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

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

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).

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cystic Fibrosis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in patient experience of symptom management	Patients will be followed up for 4 weeks after start of antibiotic treatment

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: University of Manchester
• Investigators: Principal Investigator: Gabriela Schmid-Mohler, Centre of Clinical Nursing,

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: June 2, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: patient reported outcome instrument
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: KEK-ZK-Nr. 2014-0712