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 |
| Secondary identifying numbers | N0436130480 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 2. The relationship between adherence and clinical outcome such as forced expiratory volume (FEV1), use of additional antibiotic treatment and patients' own psychopathology (measured using questionnaires) |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/2003 |
| Completion date | 01/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
Academic Unit Psychiatry & Behavioural Sciences
Leeds
LS2 9LN
United Kingdom
LS2 9LN
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Leeds Teaching Hospitals 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2009 | Yes | No |
