Clinical trial NCT04249388: Characteristics of People With Advanced Chronic Obstructive Pulmonary Disease (COPD) - A Multicenter Study
Official title: Rethink Pulmonary Rehabilitation (REPORT Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Hillerod Hospital, Denmark
name: Herlev and Gentofte Hospital
First posted: 2020-01-30
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: COPD Assessment Test (CAT)
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Secondary outcomes:
measure: 6-Minute Walk Test Distance (6MWD)
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
measure: Euro-Qol (EQ5D)
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
measure: Brief Pain Inventory (BPI)
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
measure: Multidimensional Fatigue Inventory (MFI-20)
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassesment)
measure: Short Physical Performance Battery (SPPB)
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
measure: Hand-Grip Strength (JAMAR)
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
measure: 30 seconds sit-to-stand test (30sec-STS)
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
measure: Number of hospital admissions (respiratory and all-cause)
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
measure: Length of hospital admissions (respiratory and all-cause)
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
measure: Out-patient visits
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
measure: Mortality (respiratory and all-cause)
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassesment)
measure: Timed Up and Go Test
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
measure: Activity level (ActivPAL)
timeFrame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) - Worn by the patients around the clock for 5 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg and Frederiksberg University Hospital
state: Copenhagen North West
city: Hvidovre
country: Denmark
facility: Amager and Hvidovre University Hospital
state: Danmark
city: Gentofte
country: Denmark
facility: Gentofte and Herlev University Hospital
state: Hellerup
city: Hillerød
country: Denmark
facility: Nordsjaelland University Hospital
Study officials:
affiliation: Hvidovre University Hospital, Respiratory Department and Research Unit
name: Charlotte Suppli Ulrik, MD, DMSc
role: STUDY_CHAIR
References: