Stress in Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      There is little information on how Crohn's disease progresses in between a patient's clinic
      visits and how stress impacts symptom change including flare-ups. The purpose of this
      research study is to see if digital tools like smartphones, and wearable devices are helpful
      in finding out new information that may explain fluctuation in symptoms. This study is a
      feasibility study that will try to identify biomarkers, collected through a smartphone app
      and wearable devices paired with clinical information collected during clinic visits to track
      participants' overall health for 6 to 12 months. The data collected will be used to identify
      and predict symptoms associated with Crohn's disease flare ups. The aim of this work is to
      inform knowledge of what triggers Crohn's disease worsening that might lead to advances in
      management.
    

Detailed description: 
      Crohn's disease is a relapsing and remitting condition, and each patient's course through
      their illness is unique across a range of life events. In people with Crohn's disease as with
      the general population, there are relationships between external stressors, internal
      emotional states and psychological experiences, such as how one experiences illness. The
      output of these aforementioned states has very rarely been studied in multiple body-systems,
      particularly in diseases of the gut which has many connections to the nervous system and uses
      many of the same chemical signalling pathways in the brain.

      Through close and continuous measurement of physiological, behavioral, and experiential
      information we will track participants over time by using smartwatches, smart rings, and
      smartphones on a cohort of over 200 patients with Crohn's disease in the United States and
      the United Kingdom to build a longitudinal model of each participant's disease. We will
      measure the patient's stress response using these tools to generate manual and passive data.
      The first is a customized application installed on the participant's own phone, which will
      track both passive sensor measurement and participant-generated active-task data.
      Additionally, a "smart" wristwatch and "smart" finger-ring wearable devices will be given to
      the participant for the duration of the study. The multimodal acquisition of periodic
      subjective data and continuous objective data collected by the two wearable devices will
      constitute an unprecedented comprehensive picture of each individual, their disease
      trajectory, and its connection to their stress response. All these signals will be anchored
      to clinic visits. As a result of following several hundred participants over the course of
      six to nine months, meaningful models of each individual's unique disease course as well as
      generalizable models that classify individuals into definable similar trajectories will be
      developed. This study will explore the feasibility and provide the direction for the studies
      needed to build out comprehensive individual forecasting tools for people with Crohn's
      disease to manage their own conditions.

      Ultimately, providing this early warning information from wearables directly to the
      individual will enable each patient to adapt aspects of their lifestyle, including exposure
      to modifiable stress, to prevent negative clinical changes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Crohn's disease attending clinics from the Icahn School of Medicine at Mount
        Sinai (n=140) and the Oxford Nuffield Department of Medicine (n=60)
      
Biospecimen description: 
      Stool sample to measure calprotectin using IBDoc Kits
    
Keywords: Digital health, Crohn's disease, Wearable technology