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

COPD Clinical Trial

— REPORT  

Official title:

Rethink Pulmonary Rehabilitation (REPORT Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249388
• Other study ID #: 19072886
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• No Intervention, just observation
No Intervention, just observation

Locations

Country	Name	City	State
Denmark	Bispebjerg and Frederiksberg University Hospital	Copenhagen	Copenhagen North West
Denmark	Gentofte and Herlev University Hospital	Gentofte	Hellerup
Denmark	Nordsjaelland University Hospital	Hillerød
Denmark	Amager and Hvidovre University Hospital	Hvidovre	Danmark

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg	Herlev and Gentofte Hospital, Hillerod Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD Assessment Test (CAT)	Observation of changes in points. Lower score indicates improvement	baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Secondary	6-Minute Walk Test Distance (6MWD)	Observation of changes i meters. High is better	baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Secondary	Hospital Anxiety and Depression Scale (HADS)	Observation of changes in point. Low score is better	baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Secondary	Euro-Qol (EQ5D)	Observation of changes in Visual analogue scale (VAS). Higher VAS is better	baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Secondary	Brief Pain Inventory (BPI)	Observation of changes in points. Low is better	baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Secondary	Multidimensional Fatigue Inventory (MFI-20)	Observation of changes in points. Low is better	baseline and 52 weeks reassessment, (potentially 104 weeks reassesment)
Secondary	Short Physical Performance Battery (SPPB)	Observation of changes in point. High is better	baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Secondary	Hand-Grip Strength (JAMAR)	Observation of changes in kilo. High is better	baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Secondary	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)
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Observation of changes in point. Low score is better	baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Secondary	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)
Secondary	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)
Secondary	Out-patient visits	Observation of changes in actual number. Low is better	baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Secondary	Mortality (respiratory and all-cause)	Observation of changes as number of deaths. Low is better	baseline and 52 weeks reassessment, (potentially 104 weeks reassesment)
Secondary	Timed Up and Go Test	Observation of changes in seconds. Low is better	baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Secondary	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