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

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ClinicalTrials.gov Identifier: NCT04333810
Recruitment Status : Not yet recruiting
First Posted : April 3, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Andrew Tinsley, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Device: Whoop strap 3.0

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.

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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remote Physiologic Monitoring to Detect Inflammatory Bowel Disease (IBD) Flares: A Feasibility Study
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : March 30, 2021

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).




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333810


Contacts
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Contact: Kara DiJoseph, DO 7175315160 kdijoseph@pennstatehealth.psu.edu
Contact: Alexander Hajduczok, MD 7175315160 ahajduczok@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Contact: Alexander Hajduczok, MD       ahajduczok@pennstatehealth.psu.edu   
Principal Investigator: Kara DiJoseph, DO         
Sub-Investigator: Alexander Hajduczok, MD         
Sub-Investigator: Michelle Rosario, MD         
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Andrew Tinsley, MD Milton S. Hershey Medical Center
Publications:

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Responsible Party: Andrew Tinsley, Associate Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04333810    
Other Study ID Numbers: STUDY14888
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew Tinsley, Milton S. Hershey Medical Center:
Remote monitoring
Heart rate variability
Whoop strap 3.0
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis