observation of changes i meters. High is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) | 
| Hospital Anxiety and Depression Scale (HADS) | Observation of changes in point. Low score is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) | 
| Euro-Qol (EQ5D) | Observation of changes in Visual analogue scale (VAS). Higher VAS is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) | 
| Brief Pain Inventory (BPI) | Observation of changes in points. Low is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) | 
| Multidimensional Fatigue Inventory (MFI-20) | Observation of changes in points. Low is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassesment) | 
| Short Physical Performance Battery (SPPB) | Observation of changes in point. High is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) | 
| Hand-Grip Strength (JAMAR) | Observation of changes in kilo. High is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) | 
| 30 seconds sit-to-stand test (30sec-STS) | Observation of changes in repetitions. High is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) | 
| Pittsburgh Sleep Quality Index (PSQI) | Observation of changes in point. Low score is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) | 
| Number of hospital admissions (respiratory and all-cause) | Observation of changes in actual numbers. Low is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) | 
| Length of hospital admissions (respiratory and all-cause) | Observation of changes in days. Low is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) | 
| Out-patient visits | Observation of changes in actual number. Low is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) | 
| Mortality (respiratory and all-cause) | Observation of changes as number of deaths. Low is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassesment) | 
| Timed Up and Go Test | Observation of changes in seconds. Low is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) | 
| Activity level (ActivPAL) | Observation of changes in steps per day. High is better | baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) - Worn by the patients around the clock for 5 days |