Plain English Summary
Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name used to refer to a number of progressive devastating and debilitating lung diseases, which includes chronic bronchitis, emphysema and chronic obstructive airways disease. People that have COPD typically feel breathless after physical activity, have a persistent cough with phlegm and suffer frequently from chest infections. There is no cure for the condition, but making lifestyle changes (such as stopping smoking) and taking medications (inhalers and/or tablets) can alleviate symptoms. Pulmonary rehabilitation (PR), a programme of physical exercise and education, can also help people manage their condition and lead to improvements in health. Recent evidence suggests that providing PR shortly after a hospital admission for an acute exacerbation (worsening of symptoms) helps with breathing, quality of life and walking ability. It also reduces the risk of being admitted to hospital in the future. However, a recent study suggests that high numbers of patients hospitalised with an acute exacerbation of COPD (AECOPD) and offered PR turn down this treatment as many do not understand what PR involves and think they are too ill to exercise. We want to find out whether showing a patient-designed video to patients hospitalised with an AECOPD can significantly increase the number of patients taking up early pulmonary rehabilitation following their discharge from hospital.
Who can participate?
Adults over the age of 40, diagnosed with COPD living in the borough of Hillingdon, admitted to hospital with AECOPD and fit enough to take part in PR.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (control group) are given standard verbal information about early pulmonary rehabilitation and a leaflet about pulmonary rehabilitation. Those in group 2 (intervention group) are also provided with the standard verbal information about early pulmonary rehabilitation and leaflet. However, they are also asked to watch a 5 minute patient-designed video promoting early pulmonary rehabilitation.
What are the possible benefits and risks of participating?
There are no direct benefits to the patients taking part in this research. However, the information that we gain from this study will help improve the treatment of patients hospitalised with an exacerbation of COPD. There are no significant risks associated with participating in this research study.
Where is the study run from?
Harefield Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2015 to July 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Ms Sarah Jones
Study website
Contact information
Type
Scientific
Contact name
Ms Sarah Jones
ORCID ID
Contact details
Royal Brompton & Harefield NHS trust
Harefield Hospital
Hill End Road
Harefield
Uxbridge
UB9 6JH
United Kingdom
Type
Public
Contact name
Ms Ruth Barker
ORCID ID
Contact details
Harefield Hospital
Hill End Road
Harefield
UB9 6JH
United Kingdom
+44 01895 823737 x5332/5322
R.Barker2@rbht.nhs.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
18104
Study information
Scientific title
Video to Increase RehabiliTation Uptake following hospitalised Exacerbations of COPD: a randomised controlled trial
Acronym
VIRTUE
Study hypothesis
The aim of the research study is to determine whether delivering a patient designed video to hospitalised patients with an acute excaerbation of COPD (AECOPD) can increase the uptake of early pulmonary rehabilitation following hospital discharge.
Ethics approval(s)
London – City and East, 18/11/2014, ref: 14/LO/1740
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Chronic obstructive pulmonary disease
Intervention
1. Control Group: Standard verbal information about early pulmonary rehabilitation will be provided to the patient, supplemented by an A5 leaflet about pulmonary rehabilitation
2. Intervention Group: Participants will be provided with standard verbal information about early pulmonary rehabilitation, supplemented by an A5 patient information leaflet about pulmonary rehabilitation. They will also be asked to watch a 5 minute patient-designed video promoting early pulmonary rehabilitation
Intervention type
Behavioural
Primary outcome measure
Uptake is defined as attending an initial assessment for pulmonary rehabilitation.
Secondary outcome measures
N/A
Overall study start date
26/01/2015
Overall study end date
17/05/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults over the age of 40, with a known diagnosis of COPD living in the borough of Hillingdon.
2. Adults admitted to Hillingdon Hospital with a primary diagnosis of an acute exacerbation of COPD or a primary diagnosis of pneumonia and a secondary diagnosis of acute exacerbation of COPD.
3. Eligible for post-hospitalisation early pulmonary rehabilitation (able to walk 5 m; no evidence of acute coronary syndrome or unstable ischaemic heart disease or any condition that would make exercise unsafe).
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
Planned Sample Size: 200; UK Sample Size: 200
Total final enrolment
196
Participant exclusion criteria
1. Unable to walk 5 m without assistance
2. Unstable cardiac condition that would make exercise unsafe
3. Unable to consent due to cognitive dysfunction or poor English
4. Receiving palliative care with expectation of death within 3 months
Recruitment start date
26/01/2015
Recruitment end date
17/05/2018
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Royal Brompton & Harefield NHS trust
Harefield Hospital
Hill End Road
Harefield
Uxbridge
UB9 6JH
United Kingdom
Sponsor information
Organisation
Royal Brompton & Harefield NHS trust
Sponsor details
Clinical Trials and Evaluation Unit
Sydney Street
London
SW3 6NP
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal within 1 year of completion of the study, by July 2019.
Intention to publish date
01/07/2019
Individual participant data (IPD) sharing plan
The data sharing plans for the current study are unknown and will be made available at a later date.
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/06/2020 | 11/05/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |