Condition category
Respiratory
Date applied
26/03/2013
Date assigned
26/03/2013
Last edited
21/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A recent report suggested that individuals discharged from hospital after an exacerbation (or flare-up) of their Chronic Obstructive Pulmonary Disease (COPD) often feel isolated and have little information about how to manage the disease. In collaboration with healthcare professionals and individuals with COPD, we have developed a comprehensive manual (A Self Management Programme of Activity, Coping and Education [SPACE]) to help people with COPD to understand and manage their lung condition effectively. The manual is divided into four sections (in total 170 pages) and has advice and information on managing breathlessness, staying active, recognising the symptoms of exacerbations, and using medications appropriately. In this study we would like to evaluate the use of the manual upon discharge from hospital. The study aims to evaluate the impact of the manual for individuals with COPD in regards to readmission rates, quality of life and exercise capacity. The SPACE manual will be compared to usual care. Overall, the study is to establish the value of the SPACE manual at the point of discharge for an admission of COPD.

Who can participate?
Patients who have Chronic Obstructive Pulmonary Disease (COPD) who have been admitted to hospital with an exacerbation of their COPD. Patients who are willing, with an MRC dyspnoea grade of 2-5.

What does the study involve?
There are two groups in the study; half of those who agree to take part will receive the SPACE manual and the other half will receive usual care. This is done randomly, i.e. like tossing a coin. For those allocated to receive SPACE, participants will be introduced to the manual while they are still in hospital, and sections that would be most useful to them will be highlighted. When they are discharged home from hospital, they will receive a phone call within 72 hours and at 2, 4, 6, 8, and 10 weeks to monitor their progress and provide further support and advice. For those allocated to receive usual care, participants will receive usual care upon discharge from hospital. All participants will be required to perform an assessment at the start of the study which includes walking tests and completing some questionnaires to find out how their COPD affects them in their daily life. All participants will be reassessed 3 months later, using the same assessment.

What are the possible benefits and risks of participating?
The information we get from this study may help us to treat future patients with COPD. If participants were allocated to the SPACE manual group they would receive a comprehensive information manual about their lung disease and how they might manage it, which they will be able to keep. In both groups of patients we will perform repeated questionnaires, lung function measures and walking tests that will allow us to monitor participants’ recovery. The disadvantages and risks are the same for both groups of patients in the study and are the same as for patients who are not taking part in the study. No disadvantages or risks have been identified.

Where is the study run from?
University Hospitals Coventry and Warwickshire (UK).

When is the study starting and how long is it expected to run for?
The study started in January 2013 and is expected to recruit participants for 1 year.

Who is funding the study?
The British Lung Foundation (UK).

Who is the main contact?
Vicki Johnson, Research Physiotherapist
Vicki.Johnson@uhcw.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Vicki Johnson

ORCID ID

Contact details

PRI Suite
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Vicki.Johnson@uhcw.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13469

Study information

Scientific title

A randomised controlled study for the delivery of standardised self management (SPACE Self management Programme of Activity, Coping and Education) at the time of discharge after an acute exacerbation of COPD - is it effective?

Acronym

SPACE at Discharge for COPD

Study hypothesis

The aim of this project is to provide evidence to support the delivery of a structured self-management programme for patients with an exacerbation (and hospitalised) of chronic obstructive pulmonary disease (COPD). Currently there is no evidence-based self-management strategy available in the UK, over and above exacerbation management advice. Over the last 4 years we have developed a self-management manual, SPACE for COPD (Self Management Programme of Activity, Coping & Education for Chronic Obstructive Pulmonary Disease). It is a structured programme of exercise, education and psychosocial support for individuals with COPD. The hypothesis driving this research project is that a ‘discharge self-management strategy’ is effective at improving health status and physical activity for patients with COPD which would indirectly, favourably influence readmissions, realising greater health benefits compared to usual care.

We will undertake a randomised controlled trial of the intervention. This will be achieved in a pragmatic trial of self management at discharge (SPACE for COPD) vs usual care to assess the impact of the manual on health status, physical activity and other important outcomes.

The primary objective of this study is to establish the value of the space manual at the point of discharge for an admission of COPD.

Secondary aims are:
1. To examine the impact of SPACE for COPD upon readmission rates, in individuals with COPD 3 months after discharge
2. To examine the impact of SPACE for COPD upon quality of life in individuals with COPD 3 months after discharge
3. To examine the impact of SPACE for COPD upon exercise capacity 3 months after discharge
4. To describe the acceptability and appropriateness of self-management manual, SPACE for individuals with COPD who were allocated to the treatment group

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13469

On 21/08/2014 the following changes were made to the trial record:
1. The public title was changed from 'A pilot study for the delivery of standardised self management (SPACE Self management Programme of Activity, Coping and Education) at the time of discharge after an acute exacerbation of COPD - is it effective?' to 'A study for the delivery of standardised self management (SPACE Self management Programme of Activity, Coping and Education) at the time of discharge after an acute exacerbation of COPD - is it effective?'
2. The scientific title was changed from 'A pilot randomised controlled study for the delivery of standardised self management (SPACE Self management Programme of Activity, Coping and Education) at the time of discharge after an acute exacerbation of COPD - is it effective?' to 'A randomised controlled study for the delivery of standardised self management (SPACE Self management Programme of Activity, Coping and Education) at the time of discharge after an acute exacerbation of COPD - is it effective?'

Ethics approval

NRES Committee West Midlands – Solihull, 23/07/2012, ref: 12/WM/0106

Study design

Randomised; Interventional; Design type: Treatment

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 below to request a patient information sheet

Condition

Topic: Respiratory; chronic obstructive pulmonary disease

Intervention

SPACE for COPD versus Usual Care

A Self-Management Programme of Activity, Coping and Education for patients with Chronic Obstructive Pulmonary Disease (COPD). SPACE consists of a manual developed by various healthcare professionals, patients and carers, is underpinned by the health belief model embracing self-efficacy and approved by the Plain English Campaign. It promotes behaviour change through education, developing self-management skills and motivational interviewing techniques, with a focus of increasing physical activity.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Hospital readmissions; Timepoint(s): 3 months

Secondary outcome measures

1. Bristol COPD Knowledge Questionnaire; Timepoint(s): baseline and 3 months
2. Chronic Respiratory Questionnaire; Timepoint(s): baseline and 3 months
3. EUROQOL; Timepoint(s): baseline and 3 months
4. Exercise Capacity - Incremental and Endurance Shuttle Walk Tests; Timepoint(s): baseline and 3 months
5. Physical Activity (SenseWear); Timepoint(s): baseline and 3 months
6. Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE); Timepoint(s): baseline and 3 months

Overall trial start date

07/01/2013

Overall trial end date

07/01/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with an established diagnosis of an exacerbation of COPD and MRC 2-5
2. Willing to take part
3. Male & Female; Lower Age Limit 50 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 86; UK Sample Size: 86

Participant exclusion criteria

1. Inability to participate in interventions designed to improve physical capacity, e.g. neurological, severe cardiac, locomotive, or psychiatric disability
2. Unwilling to participate
3. Participation in other research projects
4. Unable to read English
5. Interventions

Recruitment start date

07/01/2013

Recruitment end date

07/01/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

PRI Suite
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

Coventry University Hospital (UK)

Sponsor details

Clinical Sciences Research Institute
Clinical Sciences Building
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhcw.nhs.uk

Funders

Funder type

Charity

Funder name

British Lung Foundation (UK)

Alternative name(s)

BLF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes