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
Secondary identifying numbers N/A
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

Study designSingle-centre single-blinded randomised controlled trial, sub-study of semi-structured qualitative interviews with the HCPs that delivered the intervention
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA 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 acronymN/A
Study objectivesSPACE 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) studiedChronic obstructive pulmonary disease (COPD), self management
InterventionThose 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 typeBehavioural
Primary outcome measureCOPD Assessment Test (CAT) at baseline, 6 months and 9 months
Secondary outcome measures1. 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 study start date01/01/2015
Completion date30/09/2017

Eligibility

Participant type(s)Patient
Age groupAll
SexBoth
Target number of participants193
Key inclusion criteriaEstablished diagnosis of COPD
Key exclusion criteria1. 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 enrolment01/01/2015
Date of final enrolment02/11/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom

Sponsor information

Leicester General Hospital (UK)
Hospital/treatment centre

c/o Carolyn Maloney
Research and Development Office
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom

Email RDAdmin@uhl-tr.nhs.uk
ROR logo "ROR" https://ror.org/02zg49d29

Funders

Funder type

Government

Collaboration for Leadership in Applied Health Research and Care East Midlands (UK)

No information available

Academic Health Science Network East Midlands (UK)

No information available

Results and Publications

Intention to publish date30/06/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe 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.
IPD sharing planNot provided at time of registration

Study outputs

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

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.