Stress in Crohn's Disease

ID#: NCT04809194

Age: 18 - 65 years

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: February 22, 2021

End Date: March 01, 2023

Contact Information:
Stephen Friend, MD, PhD
Diane Mackenzie
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.

Inclusion Criteria:

- Diagnosis of Crohn's disease previously established by endoscopy, imaging, and/or histology

- Disease of the small bowel, large bowel, or both large and small bowel

- Needs to have at least one flare in the last 12 months while on current therapy

- Subjects may be on no treatment or may have concurrent treatment with 5-aminosalicylates, antibiotics, corticosteroids, thiopurines, methotrexate or biologic therapies, including infliximab, adalimumab, certolizumab pegol, vedolizumab, or ustekinumab

- Disease level, see stratified enrollment below

- Subjects must have a personal cell phone that is an iPhone SE or newer and be willing to upgrade to the most recent iOS operating system and use their phone for study. This includes a willingness to download and use the study applications and sync their phone with the necessary study devices.

Exclusion Criteria:

- Imminent indication for surgery, such as small bowel obstruction or abscess, or surgery in the past 4 weeks

- More than 100 cm of small bowel resected

- Dependence on chronic enteral supplementation or parenteral nutrition or fluids

- Ileostomy or Colostomy (some of the outcome measures do not apply as cannot count # bowel movements)

- History of asymptomatic Crohn's disease for the last 2 years

- Current use of investigational therapy

- Self-reported pregnancy or intent to become pregnant during the study period