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

Rethink Pulmonary Rehabilitation (REPORT Study)

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: No Intervention, just observation

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.

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Nordsjaelland University Hospital
  • Copenhagen North West
    • Copenhagen, Copenhagen North West, Denmark, 2400
      • Bispebjerg and Frederiksberg University Hospital
  • Danmark
    • Hvidovre, Danmark, Denmark, 2650
      • Amager and Hvidovre University Hospital
  • Hellerup
    • Gentofte, Hellerup, Denmark, 2900
      • Gentofte and Herlev University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Decliners of Pulmonary Rehabilitation; No intervention, just observation	Other: No Intervention, just observation; No Intervention, just observation

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

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Collaborators: Hillerod Hospital, Denmark; Herlev and Gentofte Hospital
• Investigators: Study Chair: Charlotte Suppli Ulrik, MD, DMSc, Hvidovre University Hospital, Respiratory Department and Research Unit

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 19072886

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Proposal for data use should be addressed to Henrik.hansen.09@regionh.dk

Data access in Denmark are under very strict juristic data protection law.

Any possible access or sharing demands a part application to

1. Danish Data Protection Agency,
2. Ethics Committee of the Capital Region
3. National Health Data Authorities.

Only if the applications are approved data will be considered available for sharing. The authors will not be able to support this process and a prolonged process must be expected.

• IPD Sharing Time Frame: unresolved
• IPD Sharing Access Criteria: Please read plan description
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No