Stress in Crohn's Disease

NCT04809194 | Completed

• 1 other identifier: 4UCROHNS01
• Study Type: observational
• Target: 195
• Locations: 2 countries
• Sites: 2

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.

Conditions

Crohn Disease

Keywords

Digital health, Crohn's disease, Wearable technology

Outcome Measures

Primary Outcomes (5)

• Study Retention

  Proportion of participants completing the study

  6-12 months

• Daily survey/task adherence

  Average completion of daily app-based surveys/tasks

  6-12 months

• Oura adherence

  Average usage of the Oura smartring during study follow-up (minutes of daily device wear)

  6-12 months

• Empatica adherence

  Average usage of the Empatica smartwatch during study follow-up (minutes of device on skin detection)

  6-12 months

• Bodyport adherence

  Average usage of the Bodyport smartscale during study follow-up (number of weigh-ins)

  6-12 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Crohn's disease attending clinics from the Icahn School of Medicine at Mount Sinai (n=140) and the Oxford Nuffield Department of Medicine (n=60)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• 4YouandMe: lead
• Evidation Health: collaborator
• Vector Institute of Artificial Intelligence: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (2)

Mount Sinai

New York, New York, 10016, United States

Location

Nuffield Department of Population Health of Oxford University

Oxford, OX3 7LF, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool sample to measure calprotectin using IBDoc Kits

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Stephen Friend, MD, PhD

  4YouandMe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 22, 2021
• Study Start: September 1, 2019
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Internal researchers will have access to all coded data during the full duration of the study. Consented participants' coded data will be available in the Synapse at Sage Bionetworks for selected researchers to access indefinitely, one year after study completion.
• Access Criteria: Qualified Researcher

Locations

US (1); GB (1)