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

Academic Unit Psychiatry & Behavioural Sciences
15 Hyde Terrace
University of Leeds
Leeds
LS2 9LN
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectives1. 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) studiedNutritional, Metabolic, Endocrine: Cystic fibrosis
InterventionDatabase analysis; Questionnaire; Randomised controlled trial ( psychological intervention versus no psychological intervention); Before-after trial.
Intervention typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/03/2003
Completion date01/11/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/03/2003
Date of final enrolment01/11/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Academic Unit Psychiatry & Behavioural Sciences
Leeds
LS2 9LN
United Kingdom

Sponsor information

Department of Health
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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