Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
11/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss J E Quinn

ORCID ID

Contact details

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18952395

Publication citations

  1. 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.

Additional files

Editorial Notes