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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05251467
Recruitment Status : Recruiting
First Posted : February 22, 2022
Last Update Posted : February 22, 2022
Sponsor:
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
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

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.

Condition or disease Intervention/treatment
Cystic Fibrosis Digestive System Disease Genetic Disease Respiratory Tract Diseases Lung Diseases Pancreatic Disease Other: Focus group Other: Patient interview (n = approximately 10) Other: Questionnaire (n = 100) Device: Testing of the pilot PROM in a smartphone app (n = 100)

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Comprehensive Approach To Relief Of Digestive Symptoms In Cystic Fibrosis: CARDS-CF
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
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.
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 = 100)
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 = 100)
Daily testing of the pilot PROM in a smartphone app for 2 weeks




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Measurement of adherence to daily data capture of the PROM through a smartphone app over a 2 week period [ Time Frame: 2 years ]
    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.

  2. Attrition rate of participants [ Time Frame: 2 years ]
    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.

  3. Usability of the smartphone app [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with cystic fibrosis age 12 years and over
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05251467


Contacts
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Contact: Alan Smyth 0115 8230612 alan.smyth@nottingham.ac.uk
Contact: Rebecca Calthorpe rebecca.calthorpe@nottingham.ac.uk

Locations
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United Kingdom
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Alan Smyth       alan.smyth@nottingham.ac.uk   
Principal Investigator: Alan Smyth         
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
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
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Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT05251467    
Other Study ID Numbers: 21CS025
First Posted: February 22, 2022    Key Record Dates
Last Update Posted: February 22, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nottingham University Hospitals NHS Trust:
Patient reported outcome measure (PROM)
Gastrointestinal symptom burden
Symptom score
Gut
Abdomen
Additional relevant MeSH terms:
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Cystic Fibrosis
Digestive System Diseases
Gastrointestinal Diseases
Pancreatic Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Fibrosis
Pathologic Processes
Infant, Newborn, Diseases