Study Title: Patient self-management in primary care patients with COPD - a randomised
controlled trial (PSM COPD)
Local CRN Contact: Aman Johal
Tel: 02476 574127
Email: Amanpreet.Johal@warwick.ac.uk
Trial Co-ordinator: Manbinder (Manni) Sidhu
Tel:
0121 414 7895
Email: m.s.sidhu@bham.ac.uk
Funder: National Institute for Health Research, School for Primary Care Research
Type of Study: Multi-centre, randomised controlled trial
Why is this research being carried out?
There is an absence of research evidence with regard to the effectiveness of self-management
interventions in primary care for people who report only mild symptoms of their COPD. Recent
interest in COPD case finding in primary care, driven by the new National Clinical Outcomes
Strategy for COPD, will result in identified patients who are not eligible for pulmonary rehabilitation.
Study Aims: The research aims to determine whether a telephone-based self-care intervention
for patients who display symptoms of mild dyspnoea, improves health-related quality of life and
health behaviours at 12 months follow-up, compared to people allocated to usual primary care.
This study aims to inform care for this patient group and potentially slow the progression of their
condition by advising lifestyle changes.
Number of Patients Needed:

Overall target 550 Patients, approximately recruiting 10 patients per GP practice within
Worcestershire
Practice Involvement in the Study:





The Practice / Clinical Research Network (CRN) conduct a patient search on the practice
medical system to identify potentially eligible patients
GP to check list
The Practice/CRN to conduct mail merge and send out postal invitations to identified
patients; materials and costs associated with this will be provided by the research
team
The Practice to communicate with the research team to organise a clinic room
Please note that practice staff WILL NOT have to administer any questionnaires, book
appointments for study clinics or train patients in self-management
Patient Involvement





Patients respond to an invitation letter directly to the trial team who are based at the
University of Birmingham
If eligible, patients will be booked in for a baseline assessment at the Practice and the
appointment will be with the Study team
Spirometery, height and weight measurements will be taken
Eligible patients will then be randomly allocated to usual primary care management or a
telephone and postal-based intervention delivered by the study nurse
Patients randomised to the telephone- based-self-care intervention will receive advice and
support on smoking cessation, physical activity, adherence to medication, correct inhaler
technique and action planning
Study Team Involvement in the Study:
The study team will;




Deal with any queries from patients or practices
Consent and randomise eligible patients
Provide all equipment and paperwork to conduct the trial including costs associated to postal
invitations
Manage and conduct all research clinics
Inclusion Criteria: Patients who have COPD and are MRC grade 1 or 2
Exclusion Criteria: Patients who are MRC grade 3, 4, or 5; Patients with FEV1/FVC>0.7; NonEnglish speaking
Benefits to the practice in taking part
•The study team will assist with COPD QOF targets (COPD002, COPD003, and COPD004)
•Spirometry assessment for your patients who are MRC1 and 2
•Updated BMI for your patients according to NICE guidelines
Reimbursement: An estimated NHS Service support cost payment of £227.65 has been
calculated for this study. This figure is based upon the information provided by the study team
regarding the likely activities to be performed by your Practice; it is an approximation only and may
be adjusted in line with the amount of patient recruitment and the level of CRN support received.
Room hire will be reimbursed at local NHS Service Support cost rates by the study team,
this is approximately £15 per hour dependent on the number of patients recruited
For further details contact: Aman Johal Tel: 02476 574127
Amanpreet.Johal@warwick.ac.uk
Delivering research to make patients, and the NHS, better