ISRCTN - ISRCTN63986906: The COPD Breathlessness Manual: Cognitive-behavioural manual versus information booklets on health service use, mood and health status in patients with chronic obstructive pulmonary disease (COPD)

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease (COPD) is a costly long term condition associated with frequent Accident & Emergency (A&E) and hospital admissions. Psychological difficulties such as anxiety, panic and depression, which are high in COPD as well as inadequate self-management, can amplify this picture. We are carrying out a study to evaluate a newly developed cognitive-behavioural guided self-help intervention called The COPD Breathlessness Manual which targets the psychological management of breathlessness and COPD in the context of preventing unnecessary A&E attendance and hospital admissions. The COPD breathlessness manual will be compared to information booklets to see if it is more effective at reducing hospital use and associated NHS costs as well as improving mood and health status.

Who can participate?
The COPD manual study aims to recruit about 220 men and women, with a confirmed diagnosis of COPD and a self-rating of moderate breathlessness from a range of GP practices in a London Borough.

What does the study involve?
Over a period of 1.5 years participants will be invited by letter to participate in the trial. Opt
ins will be telephoned to discuss the trial, check they meet the criteria and to arrange a home visit. The group to which a participant is allocated to will be decided by a process called randomisation, which is like a coin toss. Both groups will receive a 90 minute home visit involving obtaining signed informed consent, measures at the start of the study, a semi-structured interview, and introducing the intervention. Participants will be encouraged to follow their programme at home for approximately one hour per day (broken up throughout the day) over a five week period. They will receive two 30 minute telephone call booster sessions at week three and six.
At the end of the study, we will compare the number of A&E attendances, hospital admission, length of stay and associated NHS costs 12 months before study participation and 12 months afterwards. We will also measure anxiety, depression and health status at the start of the study, at 6 weeks on completion of the intervention as well as six months. We will collect participant feedback on their intervention.

What are the possible benefits and risks of participating?
The intended benefit is that by focusing on and learning more about breathlessness and COPD it will reduce the severity of breathlessness and any anxiety and frustration associated with it. It may also reduce the amount of medical care required. It is possible that focusing on breathlessness may mean participants are more aware of it. Further support can be arranged if necessary.

Where is the study run from?
The study was set up by the Department of Clinical Health Psychology at The Hillingdon Hospital, Central & North West London NHS Foundation Trust (UK). The participants come from a number of GP practices in a London Borough.

When is study starting and how long is it expected to run for?
From August 2010 to July 2012. Recruitment started mid-2011 and participants were enrolled for one year.

Who is funding the study?
Funding has been provided by Central & North West London NHS Foundation Trust (UK).

Who is the main contact?
Dr Simon Dupont, simon.dupont@nhs.net
Dr Claire Howard, choward1@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon Dupont

ORCID ID

http://orcid.org/0000-0002-1467-8037

Contact details

Department of Clinical Health Psychology
The Hillingdon Hospital
Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom
+44 20 7932 3100
simon.dupont@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HOWCC10001

Study information

Scientific title

The COPD Breathlessness Manual: A randomised controlled trial to test a cognitive-behavioural manual versus information booklets on health service use, mood and health status in patients with chronic obstructive pulmonary disease

Acronym

COPD Manual

Study hypothesis

Hypothesis:
The COPD breathlessness manual will result in a greater reduction in A&E visits, hospital admissions and length of stay as well as a greater improvement in mood and health status compared to information booklets.

Null hypothesis:
There will be no difference between groups on outcomes.

Ethics approval

Central London REC 3 Research Ethics Committee, 24/05/2010, ref: 10/H0716/22

Study design

One year parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet: simon.dupont@nhs.net or choward1@nhs.net

Condition

Chronic Obstructive Pulmonary Disease

Intervention

Participants will be randomised to receive either The COPD Breathlessness Manual: A cognitive behavioural guided self help manual or COPD information booklets. They will be guided through their intervention by a facilitator in the form of one home visit and two telephone call follow ups. They will be encouraged to work through their intervention in their own time at home over a five week period.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The change in the number of A&E attendances over a 12 month period from pre to post intervention.

Secondary outcome measures

The change in number of hospital admissions, number of hospital bed days, anxiety, depression and health status pre and post intervention. Mood and health status were collected with questionnaires at timepoints baseline, 6 weeks and 6 months.

Overall trial start date

01/08/2010

Overall trial end date

31/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. A diagnosis of COPD
2. A self-rating of breathlessness on the Medical Research Council (MRC) dyspnoea scale of 3,4 or 5
3. Willingness to participate
4. Ability to provide informed consent
5. Ability to read and write in English or with assistance

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Known psychosis and personality disorders
2. Receiving psychological therapy
3. Participating in Pulmonary Rehabilitation or within the previous six months
4. Cognitive impairment, dementia
5. Verbal and/or written communication problems

Recruitment start date

01/08/2010

Recruitment end date

31/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Clinical Health Psychology
Uxbridge
UB8 3NN
United Kingdom

Sponsor information

Organisation

Central & North West London NHS Foundation Trust (UK)

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type