Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436130480
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Cystic fibrosis
Intervention
Database analysis; Questionnaire; Randomised controlled trial ( psychological intervention versus no psychological intervention); Before-after trial.
Intervention type
Other
Phase
Not Specified
Drug names
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 trial start date
01/03/2003
Overall trial end date
01/11/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2003
Recruitment end date
01/11/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Unit Psychiatry & Behavioural Sciences
Leeds
LS2 9LN
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
Government
Funder name
Leeds Teaching Hospitals 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
Basic results (scientific)
Publication list
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18952395
Publication citations
-
Results
Latchford G, Duff A, Quinn J, Conway S, Conner M, Adherence to nebulised antibiotics in cystic fibrosis., Patient Educ Couns, 2009, 75, 1, 141-144, doi: 10.1016/j.pec.2008.08.027.