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?
| ISRCTN | ISRCTN84599369 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84599369 |
| Secondary identifying numbers | 13469 |
- Submission date
- 26/03/2013
- Registration date
- 26/03/2013
- Last edited
- 06/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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 receive the SPACE manual and the other half receive usual care. This is done randomly, i.e. like tossing a coin. For those allocated to receive SPACE, participants are introduced to the manual while they are still in hospital, and sections that would be most useful to them are highlighted. When they are discharged home from hospital, they 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 receive usual care upon discharge from hospital. All participants are 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 are reassessed 3 months later, using the same assessment.
What are the possible benefits and risks of participating?
The information from this study may help to treat future patients with COPD. If participants are allocated to the SPACE manual group they receive a comprehensive information manual about their lung disease and how they might manage it, which they can keep. In both groups of patients repeated questionnaires, lung function measures and walking tests are performed 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?
January 2013 to January 2014
Who is funding the study?
The British Lung Foundation (UK)
Who is the main contact?
Vicki Johnson
Vicki.Johnson@uhcw.nhs.uk
Contact information
Scientific
PRI Suite
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
| Vicki.Johnson@uhcw.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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? |
| Study acronym | SPACE at Discharge for COPD |
| Study objectives | 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. The trialists 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 |
| Ethics approval(s) | NRES Committee West Midlands Solihull, 23/07/2012, ref: 12/WM/0106 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 07/01/2013 |
| Completion date | 07/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 86; UK Sample Size: 86 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 07/01/2013 |
| Date of final enrolment | 07/01/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CV2 2DX
United Kingdom
Sponsor information
Hospital/treatment centre
Clinical Sciences Research Institute
Clinical Sciences Building
Clifford Bridge Road
Coventry
CV2 2DX
England
United Kingdom
| Website | http://www.uhcw.nhs.uk |
|---|---|
"ROR" |
https://ror.org/025821s54 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- BLF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/06/2016 | Yes | No |
Editorial Notes
06/04/2017: Publication reference added.
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?'
