A self-management programme of activity coping and education - SPACE FOR COPD - in primary care: a pragmatic trial

ISRCTN	ISRCTN17942821
DOI	https://doi.org/10.1186/ISRCTN17942821
Protocol serial number	N/A
Sponsor	Leicester General Hospital (UK)
Funders	Collaboration for Leadership in Applied Health Research and Care East Midlands (UK), Academic Health Science Network East Midlands (UK)

Submission date: 17/11/2014
Registration date: 11/02/2015
Last edited: 07/03/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Sally Singh
Scientific

Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom

Email	Sally.Singh@uhl-tr.nhs.uk

Study information

Primary study design	Interventional
Study design	Single-centre single-blinded randomised controlled trial, sub-study of semi-structured qualitative interviews with the HCPs that delivered the intervention
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	N/A
Study objectives	SPACE for COPD delivered by a trained facilitator in groups will significantly improve breathlessness compared to usual care.
Ethics approval(s)	NRES Committee South Central - Hampshire B, 21/10/2014, IRAS: 152408, REC ref: 14/SC/1169
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	COPD Assessment Test (CAT) at baseline, 6 months and 9 months
Key secondary outcome measure(s)	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
Completion date	30/09/2017

Eligibility

Participant type(s)	Patient
Age group	All
Sex	All
Target sample size at registration	193
Key inclusion criteria	Established diagnosis of COPD
Key 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
Date of first enrolment	01/01/2015
Date of final enrolment	02/11/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Glenfield Hospital

Groby Road
Leicester
LE3 9QP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		10/07/2017	07/03/2023	Yes	No
Basic results		23/10/2018	23/10/2018	No	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN17942821_BasicResults_23Oct2018.pdf: Uploaded 23/10/2018

Editorial Notes

07/03/2023: Publication reference added.
23/10/2018: The basic results of this trial have been uploaded as an additional file
15/08/2017: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/06/2017 to 30/09/2017.
2. The target number of participants was changed from 150 to 193.
14/10/2016: The recruitment end date has been updated from 30/09/2015 to 02/11/2016 and the overall trial end date has been updated from 30/09/2016 to 30/06/2017.