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

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• Manchester University NHS Foundation Trust

  collaborator OTHER_GOV

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• King's College Hospital NHS Trust

  collaborator OTHER

• Medizinische Hochschule Brandenburg Theodor Fontane

  collaborator OTHER

• Nottingham University Hospitals NHS Trust

  lead OTHER

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-28

Primary Completion

2023-12-03

Completion

2023-12-03

Countries

• United Kingdom

Study Locations