Condition category
Respiratory
Date applied
14/01/2015
Date assigned
15/01/2015
Last edited
08/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 January 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Ms Sarah Jones

Trial website

Contact information

Type

Scientific

Primary contact

Ms Sarah Jones

ORCID ID

Contact details

Royal Brompton & Harefield NHS trust
Harefield Hospital
Hill End Road
Harefield
Uxbridge
UB9 6JH
United Kingdom

Additional identifiers

EudraCT 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

London – City and East, 18/11/2014, ref: 14/LO/1740

Study design

Randomised; Interventional and Observational

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Topic: Respiratory disorders; Subtopic: Respiratory (all Subtopics); Disease: Respiratory

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

Other

Phase

Drug names

Primary outcome measures

Uptake is defined as attending an initial assessment for pulmonary rehabilitation.

Secondary outcome measures

N/A

Overall trial start date

26/01/2015

Overall trial end date

25/01/2017

Reason abandoned

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-metres; no evidence of acute coronary syndrome or unstable ischaemic heart disease or any condition that would make exercise unsafe).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200

Participant exclusion criteria

1. Unable to walk 5-metres 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

31/07/2016

Locations

Countries of recruitment

United Kingdom

Trial 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
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes