Crohn DiseaseNCT04809194
Stress in Crohn's Disease
An observational study of Crohn Disease, run by 4YouandMe at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease
- How many people
- 195 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2019to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Nuffield Department of Population Health of Oxford University
Oxford, OX3 7LF
About this study
Official title: Digital Signals of Stress in Crohn's: Forecasting Symptom Transitions
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.
Read the 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 population, there are relationships between external stressors, internal emotional states and psychological experiences, such as how one experiences illness. The output of these aforementioned states has very rarely been studied in multiple body-systems, particularly in diseases of the gut which has many connections to the nervous system and uses many of the same chemical signalling pathways in the brain.
Through close and continuous measurement of physiological, behavioral, and experiential information we will track participants over time by using smartwatches, smart rings, and smartphones on a cohort of over 200 patients with Crohn's disease in the United States and the United Kingdom to build a longitudinal model of each participant's disease. We will measure the patient's stress response using these tools to generate manual and passive data. The first is a customized application installed on the participant's own phone, which will track both passive sensor measurement and participant-generated active-task data. Additionally, a "smart" wristwatch and "smart" finger-ring wearable devices will be given to the participant for the duration of the study. The multimodal acquisition of periodic subjective data and continuous objective data collected by the two wearable devices will constitute an unprecedented comprehensive picture of each individual, their disease trajectory, and its connection to their stress response. All these signals will be anchored to clinic visits. As a result of following several hundred participants over the course of six to nine months, meaningful models of each individual's unique disease course as well as generalizable models that classify individuals into definable similar trajectories will be developed. This study will explore the feasibility and provide the direction for the studies needed to build out comprehensive individual forecasting tools for people with Crohn's disease to manage their own conditions.
Ultimately, providing this early warning information from wearables directly to the individual will enable each patient to adapt aspects of their lifestyle, including exposure to modifiable stress, to prevent negative clinical changes.
- Conditions
- Crohn Disease
- Keywords
- Digital health, Crohn's disease, Wearable technology
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Retention
Proportion of participants completing the study
Measured: 6-12 months
Daily survey/task adherence
Average completion of daily app-based surveys/tasks
Measured: 6-12 months
Oura adherence
Average usage of the Oura smartring during study follow-up (minutes of daily device wear)
Measured: 6-12 months
Empatica adherence
Average usage of the Empatica smartwatch during study follow-up (minutes of device on skin detection)
Measured: 6-12 months
Bodyport adherence
Average usage of the Bodyport smartscale during study follow-up (number of weigh-ins)
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start1 Sep 2019
- Primary completion30 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4YouandMe
- Sponsor type
- University, hospital or other
- Collaborators
- Evidation Health, Vector Institute of Artificial Intelligence, Icahn School of Medicine at Mount Sinai, Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Stephen Friend, MD, PhD, Principal investigator, 4YouandMe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809194
- Sponsor's protocol ID
- 4UCROHNS01
- Status last verified
- Jan 2023
- First submitted
- 19 Mar 2021
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Subsets of the coded study data will be made accessible to researchers according to tiered permission: Internal Researchers (4YouandMe, Vector Institute, Evidation Health) will have access to all coded data. Collaboration Partners (Empatica, Bodyport, and Oura) will have access to a subset of coded data streams quarterly, with the exclusion of the video diary and any relative location data. Each partner will additionally have the data collected by their respective system. Clinical Collaborators will have access to the complete coded data set (with the exclusion of the video diary and any relative location data) at study end. De-identified data produced from this project will be shared broadly with qualified researchers through Sage Bionetworks Synapse. Only data from consenting participants will be shared through Sage Bionetworks Synapse and this will not include video diary data, relative location data or social media data.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Signals of Stress in Crohn's: Forecasting Symptom Transitions
- ClinicalTrials.gov ID
- NCT04809194
- Acronym / sponsor ID
- 4UCROHNS01
- Conditions
- Crohn Disease
- Keywords
- Digital health, Crohn's disease, Wearable technology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- 4YouandMeUniversity, hospital or other
- Collaborators
- Evidation Health, Vector Institute of Artificial Intelligence, Icahn School of Medicine at Mount Sinai, Oxford University Hospitals NHS Trust
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 population, there are relationships between external stressors, internal emotional states and psychological experiences, such as how one experiences illness. The output of these aforementioned states has very rarely been studied in multiple body-systems, particularly in diseases of the gut which has many connections to the nervous system and uses many of the same chemical signalling pathways in the brain.
Through close and continuous measurement of physiological, behavioral, and experiential information we will track participants over time by using smartwatches, smart rings, and smartphones on a cohort of over 200 patients with Crohn's disease in the United States and the United Kingdom to build a longitudinal model of each participant's disease. We will measure the patient's stress response using these tools to generate manual and passive data. The first is a customized application installed on the participant's own phone, which will track both passive sensor measurement and participant-generated active-task data. Additionally, a "smart" wristwatch and "smart" finger-ring wearable devices will be given to the participant for the duration of the study. The multimodal acquisition of periodic subjective data and continuous objective data collected by the two wearable devices will constitute an unprecedented comprehensive picture of each individual, their disease trajectory, and its connection to their stress response. All these signals will be anchored to clinic visits. As a result of following several hundred participants over the course of six to nine months, meaningful models of each individual's unique disease course as well as generalizable models that classify individuals into definable similar trajectories will be developed. This study will explore the feasibility and provide the direction for the studies needed to build out comprehensive individual forecasting tools for people with Crohn's disease to manage their own conditions.
Ultimately, providing this early warning information from wearables directly to the individual will enable each patient to adapt aspects of their lifestyle, including exposure to modifiable stress, to prevent negative clinical changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study Retention
Time frame: 6-12 months
Proportion of participants completing the study
Daily survey/task adherence
Time frame: 6-12 months
Average completion of daily app-based surveys/tasks
Oura adherence
Time frame: 6-12 months
Average usage of the Oura smartring during study follow-up (minutes of daily device wear)
Empatica adherence
Time frame: 6-12 months
Average usage of the Empatica smartwatch during study follow-up (minutes of device on skin detection)
Bodyport adherence
Time frame: 6-12 months
Average usage of the Bodyport smartscale during study follow-up (number of weigh-ins)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: Yes. Subsets of the coded study data will be made accessible to researchers according to tiered permission: Internal Researchers (4YouandMe, Vector Institute, Evidation Health) will have access to all coded data. Collaboration Partners (Empatica, Bodyport, and Oura) will have access to a subset of coded data streams quarterly, with the exclusion of the video diary and any relative location data. Each partner will additionally have the data collected by their respective system. Clinical Collaborators will have access to the complete coded data set (with the exclusion of the video diary and any relative location data) at study end. De-identified data produced from this project will be shared broadly with qualified researchers through Sage Bionetworks Synapse. Only data from consenting participants will be shared through Sage Bionetworks Synapse and this will not include video diary data, relative location data or social media data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Friend, MD, PhD principal investigator
4YouandMe
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by 4YouandMe at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Retention (time frame: 6-12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.