Status:
COMPLETED
Stress in Crohn's Disease
Lead Sponsor:
4YouandMe
Collaborating Sponsors:
Evidation Health
Vector Institute of Artificial Intelligence
Conditions:
Crohn Disease
Eligibility:
All Genders
18-65 years
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 s...
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 popu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT04809194
Start Date
September 1 2019
End Date
June 30 2022
Last Update
January 5 2023
Active Locations (2)
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1
Mount Sinai
New York, New York, United States, 10016
2
Nuffield Department of Population Health of Oxford University
Oxford, United Kingdom, OX3 7LF