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Stress in Crohn’s
Goal/Objective:
The Stress in Crohn’s study was designed to explore the feasibility of following stress using wearable devices to predict the risk of upcoming symptom changes. Day to day acute changes, as well as the longer-term progression of Crohn’s disease are known to be somehow affected by stress, but the details of this relationship is poorly understood. The Goal of this study is to empower those with Crohn’s disease by enabling them to monitor their own stress responses and early warning signs of impending illness worsening in between clinic visits and to provide the means to navigate their lives in ways that mitigate the consequences of stress on their disease.
Description of the study:
The Stress in Crohn’s study is a Helmsley Trust funded multi-site prospective up to 200 participant cohort study of patients with established Crohn’s disease for 6 to 9 months. For this project, 4YouandMe has partnered with clinicians at Oxford University in the United Kingdom and Mount Sinai School of Medicine in the United States comprising the two clinical sites where patients will be enrolled digitally starting in February 2021.
This study will follow stress through close and continuous physiological and behavioral measurements using a study companion app installed on the participant's own phone, which will track both passive sensor measures and cognitive active tasks. Additionally, a smart wristwatch, a smart scale, and smart ring will be given to participants. These devices allow us to collect real time signals of stress almost continually. We plan to couple these high dimensional data to patient reported symptoms of their Crohn’s disease and levels of stress. Our goal through this work is to eventually help people with Crohn’s disease manage their own symptoms between clinician visits. Clues identified from this clinical study could provide an “early detection system” to enable each patient to adapt aspects of their behavior including exposure to modifiable stress, to prevent negative clinical changes in their condition.
Size and Timing:
Up to 200 participants over the course of six months to a year
Funder:
Helmsley Trust
Clinical Partner(s):
Mount Sinai School of Medicine and Oxford University
Coalition and Collaboration Partners:
Bodyport, Cambridge Cognition, Empatica, Evidation, Healthmode, and Vector Institute.