Condition category
Respiratory
Date applied
17/11/2014
Date assigned
11/02/2015
Last edited
17/10/2016
Prospective/Retrospective
Retrospectively 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 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 June 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

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Established diagnosis of COPD

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

150

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

We aim to publish the protocol and results of the trial. We 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

Publication citations

Additional files

Editorial Notes

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