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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-28

Study Completion Date

2023-12-03

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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People with CF age 12 years and over

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.

Focus group

Intervention Type OTHER

Focus group to confirm PROM conceptual framework

Patient interview (n = approximately 10)

Intervention Type OTHER

Patient interviews to refine possible questions for the PROM

Questionnaire (n = 180)

Intervention Type OTHER

Online questionnaire to evaluate the proposed questions as part of PROM development in a larger population

Testing of the pilot PROM in a smartphone app (n = 150)

Intervention Type DEVICE

Daily testing of the pilot PROM in a smartphone app for 2 weeks

Interventions

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Focus group

Focus group to confirm PROM conceptual framework

Intervention Type OTHER

Patient interview (n = approximately 10)

Patient interviews to refine possible questions for the PROM

Intervention Type OTHER

Questionnaire (n = 180)

Online questionnaire to evaluate the proposed questions as part of PROM development in a larger population

Intervention Type OTHER

Testing of the pilot PROM in a smartphone app (n = 150)

Daily testing of the pilot PROM in a smartphone app for 2 weeks

Intervention Type DEVICE

Eligibility Criteria

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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