Condition category
Respiratory
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
20/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

Publication citations

Additional files

Editorial Notes

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