An observational study in Cystic Fibrosis, Digestive System Disease and Genetic Disease, sponsored by Nottingham University Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-07-22.
Sponsored by Nottingham University Hospitals NHS Trust · Observational
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.
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.
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 350 is above the median of 85 across 482 observational studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Nottingham University Hospitals NHS Trust is the lead sponsor of 104 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
People with cystic fibrosis age 12 years and over
Exclusion Criteria:
Participants will be identified through one of the 6 participating UK CF centres as well as recruiting via social media. Participants outside the 6 listed CF centres as well as outside the UK are also eligible.
Other: Focus group · Other: Patient interview (n = approximately 10) · Other: Questionnaire (n = 180) · Device: Testing of the pilot PROM in a smartphone app (n = 150)
Focus group to confirm PROM conceptual framework
Patient interviews to refine possible questions for the PROM
Online questionnaire to evaluate the proposed questions as part of PROM development in a larger population
Daily testing of the pilot PROM in a smartphone app for 2 weeks
To develop a new patient reported outcome measure (PROM) which will measure the daily gastrointestinal symptom burden for people with CF, with a recall period of 24 hours.
Development of a new PROM following FDA guidance which will measure the daily impact and burden of gastrointestinal symptoms for people with CF. The recall period will be the previous 24 hours. The name of the PROM will be decided as part of the development process. Question development will be iterative. Floor and ceiling effects for each of the questions will be assessed. The CFAbd score will be used to assess construct validity of the newly developed PROM. This will be completed alongside the PROM on days 1 and day 14.
Time frame: 2 years
Measurement of adherence to daily data capture of the PROM through a smartphone app over a 2 week period
Adherence data - Percentage of completed PROM days over the 14 day period. Percentage of completed CFabd scores on days 1 and 14. This data will be collated through the research portal feedback facility in the app.
Time frame: 2 years
Attrition rate of participants
Attrition rate over the 2 weeks, define as people completing the app for two weeks (at least 10 out of 14 days) as a percentage of those initially who gave consent to take part and use the app.
Time frame: 2 years
Usability of the smartphone app
Usability of the app - participant feedback via the app on days 7 and 14 to include questions of ease of data entry on the app, whether they experience any technical issues with the app and whether questions are meaningful to participants. These questions will be developed as part of the PROM development process.
Time frame: 2 years
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Nottingham University Hospitals NHS Trust