Does an individualised self-management plan help patients with chronic obstructive pulmonary disease (COPD) initiate early treatment for infective exacerbations?

ISRCTN	ISRCTN59758487
DOI	https://doi.org/10.1186/ISRCTN59758487
Secondary identifying numbers	N0236138972

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 20/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Samantha Prigmore
Scientific

Chest Medicine
St George's Hospital Medical School
Blackshaw Road
Tooting
London
SW17 0RE
United Kingdom

Phone	+44 (0)20 8725 1275
Email	Samantha.prigmore@stgeorges.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Does an individualised self-management plan help patients with chronic obstructive pulmonary disease (COPD) initiate early treatment for infective exacerbations?
Study objectives	To assess the effectiveness of an individualised self management plan to see if it improves patients ability to recognise early signs of an infection and self initiate treatment during an exacerbation
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Respiratory: Chronic obstructive pulmonary disease (COPD)
Intervention	Methodology An experimental approach will be taken, using a randomised controlled trial. Participants (sample group of 40 - 20 to each arm of the study), with a diagnosis of COPD attending the nurse-led clinic at St George's Healthcare NHS Trust will be randomly selected to receive routine care versus intervention, consisting of education, issuing of a self-management leaflet, symptom card and a prescription for antibiotics and cortico-steroids. Both arms will be asked to complete two questionnaires pre and 1 month post intervention, with the intervention arm being asked to complete a symptom diary for 6 months. Randomisation will be undertaken through using sealed envelopes. Permission is being sought from the Wandsworth Local Research Ethics Committee. Data Collection All patients will be asked to complete two questionnaires 1. The COPD self efficacy questionnaire (validated) (Wigal 1991) 2. A 20 question multiple choice questionnaire on the treatment of COPD 3. Demographic will be collected including severity of disease, age, sex, number of exacerbations and admissions for COPD in the previous year. The aim is to test the participants' knowledge of COPD, its treatment, recognition of exacerbations, and confidence in self management. Data Analysis Data will be analysed using the Statistical Package for the Social Sciences (SPSS), using a paired T-test to analyse the questionnaires pre and post intervention. An unpaired test will compare the two groups. Any correlation between age, sex and severity of disease exacerbation and admission rate will be explored.
Intervention type	Other
Primary outcome measure	Patients knowledge of the disease and medication
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2004
Completion date	30/09/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	40
Key inclusion criteria	Random selection using sealed envelopes to either arm of the study. Diagnosis of COPD attending nurse led clinics at Chest Clinic St Georges Hospital.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/01/2004
Date of final enrolment	30/09/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Chest Medicine

London
SW17 0RE
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

St George's Healthcare NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

20/07/2016: No publications found, verifying study status with principal investigator