Contact information
Type
Scientific
Primary contact
Ms Samantha Prigmore
ORCID ID
Contact details
Chest Medicine
St George's Hospital Medical School
Blackshaw Road
Tooting
London
SW17 0RE
United Kingdom
+44 (0)20 8725 1275
Samantha.prigmore@stgeorges.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0236138972
Study information
Scientific title
Does an individualised self-management plan help patients with chronic obstructive pulmonary disease (COPD) initiate early treatment for infective exacerbations?
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Patients knowledge of the disease and medication
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2004
Overall trial end date
30/09/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
40
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/01/2004
Recruitment end date
30/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Chest Medicine
London
SW17 0RE
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
St George's Healthcare NHS Trust (UK)
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
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary