Cystic Fibrosis Clinical Trial
— CARDS-CFOfficial title:
A Comprehensive Approach To Relief Of Digestive Symptoms In Cystic Fibrosis: CARDS-CF
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | September 30, 2023 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham |
Lead Sponsor | Collaborator |
---|---|
Nottingham University Hospitals NHS Trust | King's College Hospital NHS Trust, Manchester University NHS Foundation Trust, Medizinische Hochschule Brandenburg Theodor Fontane, Royal Brompton & Harefield NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 years | |
Secondary | 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. | 2 years | |
Secondary | 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. | 2 years | |
Secondary | 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. | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04696198 -
Thoracic Mobility in Cystic Fibrosis Care
|
N/A | |
Completed |
NCT00803205 -
Study of Ataluren (PTC124™) in Cystic Fibrosis
|
Phase 3 | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03601637 -
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
|
Phase 3 | |
Terminated |
NCT02769637 -
Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
|
||
Recruiting |
NCT06032273 -
Lung Transplant READY CF 2: CARING CF Ancillary RCT
|
N/A | |
Recruiting |
NCT06012084 -
The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis
|
N/A | |
Recruiting |
NCT06030206 -
Lung Transplant READY CF 2: A Multi-site RCT
|
N/A | |
Recruiting |
NCT05392855 -
Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)
|
N/A | |
Recruiting |
NCT06088485 -
The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
|
||
Recruiting |
NCT04056702 -
Impact of Triple Combination CFTR Therapy on Sinus Disease.
|
||
Recruiting |
NCT04039087 -
Sildenafil Exercise: Role of PDE5 Inhibition
|
Phase 2/Phase 3 | |
Completed |
NCT04058548 -
Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation
|
N/A | |
Completed |
NCT04038710 -
Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
|
||
Completed |
NCT03637504 -
Feasibility of a Mobile Medication Plan Application in CF Patient Care
|
N/A | |
Recruiting |
NCT03506061 -
Trikafta in Cystic Fibrosis Patients
|
Phase 2 | |
Completed |
NCT03566550 -
Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
|
||
Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
Completed |
NCT04568980 -
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
|
||
Recruiting |
NCT04010253 -
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
|
N/A |