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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02464267

Enrollment

Registered

2015-06-08

Start date

2015-04-30

Completion date

2017-09-30

Last updated

2017-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

patient reported outcome instrument

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).

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Switzerland

Outcome results