Clinical trial NCT02667171: COPD Online Rehabilitation (CORe)
Official title: COPD Online Rehabilitation (CORe) - a Randomized, Multicenter Telemedicine Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: Danish Lung Association
name: Region Capital Denmark
name: University of Copenhagen
First posted: 2016-01-28
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled, assessor- and statistician blinded, superiority, multicentre trial with two parallel-groups. Online COPD Rehab versus Coventional COPD rehab
Primary purpose: TREATMENT

Brief summary: International and national publications emphasize that COPD rehabilitation is a key cornerstone in the standard treatment of COPD, based on more than 15 years of research in COPD rehabilitation. COPD rehabilitation improves quality of life, anxiety and depression and physical function. COPD rehabilitation including special physical training, patient-directed education and smoking cessation is core rehabilitation elements, which today are recommended as mandatory content in standard COPD rehabilitation.

Standard COPD rehabilitation is an established offer in all regions and municipalities in Denmark. It is however a well-known challenge, that persons with the most severe COPD symptoms and co-morbidities are most likely not to receive COPD rehabilitation. Frequent exacerbations, socially isolation, transport distance to rehabilitation are main reasons why people with severe COPD disease deliberately chooses not to receive COPD rehabilitation. Why there at present are no rehabilitation alternatives for patients with the most severe COPD symptoms, supervised COPD Online rehabilitation in groups, delivered by health professionals in the COPD patients' own home via a computer screen could likely encourage more people to participate. The number of RCT's investigating the effect of supervised Online delivered COPD rehabilitation in groups versus established COPD rehabilitation are very limited.

The purpose of this randomized study is to investigate the short-term and long-term efficacy of 10 weeks of online COPD rehabilitation versus conventional supervised COPD rehabilitation in people with severe and very severe COPD. The outcome of the intervention is measured on walking distance, muscle endurance, activity level, quality of life and COPD symptoms respectively. Outcomes are measures before intervention start, end of intervention. This study also collects follow-up update after 3, 6 and 12 month. The follow-up data will be in separate publication.

Hypothesis

1. COPD online rehabilitation provides significant larger improvements than the usual care on walking distance, muscle endurance, activity level, and quality of life and COPD symptoms in people with severe and very severe COPD.
2. COPD online rehabilitation and conventional COPD rehabilitation, provides clinically relevant improvement on walking distance, muscle endurance, activity level, quality of life and COPD symptoms in people with severe and very severe COPD.


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

Exclusion Criteria:

* Concurrent participation in or recent completion of pulmonary rehabilitation within the last six months.
* Dementia/ Cognitive impairment or uncontrolled psychiatric illness,
* An impaired hearing and / or vision which causes the instructions in the rehabilitation is not understood.
* Unable to understand and / or speak Danish.
* Unable to read Danish.
* Severe co-morbidity that are contraindicated to rhe clinical exercise protocol.

Primary outcomes:
measure: Change in 6-Minute Walk Test Distance (6MWT)
timeFrame: baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
Secondary outcomes:
measure: Change in 30 second sit-to-stand test (30-STST)
timeFrame: baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
measure: Change in Activity level (ActivPAL)
timeFrame: Worn by the patients around the clock for 5 days in a private home at baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
measure: Change in Clinical COPD Questionaire (CCQ)
timeFrame: baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
measure: Change in COPD Assessment Test (CAT)
timeFrame: baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
measure: Change in Euro Qol (EQ5D)
timeFrame: baseline (before intervention), after 10 weeks, after 22 weeks (average of 3 month follow up)
measure: Total attendance in rehabilitation
timeFrame: after 10 weeks
measure: number of hospital admissions
timeFrame: number of hospital admissions - after 10 weeks, after 22 weeks (average of 3 month follow up), after 36 weeks (average of 6 month follow up), after 62 weeks (average of 12 month follow up)
measure: Number of hospital days
timeFrame: number of hospital days - after 10 weeks, after 22 weeks (average of 3 month follow up), after 36 weeks (average of 6 month follow up), after 62 weeks (average of 12 month follow up)
measure: Outpatient visits in hospital and at general practioner
timeFrame: number of outpatients visits in hospital and at general practioner - after 10 weeks, after 22 weeks (average of 3 month follow up), after 36 weeks (average of 6 month follow up), after 62 weeks (average of 12 month follow up)
measure: Mortality
timeFrame: after 10 weeks, after 22 weeks (average of 3 month follow up), after 36 weeks (average of 6 month follow up), after 62 weeks (average of 12 month follow up)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital
state: Copenhagen Northwest
city: Copenhagen
country: Denmark
facility: Amager Hospital
city: Frederikssund
country: Denmark
facility: Frederikssund hospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Hillerød
country: Denmark
facility: Hillerød hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Research Unit for Chronic Diseases and Telemedicine
name: Anne Frølich, MD, PhD
role: STUDY_CHAIR
References:
citation: Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
citation: Hansen H, Bieler T, Beyer N, Kallemose T, Wilcke JT, Ostergaard LM, Frost Andeassen H, Martinez G, Lavesen M, Frolich A, Godtfredsen NS. Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial. Thorax. 2020 May;75(5):413-421. doi: 10.1136/thoraxjnl-2019-214246. Epub 2020 Mar 30.
citation: Hansen H, Bieler T, Beyer N, Godtfredsen N, Kallemose T, Frolich A. COPD online-rehabilitation versus conventional COPD rehabilitation - rationale and design for a multicenter randomized controlled trial study protocol (CORe trial). BMC Pulm Med. 2017 Nov 16;17(1):140. doi: 10.1186/s12890-017-0488-1.