Plain English Summary
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)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Manbinder Sidhu
ORCID ID
Contact details
Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
m.s.sidhu@bham.ac.uk
Type
Scientific
Additional contact
Prof Kate Jolly
ORCID ID
Contact details
Public Health Building
School of Health & Population Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7552
c.b.jolly@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14642
Study information
Scientific title
Patient self-management in primary care patients with chronic obstructive pulmonary disease (COPD): a randomised controlled trial
Acronym
PSM-COPD
Study hypothesis
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
13/WM/0206; First MREC approval date 16/07/2013
Study design
Both; Interventional; Design type: Process of Care, Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
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: 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
Phase
Not Applicable
Drug names
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 trial start date
16/09/2013
Overall trial end date
30/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
On COPD primary care register with MRC dyspnoea grade 1 and 2
Target Gender: Male & Female ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
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.
Participant 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)
Recruitment start date
18/03/2014
Recruitment end date
05/02/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Primary Care Clinical Sciences
School of Health and Population Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
Trial participating centre
The University of Manchester
Centre for Primary Care: Institute of Population Health
Williamson Building
Oxford Road
Manchester
M13 9PL
United Kingdom
Trial participating centre
Nuffield Department of Primary Care Health Sciences
University of Oxford
New Radcliffe House
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
Trial participating centre
Research Institute for Primary Care & Health Sciences
Keele University
Staffordshire
ST5 5BG
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - School for Primary Care Research; Grant Codes: 174
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
30/12/2017
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25778520
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25880414
2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29899047