ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02464267
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
University of Zurich

Brief 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).

Condition or disease
Cystic Fibrosis

Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Other
Time Perspective: Other
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
Study Start Date : April 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in patient experience of symptom management [ Time Frame: Patients will be followed up for 4 weeks after start of antibiotic treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cystic Fibrosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464267


Locations
Switzerland
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
University of Manchester
Investigators
Principal Investigator: Gabriela Schmid-Mohler Centre of Clinical Nursing,

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02464267     History of Changes
Other Study ID Numbers: KEK-ZK-Nr. 2014-0712
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by University of Zurich:
patient reported outcome instrument

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases