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 and taking medications can alleviate symptoms. New skills such as how to exercise, how to manage their stress and how to manage their breathing are important to learn. SPACE FOR COPD is a manual which aims to teach people these skills, and to provide them with information about their condition and how best to manage it. A previous research study showed that there were clear benefits to using the manual in the short term, and some of these gains were maintained after 6 months. In this study, however, the treatment period was brief, with only an initial consultation of 30-45 minutes. The added benefit of more sustained ongoing support should be tested. It is now important to investigate whether these improvements can be better maintained in the longer term, and also if the manual can be given to patients as part of routine clinical care, rather than as part of a research study.
Who can participate?
Adults diagnosed with COPD
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are given the SPACE FOR COPD manual in group settings in the community. Those in group 2 are given their usual care and do not receive the SPACE FOR COPD manual. We assess participants at the start of the study, after 6 months and after 9 months to investigate both the short-term and longer-term effects of the self-management manual.
What are the possible benefits and risks of participating?
The benefits of participating within this study involve gaining a better understanding of COPD and how patients can improve their symptoms. Information gathered from the patients will aid and inform both current and future research, and aim to provide better care for patients living with COPD. There are no anticipated risks of participating in the research project.
Where is the study run from?
Glenfield Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2015 to September 2017
Who is funding the study?
1. Collaboration for Leadership in Applied Health Research and Care East Midlands (UK)
2. Academic Health Science Network East Midlands (UK)
Who is the main contact?
Sally Singh
Sally.Singh@uhl-tr.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Sally Singh
ORCID ID
Contact details
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
-
Sally.Singh@uhl-tr.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A self-management programme of activity coping and education - SPACE FOR COPD - in primary care: a prospective, pragmatic, single-centre, single-blinded randomised controlled trial
Acronym
N/A
Study hypothesis
SPACE for COPD delivered by a trained facilitator in groups will significantly improve breathlessness compared to usual care.
Ethics approval
NRES Committee South Central - Hampshire B, 21/10/2014, IRAS: 152408, REC ref: 14/SC/1169
Study design
Single-centre single-blinded randomised controlled trial, sub-study of semi-structured qualitative interviews with the HCPs that delivered the intervention
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 the contact details to request a patient information sheet
Condition
Chronic obstructive pulmonary disease (COPD), self management
Intervention
Those randomised to the SPACE group will be given the SPACE manual and will receive six group sessions in the community delivered by trained healthcare professionals going through various topics related towards goal setting. Those randomised to usual care will have no change in their care and will not receive the SPACE FOR COPD manual.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
COPD Assessment Test (CAT) at baseline, 6 months and 9 months
Secondary outcome measures
1. The Chronic Respiratory Questionnaire Self Report (CRQ-SR) at baseline, 6, 9 months for both groups
2. The Patient Activation Measure (PAM) at baseline, 6, 9 months for both groups
3. The Hospital Anxiety and Depression Scale (HADS) at baseline, 6, 9 months for both groups
4. The Bristol COPD Knowledge Questionnaire (BCKQ) at baseline, 6, 9 months for both groups
5. Exercise performance (The Incremental Shuttle Walk Test and Endurance Shuttle Walking Test) at baseline, 6, 9 months for the interventional group, at 9 months only for the usual care group
6. The EQ-5D throughout the study
7. Healthcare utilisation throughout the study
8. Smoking status throughout the study
9. Physical activity via the SenseWear Armband (SAB) at baseline, 6, 9 months for both groups
Overall trial start date
01/01/2015
Overall trial end date
30/09/2017
Reason abandoned
Eligibility
Participant inclusion criteria
Established diagnosis of COPD
Participant type
Patient
Age group
All
Gender
Both
Target number of participants
193
Participant exclusion criteria
1. Unable to participate in exercises component of rehabilitation, e.g. neurological, locomotive or psychiatric disability
2. Unable to read English to the level of an 8 year old
3. Unwilling to take part
4. Has received or participated in the Pulmonary Rehabilitation or received the SPACE manual within the last 12 months
Recruitment start date
01/01/2015
Recruitment end date
02/11/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
Sponsor information
Organisation
Leicester General Hospital (UK)
Sponsor details
c/o Carolyn Maloney
Research and Development Office
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
-
RDAdmin@uhl-tr.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Collaboration for Leadership in Applied Health Research and Care East Midlands (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Academic Health Science Network East Midlands (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The trialists aim to publish the protocol and results of the trial. They also aim to publish a qualitative paper from this study also looking at Health Care Professionals' experiences and thoughts on delivering the SPACE manual in group settings.
Intention to publish date
30/06/2018
Participant level data
Not expected to be available
Results - basic reporting
Publication summary