Remote Physiologic Monitoring to Detect Inflammatory Bowel Disease (IBD) Flares: A Feasibility Study

September 20, 2023 updated by: Andrew Tinsley, Milton S. Hershey Medical Center
Inflammatory bowel disease (IBD) has become a more prominent disease in the US population, with more than 3 million adults in the US affected. To manage this disease effectively, physicians tend to need to have a multidisciplinary approach as there are many psychosocial implications of chronic gastrointestinal illnesses like Crohn's and Ulcerative Colitis. Recent literature has supported the desire for telemedicine and remote physiologic monitoring for such patients to allow the patient to be more active in their treatments and make physicians more aware of what their bodies are doing from a physiologic perspective. Whoop is a new device founded in 2011 that has grown in popularity for its ability to accurately measure sleep patterns, resting heart rate, and heart rate variability (HRV) amongst other various physiologic measurements. Newer literature supports that depressed heart rate variability can correlate to disease flares such as heart failure exacerbations. The study investigators proposed that using remote physiologic monitoring in the IBD population along with their symptoms can help predict disease severity and potentially lead to earlier interventions if correlations are accurate. It can also spark interest in the younger generation for remote physiologic monitoring and telemedicine, which is believed to be beneficial in patients with chronic illnesses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of inflammatory bowel disease continues to rise in the United States, with an estimated 3 million adults carrying this diagnosis in 2015. With inflammatory bowel disease (IBD) comes significant psychosocial implications [Carson, 2013].These patients often feel alone and isolated due to their underlying disease burden. Literature has supported that subjectively; these patients often feel like they are isolated and also have a poor quality of life [Jones, 2019]. One of the biggest factors that has been evaluated in determining quality of life has been sleep. With the aid of the Pittsburgh Quality Sleep Index (PSQI), there has been proof that patients with active disease have poor sleep quality compared to their counterparts with IBD patients in general having worse sleep cycles as compared to healthy individuals [Sobolewska-Wlodarczyk, 2018; Ananthakrishnan, 2013]. It is hypothesized that disruption of the circadian system increases the release of inflammatory cytokines and immune activation, playing a role in chronic inflammatory diseases [Swanson, 2011]. Despite these correlations with sleep via subjective measures, no great objective data has been collected on this patient population.

Another physiologic measurement that has been used for prediction and management of chronic diseases is heart rate variability (HRV). One highly investigated disease was heart failure [Jimenez-Morgan, 2017; Goessl, 2017, Shaffer, 2017; Bullinga; 2005; Tsuji, 1996]. The metric of HRV was used to predict mortality in heart failure with reduced ejection fraction and new cardiac events for which depressed HRV was predictive of more disease burden [Liu, 2014]. Other chronic diseases have yet been explored in regard to quantifiable physiologic measures.

There has been a push amongst all providers to search for a better way to connect with their patients. Multiple mobile applications have been explored, especially in the IBD community [Riaz, 2016]. These individuals are wanting to be more involved in their care and be kept in the loop. The investigators propose utilizing the Whoop Strap 3.0 to evaluate a number of physiologic metrics as well as sleep measures. Telemonitoring is currently being explored in this population, but there is a desire for something more that can quantify data: remote physiologic monitoring. This device can also help with shared decision making and have the patient directly involved in his or her care [Baars, 2010]. A recent study validated the Whoop device for sleep tracking and compared it to polysomnography, nearly identical in their results [Berryhill, 2020]. The device can also promote good healthy lifestyles with exercise, which is known to beneficial in this population [Engels, 2017].

For this project, the investigators propose to investigate disease activity in accordance to physiologic and lifestyle measures utilizing the Whoop strap 3.0. This device and mobile application allow the patient to input everyday symptoms and overall activity which can allow us to correlate some subjective symptoms of potential disease flare with physiologic measurements. There is no published literature looking at the IBD population and has only been investigated in the cardiology realm, which has shown some positive correlation with chronic disease.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Inflammatory Bowel Disease (IBD) patients at Penn State Milton S. Hershey Medical Center with either active disease or inactive disease (remission) will be enrolled in this study according to the inclusion and exclusion criteria below.

Description

Inclusion Criteria:

  • IBD patients at Penn State Milton S. Hershey Medical Center
  • Age greater than 18

Exclusion Criteria:

  • Inability to wear Whoop Strap 3.0 for 24 hours per day for 6 months
  • Subjects who are pregnant
  • Subjects who are on anti-arrhythmic medications
  • Subjects who are prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active IBD patients
Patients with active IBD, based on colonoscopic evaluation and biopsy results.
Device: Whoop strap 3.0
WHOOP strap 3.0, a photodiode-based device that tracks sleep duration, resting heart rate, heart rate variability, activity (calories).
IBD patients in remission
IBD patients in remission, with no recently colonoscopic evidence of disease, and only on maintenance therapy.
Device: Whoop strap 3.0
WHOOP strap 3.0, a photodiode-based device that tracks sleep duration, resting heart rate, heart rate variability, activity (calories).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory Bowel Disease flares
Time Frame: 6 months
Inflammatory Bowel Disease flares will be assessed by symptomatology and verified by colonoscopic biopsies to confirm active disease, reemergence of disease, or new disease.
6 months
Change in Sleep (hours per night)
Time Frame: 6 months, change measured every 2 weeks
Sleep will be objectively measured nightly using the wearable Whoop strap 3.0, and averages will be compared every 2 weeks over the duration of the study.
6 months, change measured every 2 weeks
Change in Heart Rate Variability (HRV)
Time Frame: 6 months, change measured every 2 weeks
Heart Rate Variability will be objectively measured nightly using the wearable Whoop strap 3.0. Average two-week values will be assessed for change every 2 weeks over the duration of the study.
6 months, change measured every 2 weeks
Change in Resting Heart Rate (RHR)
Time Frame: 6 months, change measured every 2 weeks
Resting Heart Rate will be objectively measured nightly using the wearable Whoop strap 3.0. Average two-week values will be assessed for change every 2 weeks over the duration of the study.
6 months, change measured every 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Andrew Tinsley, MD, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY14888

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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