Digital Signals of Stress in Crohn’s: Forecasting Symptom Transitions
Research type
Research Study
Full title
Digital Signals of Stress in Crohn’s: Forecasting Symptom Transitions
IRAS ID
269286
Contact name
Stephen Friend
Contact email
Sponsor organisation
4YouandMe
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Crohn’s disease is a relapsing and remitting condition, with each patient’s illness course being unique across a range of life events. In people with Crohn's disease there are relationships between external stressors, internal emotional states and psychological experiences, such as how one experiences illness. There is little information on how these individual factors contribute to Crohn’s disease progression, particularly between a patient’s clinic visits and how stress impacts symptom change and flare-ups. This present study is a multi-site prospective cohort study of patients with established Crohn’s disease. 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 200 patients will be enrolled and subsequently followed for 6-12 months. The aim of this project is to explore the feasibility of following stress using wearable devices to predict the risk of upcoming symptom changes. We will try to achieve this 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 active tasks such as a step test to measure fatigue. 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 and to couple this 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 eating, medication, and behavior including exposure to modifiable stress, to prevent negative clinical changes in their condition
Lay summary of study results: This preliminary investigation demonstrated statistically significant associations between nightly passive features from a smart ring (nighttime body temperature, overall sleep quality) and daily self-reported Crohn’s symptoms, including loose stools and abdominal pain as measured from the Patient Reported Outcome (PRO-2) Crohn’s Disease Outcome Measure. This finding suggests that passive measures from wearables could lend some insight into Crohn’s related symptoms. The data collected as part of this study posed challenges to yield further insights. These challenges included: 1) not enough follow-up time in patients to discern between healthy baseline periods and active Crohn’s disease symptoms; 2) the absence of a healthy control group to discern whether the wearable signals identified were reflective of Crohn’s disease activity, or that of individual variation; and 3) the study participants were actively managing their disease with medication, which creating challenges when attempting to identify full threshold Crohn’s disease flares. As this was a feasibility study, these lessons learned will be applied to future studies.
Study results will be published on the 4YouandMe website (https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.4youandme.org%2F&data=05%7C02%7CTracy.Hamrang%40hra.nhs.uk%7C058056718c2740951e7b08dcaa34f0ac%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638572391553074466%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=ToBorjkPdNIscxM5gsU8rKb7wgaXQS8Ic4s1gtgCxc8%3D&reserved=0)REC name
South Central - Hampshire A Research Ethics Committee
REC reference
19/SC/0556
Date of REC Opinion
15 Nov 2019
REC opinion
Favourable Opinion