MedTrace Logo

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

NCT02464267 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2017-10-27

No results posted yet for this study

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).

Conditions

Sponsors & Collaborators

  • University of Manchester

    collaborator OTHER

  • University of Zurich

    lead OTHER

Principal Investigators

  • Gabriela Schmid-Mohler · Centre of Clinical Nursing,

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02464267 on ClinicalTrials.gov