Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT04809194
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2021-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress in Crohn's Disease
Sponsor:
4YouandMe
Organization:
Study Overview
Official Title:
Digital Signals of Stress in Crohn's: Forecasting Symptom Transitions
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: