Patient self-management in primary care patients with chronic obstructive pulmonary disease (COPD)
| ISRCTN | ISRCTN06710391 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06710391 |
| Secondary identifying numbers | 14642 |
- Submission date
- 21/11/2013
- Registration date
- 21/11/2013
- Last edited
- 26/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
We are conducting a study to find out the effectiveness of a nurse-led telephone-based self-management service that is designed to help people living with chronic obstructive pulmonary disorder (COPD) to improve their health-related quality of life. Findings generated from the study will contribute to existing research evidence and inform the design of self-management methods in GP surgeries for people who report only mild symptoms of their COPD.
Who can participate?
Adult patients with COPD can take part in this study.
What does the study involve?
Patients will be randomly allocated to one of two groups: self-management package or usual care. The package will include smoking cessation advice; encouragement to become physically active; medication adherence and for those patients with recurrent chest infections, action planning to identify an exacerbation early. It will be delivered by telephone by a nurse with one initial 45-60 minute consultation followed by three 15-20 minute telephone contacts over a three-month period (at about 3, 7 and 11 weeks) with individually tailored written supportive materials following telephone contacts. Data will be collected at 6 and 12 months after allocation.
What are the possible benefits and risks of participating?
Participants will receive support to self-manage their COPD. Further information about NHS services will be provided upon request. There are no known risks in taking part in this study.
Where is the study run from?
This study is run across four sites in the UK: University of Birmingham, University of Keele, University of Manchester and the University of Oxford. These four sites will be working in collaboration with general practices in their localities.
When is the study starting and how long is it expected to run for?
September 2013 to December 2016
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
1. Professor Kate Jolly (c.b.jolly@bham.ac.uk)
2. Professor David Fitzmaurice (d.a.fitzmaurice@bham.ac.uk)
3. Dr Manbinder Sidhu (m.s.sidhu@bham.ac.uk)
Contact information
Scientific
Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
| m.s.sidhu@bham.ac.uk |
Scientific
Public Health Building
School of Health & Population Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 7552 |
|---|---|
| c.b.jolly@bham.ac.uk |
Study information
| Study design | Both; Interventional; Design type: Process of Care, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Patient self-management in primary care patients with chronic obstructive pulmonary disease (COPD): a randomised controlled trial |
| Study acronym | PSM-COPD |
| Study objectives | The study will commence with a feasibility study followed by a randomised controlled trial of a telephone-based self-management intervention compared with usual care. The feasibility study aims to check that the training package is appropriate and sufficient for the delivery of the intervention; that uptake and adherence to the intervention are sufficiently high; that the respiratory questionnaires are appropriate for people with mild COPD and to obtain insights into the patient experience of receiving the self-management intervention and how the intervention may affect costs and health outcomes. RCT: Randomisation will be performed centrally by computer at the Primary Care Clinical Trials Unit, University of Birmingham. The RCT will comprise a telephone-based self-management package of 4 components compared with usual care. The 4 components are smoking cessation, promotion of physical activity, medication adherence and action planning. The primary outcome is HRQoL measured using the St Georges Respiratory Questionnaire (SGRQ). |
| Ethics approval(s) | 13/WM/0206; First MREC approval date 16/07/2013 |
| Health condition(s) or problem(s) studied | Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases |
| Intervention | Patients will be randomised to the intervention or usual care in the main trial with a 1:1 ratio. Supported self-management, Nurse-supported telephone self-management. Self-management includes 4 elements: smoking cessation, physical activity, correct inhaler technique and action planning for an exacerbation.; Follow Up Length: 12 month(s); Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure | St George's Respiratory Questionnaire (SGRQ); Timepoint(s): 6 and 12 months follow-up |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 16/09/2013 |
| Completion date | 30/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 553; UK Sample Size: 553; Description: Up to 30 patients will be recruited for the feasibility study, and 553 will be recruited on to the main trial. |
| Key inclusion criteria | On COPD primary care register with MRC dyspnoea grade 1 and 2 Target Gender: Male & Female ; Lower Age Limit 18 years |
| Key exclusion criteria | 1. COPD MRC grade 3 and above 2. COPD unconfirmed by post-bronchodilator spirometry (FEV1/FVC ration above 5th percentile of the predicted values for their age, height, sex and ethnicity, using the ECCS equations) |
| Date of first enrolment | 18/03/2014 |
| Date of final enrolment | 05/02/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Edgbaston
Birmingham
B15 2TT
United Kingdom
Williamson Building
Oxford Road
Manchester
M13 9PL
United Kingdom
New Radcliffe House
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
Staffordshire
ST5 5BG
United Kingdom
Sponsor information
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
"ROR" |
https://ror.org/03angcq70 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/12/2017 |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/02/2015 | Yes | No | |
| Results article | results | 13/06/2018 | Yes | No | |
| Results article | SWAT results | 24/07/2019 | 26/07/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
26/07/2019: Publication reference added.
19/06/2018: Publication reference added.
01/09/2016: The overall trial end date was changed from 30/09/2015 to 30/12/2016.
