Condition category
Respiratory
Date applied
21/11/2013
Date assigned
21/11/2013
Last edited
01/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

University of Birmingham

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25778520
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25880414

Publication citations

Additional files

Editorial Notes

01/09/2016: the overall trial end date was changed from 30/09/2015 to 30/12/2016.