Measurement of, and psychological intervention with, partial adherence to inhaled antibiotic therapies in adults with cystic fibrosis
| ISRCTN | ISRCTN86935165 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86935165 |
| Protocol serial number | N0436130480 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 11/07/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss J E Quinn
Scientific
Scientific
Academic Unit Psychiatry & Behavioural Sciences
15 Hyde Terrace
University of Leeds
Leeds
LS2 9LN
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 1. To determine factors that affect adherence to nebuliser treatment in cystic fibrosis patients 2. To evaluate a psychological intervention designed to improve adherence in those whose adherence is less than 80% |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Cystic fibrosis |
| Intervention | Database analysis; Questionnaire; Randomised controlled trial ( psychological intervention versus no psychological intervention); Before-after trial. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. The difference in adherence pre and post intervention. This will be measured using the ProDose adaptive aerosol delivery system, which records patient usage data |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Key inclusion criteria | 1. Male and female patients with a diagnosis of cystic fibrosis 2. 18+ years of age 3. Taking nebulised colistin through the ProDose Adaptive Aerosol Delivery (AAD) system for cystic fibrosis 4. Able to use a nebuliser mouthpiece |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 01/11/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Academic Unit Psychiatry & Behavioural Sciences
Leeds
LS2 9LN
United Kingdom
LS2 9LN
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2009 | Yes | No |
