Developing and Validating a Patient-reported Outcome Instrument to Monitor Symptom Management in Pulmonary Exacerbation in CF

Cystic Fibrosis Clinical Trial

Official title:

Developing and Validating a Patient-reported Outcome Instrument to Monitor Symptom Management in Pulmonary Exacerbation of Patients Living With Cystic Fibrosis - Item Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464267
• Other study ID #: KEK-ZK-Nr. 2014-0712
• Status: Completed
• Phase: N/A
• First received: April 22, 2015
• Last updated: October 26, 2017
• Start date: April 2015
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to develop a reliable and valid instrument to measure symptom management (experience and / or management strategies) during exacerbation episodes in CF patients. For the development a sequential exploratory two phase mixed-method study will be applied. In a first step, up to 25 CF patients will be interviewed: approximately 15 CF patients who experienced at least one episode of exacerbation in the past year and approximately CF 10 patients who are currently experiencing an exacerbation. The latter group will be interviewed up to 3 times during and after the antibiotic treatment. The instruments initial item list will be developed on basis of the interviews. Up to five health professionals will rate the items' relevance. In a further step, items' clarity and relevance will be assessed by cognitive debriefing interviews with no more than 10 patients. In the last step (part III), the instrument's preliminary construct and concurrent validity and reliability will be tested in a larger sample up to 150 patients experiencing exacerbation. Patients will be asked to complete the newly developed questionnaires and a set of other questionnaires at one time point. For part III, ethic approval will be asked at a later date (2015).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Part I A & II:

1. Patients with a confirmed diagnosis of cystic fibrosis

2. Age = 18

3. Experience of at least one exacerbation during the last year requiring antibiotic treatment (oral or intravenous)

Part I B:

1. Patients with a confirmed diagnosis of cystic fibrosis

2. Age = 18

3. Experience of an acute exacerbation requiring antibiotic treatment (oral or intravenous)

Exclusion Criteria:

Part I & II

1. Do not speak or understand German

2. Inability to verbally communicate

3. Cognitive impairment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	University of Manchester

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient experience of symptom management		Patients will be followed up for 4 weeks after start of antibiotic treatment