NCT05251467

A Comprehensive Approach To Relief Of Digestive Symptoms In Cystic Fibrosis: CARDS-CF

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 350 (actual)
• Sponsor: Nottingham University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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 over the last 24 hours. * Development of the initial conceptual framework underpinning the PROM and confirmed through a patient focus group. * Primary item (question) generation for the PROM which will then be refined through a series of interviews with people with CF. * Testing of the items through an online patient questionnaire for testing of frequency, burden and impact of the items. * Piloting testing of the draft PROM daily for 2 weeks via smartphone app. The recall period of the PROM will be gastrointestinal symptom burden over the previous 24 hours. Potential participant's will be identified through 6 UK CF care centres at Nottingham University Hospitals NHS Trust (paediatric and adult CF centres), Leeds Teaching Hospital NHS Trust, Manchester University NHS Foundation trust, Royal Brompton and Harefield NHS Foundation Trust and Kings College Hospital NHS Foundation Trust. In addition, recruitment for the survey and trialing the PROM on a smartphone app will also take place via social media and is therefore also open to people with CF from outside these CF centres.

Conditions

• Cystic Fibrosis
• Digestive System Disease
• Genetic Disease
• Respiratory Tract Diseases
• Lung Diseases
• Pancreatic Disease

Interventions

Type	Name	Description
OTHER	Focus group	Focus group to confirm PROM conceptual framework
OTHER	Patient interview (n = approximately 10)	Patient interviews to refine possible questions for the PROM
OTHER	Questionnaire (n = 180)	Online questionnaire to evaluate the proposed questions as part of PROM development in a larger population
DEVICE	Testing of the pilot PROM in a smartphone app (n = 150)	Daily testing of the pilot PROM in a smartphone app for 2 weeks

Timeline

• Start date: 2022-02-28
• Primary completion: 2023-12-03
• Completion: 2023-12-03
• First posted: 2022-02-22
• Last updated: 2024-07-22

Locations

1 site across 1 country: United Kingdom