Status:
COMPLETED
A Comprehensive Approach To Relief Of Digestive Symptoms In Cystic Fibrosis: CARDS-CF
Lead Sponsor:
Nottingham University Hospitals NHS Trust
Collaborating Sponsors:
The Leeds Teaching Hospitals NHS Trust
Manchester University NHS Foundation Trust
Conditions:
Cystic Fibrosis
Digestive System Disease
Eligibility:
All Genders
12+ years
Brief Summary
Development of a new patient reported outcome measure (PROM) that will measure the daily burden of gastrointestinal symptoms over the previous 24 hour period for people with cystic fibrosis.
Detailed Description
Development of a Patient Reported Outcome Measure (PROM) in line with FDA guidance. The PROM is intended for daily use to measure the symptom burden of gastrointestinal symptoms for people with CF ove...
Eligibility Criteria
Inclusion
- People with cystic fibrosis age 12 years and over
- Confirmed diagnosis of cystic fibrosis based on genotype or sweat chloride testing
- Capacity to consent, or to understand the requirements of the study where parental consent is required
Exclusion
- \< 12 years age
- Unable to give informed consent
Key Trial Info
Start Date :
February 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 3 2023
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT05251467
Start Date
February 28 2022
End Date
December 3 2023
Last Update
July 22 2024
Active Locations (1)
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1
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH