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 |
| Protocol serial number | N0236138972 |
| Sponsor | Department of Health |
| Funder | St George's Healthcare NHS Trust (UK) |
- 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
Scientific
Chest Medicine
St George's Hospital Medical School
Blackshaw Road
Tooting
London
SW17 0RE
United Kingdom
| Phone | +44 (0)20 8725 1275 |
|---|---|
| Samantha.prigmore@stgeorges.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Patients knowledge of the disease and medication |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Chest Medicine
London
SW17 0RE
United Kingdom
SW17 0RE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
20/07/2016: No publications found, verifying study status with principal investigator
