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)

ISRCTN ISRCTN63986906
DOI https://doi.org/10.1186/ISRCTN63986906
Secondary identifying numbers HOWCC10001
Submission date
24/04/2014
Registration date
01/05/2014
Last edited
13/02/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Simon Dupont
Scientific

Department of Clinical Health Psychology
The Hillingdon Hospital
Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom

ORCiD logoORCID ID 0000-0002-1467-8037
Phone +44 20 7932 3100
Email simon.dupont@nhs.net

Study information

Study designOne year parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant 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
Scientific titleThe 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
Study acronymCOPD Manual
Study objectivesHypothesis:
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(s)Central London REC 3 Research Ethics Committee, 24/05/2010, ref: 10/H0716/22
Health condition(s) or problem(s) studiedChronic Obstructive Pulmonary Disease
InterventionParticipants 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 typeOther
Primary outcome measureThe change in the number of A&E attendances over a 12 month period from pre to post intervention.
Secondary outcome measuresThe 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 study start date01/08/2010
Completion date31/07/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants200
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/08/2010
Date of final enrolment31/07/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Clinical Health Psychology
Uxbridge
UB8 3NN
United Kingdom

Sponsor information

Central & North West London NHS Foundation Trust (UK)
Hospital/treatment centre

Central and North West London NHS Foundation Trust Innovation Scheme
Trust Headquarters
Stephenson House
75 Hampstead Road
London
NW1 2PL
England
United Kingdom

Phone +44 20 3214 5700
Email cnwl.innovations@nhs.net
ROR logo "ROR" https://ror.org/05drfg619

Funders

Funder type

Hospital/treatment centre

Central & North West London NHS Foundation Trust (UK) - Innovations Scheme; Application number 19

No information available

Results and Publications

Intention to publish date31/10/2014
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planPlanned publication in a peer reviewed journal.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 16/10/2014 Yes No

Editorial Notes

13/02/2017: Publication reference added.