Crohn's disease Inflammatory bowel disease ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age > 18 years, both genders • Anticipated availability for using multiple study devices over the period of 60 days, with appropriate breaks within this period. • Willingness to comply with the study protocol including the use of the digital devices and technologies. • Previous use of a smartphone for at least 3 months. • Ability to understand oral and/or written instructions in relation to the study protocol and Informed Consent in English or the native language of the country in residence with or without reasonable assistance. • Willingness to sign the IRB-approved Informed Consent Form (ICF) having had enough time and opportunity to think about his/her participation in the study. • Ability to walk independently, to sit and stand, socialise, communicate and capable of carrying out the various procedures proposed in the study, according to the opinion of the Investigator. • MoCA > 15 For IBD patients Established diagnosis of Ulcerative Colitis or Crohn's Disease based on the European Crohn's and Colitis Organisation - European Society of Gastrointestinal and Abdominal Radiology (ECCO-ESGAR) guideline [9]. • Diagnosis >=3 months before study entry
Exclusion criteria
Exclusion criteria: • Primary diagnosis of major sleep disorders (i.e., insomnia, obstructive sleep apnoea, central apnoea, narcolepsy and hypersomnia). • Primary diagnosis of chronic fatigue syndrome. • Presence of respiratory, cardiovascular, metabolic disorders or physical traumas that required hospitalization in the 3 months preceding the study enrollment or based on severity assessed by the PI as potentially interfering with the study execution. • Cognitive impairment resulting in an inability to walk or to understand the intention of the project. • Diagnosis of major psychiatric disorders according to DSM5 that can affect the execution of the study. • Recent suicidal attempt (active, interrupted, aborted) within the past five years or report suicidal ideation within the past 6 months. • Substance or ethanol abuse that may interfere with the patient's behavior, and sleep patterns. • Close affiliation with the investigational site (e.g. employee or student of the investigational site) • Diagnosis of cancer within the past 3 years, except basal or squamous skin cancer, which has been adequately treated. • Visual impairment, as judged by the investigator For IBD patients • • No established diagnosis of Ulcerative Colitis or Crohn's Disease based on the European Crohn's and Colitis Organisation - European Society of Gastrointestinal and Abdominal Radiology (ECCO-ESGAR) guideline [9]. • Diagnosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Digital measures with best correlations with the patient-reported measures of sleep disturbances and fatigue as well as the clinical outcome measures will be considered for further investigations in the subsequent larger study (part B, not included in this proposal). | — |
Countries
Netherlands
Outcome results
None listed