Clinical trial NCT04333810: Remote Physiologic Monitoring to Detect Inflammatory Bowel Disease (IBD) Flares: A Feasibility Study
Official title: Remote Physiologic Monitoring to Detect Inflammatory Bowel Disease (IBD) Flares: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Keywords: Remote monitoring
Heart rate variability
Whoop strap 3.0
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inflammatory Bowel Disease flares
timeFrame: 6 months
measure: Change in Sleep (hours per night)
timeFrame: 6 months, change measured every 2 weeks
measure: Change in Heart Rate Variability (HRV)
timeFrame: 6 months, change measured every 2 weeks
measure: Change in Resting Heart Rate (RHR)
timeFrame: 6 months, change measured every 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Andrew Tinsley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carson HJ, Dudley MH, Knight LD, Lingamfelter D. Psychosocial complications of Crohn's disease and cause of death. J Forensic Sci. 2014 Mar;59(2):568-70. doi: 10.1111/1556-4029.12314.
citation: Jones JL, Nguyen GC, Benchimol EI, Bernstein CN, Bitton A, Kaplan GG, Murthy SK, Lee K, Cooke-Lauder J, Otley AR. The Impact of Inflammatory Bowel Disease in Canada 2018: Quality of Life. J Can Assoc Gastroenterol. 2019 Feb;2(Suppl 1):S42-S48. doi: 10.1093/jcag/gwy048. Epub 2018 Nov 2.
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