Clinical trial NCT05251467: A Comprehensive Approach To Relief Of Digestive Symptoms In Cystic Fibrosis: CARDS-CF
Official title: A Comprehensive Approach To Relief Of Digestive Symptoms In Cystic Fibrosis: CARDS-CF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Digestive System Disease
Genetic Disease
Respiratory Tract Diseases
Lung Diseases
Pancreatic Disease
Keywords: Patient reported outcome measure (PROM)
Gastrointestinal symptom burden
Symptom score
Gut
Abdomen
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: The Leeds Teaching Hospitals NHS Trust
name: Manchester University NHS Foundation Trust
name: Royal Brompton & Harefield NHS Foundation Trust
name: King's College Hospital NHS Trust
name: Medizinische Hochschule Brandenburg Theodor Fontane
First posted: 2022-02-22
Enrollment: 350
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with cystic fibrosis age 12 years and over

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* \< 12 years age
* Unable to give informed consent

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Measurement of adherence to daily data capture of the PROM through a smartphone app over a 2 week period
timeFrame: 2 years
measure: Attrition rate of participants
timeFrame: 2 years
measure: Usability of the smartphone app
timeFrame: 2 years
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
References: