UK observational study in patients with CD using C4T application
Research type
Research Study
Full title
A UK observational study to evaluate the impact of Care4Today Crohn’s, a smart system to facilitate the management of Crohn’s disease by patients and health care providers.
IRAS ID
268798
Contact name
Christian Selinger
Contact email
Sponsor organisation
Janssen-Cilag Limitd
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 3 months, 30 days
Research summary
Research Summary:
This is a UK, multi-centre, non-interventional study. This study will be conducted in eligible patients with Crohn’s Disease (CD) treated in routine clinical practice, and will describe the impact of a smart system called Care4Today (C4T) when introduced to patients alongside Standard of Care (SOC). Patients will be enrolled from between 3 and 5 NHS secondary care centres in the United Kingdom (UK).\n\nThe study is based on both retrospective and prospective collection of data, with a primary endpoint of the frequency of CD-related secondary care HCP contacts in the 6 months before vs after starting to use C4T. Retrospective data will be collected from medical notes. Prospective data will be collected from patient’s C4T app entries, completed Patient Reported Outcome (PRO) questionnaires and patients’ and Health Care Professionals’ (HCPs) completed online surveys. There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or visits will be required. \n\nThe population for this study is adult patients diagnosed with moderate to severe CD actively using C4T as part of their standard clinical care. The study will also include a sample of HCPs who are involved in the care of patients with CD using C4T at participating study centres. It is expected to recruit 100 patients and 16 HCPs in total.\n\nThe overall duration of the study is expected to be approximately 16 months, including 4 months for patient recruitment and approximately 12 months for data collection.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0381
Date of REC Opinion
9 Jan 2020
REC opinion
Further Information Favourable Opinion