Cystic FibrosisCARDS-CFNCT05251467
A Comprehensive Approach To Relief Of Digestive Symptoms In Cystic Fibrosis: CARDS-CF
An observational study of Cystic Fibrosis and Digestive System Disease, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis, Digestive System Disease, Genetic Disease
- What is being tested?
- Focus group, Patient interview (n = approximately 10) and Questionnaire (n = 180)
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2022to 3 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with cystic fibrosis age 12 years and over
Who may be able to join
- 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
Who cannot join
- < 12 years age
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
About this study
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.
Read the 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
- Being tested
- Focus group, Patient interview (n = approximately 10), Questionnaire (n = 180), Testing of the pilot PROM in a smartphone app (n = 150)
- Keywords
- Patient reported outcome measure (PROM), Gastrointestinal symptom burden, Symptom score, Gut, Abdomen
- Medical subject headings
- Cystic Fibrosis, Digestive System Diseases, Genetic Diseases, Inborn, Respiratory Tract Diseases, Lung Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupOther
Focus group to confirm PROM conceptual framework
Patient interview (n = approximately 10)Other
Patient interviews to refine possible questions for the PROM
Questionnaire (n = 180)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)Device
Daily testing of the pilot PROM in a smartphone app for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start28 Feb 2022
- Primary completion3 Dec 2023
- Study completion3 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust, Manchester University NHS Foundation Trust, Royal Brompton & Harefield NHS Foundation Trust, King's College Hospital NHS Trust, Medizinische Hochschule Brandenburg Theodor Fontane
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251467
- Sponsor's protocol ID
- 21CS025
- Acronym
- CARDS-CF
- Status last verified
- Jul 2024
- First submitted
- 4 Feb 2022
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Approach To Relief Of Digestive Symptoms In Cystic Fibrosis: CARDS-CF
- ClinicalTrials.gov ID
- NCT05251467
- Acronym / sponsor ID
- CARDS-CF / 21CS025
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- The Leeds Teaching Hospitals NHS Trust, Manchester University NHS Foundation Trust, Royal Brompton & Harefield NHS Foundation Trust, King's College Hospital NHS Trust, Medizinische Hochschule Brandenburg Theodor Fontane
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 3 Dec 2023 (actual)
- Study completion
- 3 Dec 2023 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with CF age 12 years and over | – | 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)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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with cystic fibrosis age 12 years and over
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- < 12 years age
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus groupFocus group to confirm PROM conceptual framework | Other | People with CF age 12 years and over |
| Patient interview (n = approximately 10)Patient interviews to refine possible questions for the PROM | Other | People with CF age 12 years and over |
| Questionnaire (n = 180)Online questionnaire to evaluate the proposed questions as part of PROM development in a larger population | Other | People with CF age 12 years and over |
| Testing of the pilot PROM in a smartphone app (n = 150)Daily testing of the pilot PROM in a smartphone app for 2 weeks | Device | People with CF age 12 years and over |
Primary outcome
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.
Time frame: 2 years
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.
3 secondary outcomes
Measurement of adherence to daily data capture of the PROM through a smartphone app over a 2 week period
Time frame: 2 years
Attrition rate of participants
Time frame: 2 years
Usability of the smartphone app
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Digestive System Disease, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.