Inflammatory Bowel DiseasesNCT04333810
Remote Physiologic Monitoring to Detect Inflammatory Bowel Disease (IBD) Flares: A Feasibility Study
An observational study of Inflammatory Bowel Diseases, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Whoop strap 3.0
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 31 Jul 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- IBD patients at Penn State Milton S. Hershey Medical Center
- Age greater than 18
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Whoop strap 3.0
- Keywords
- Remote monitoring, Heart rate variability, Whoop strap 3.0
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whoop strap 3.0Device
WHOOP strap 3.0, a photodiode-based device that tracks sleep duration, resting heart rate, heart rate variability, activity (calories).
| Study group | Role | What they receive |
|---|---|---|
| Active IBD patients | Patients with active IBD, based on colonoscopic evaluation and biopsy results. Receives: Device: Whoop strap 3.0 | |
| IBD patients in remission | IBD patients in remission, with no recently colonoscopic evidence of disease, and only on maintenance therapy. Receives: Device: Whoop strap 3.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Bowel Disease flares
Inflammatory Bowel Disease flares will be assessed by symptomatology and verified by colonoscopic biopsies to confirm active disease, reemergence of disease, or new disease.
Measured: 6 months
Change in Sleep (hours per night)
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.
Measured: 6 months, change measured every 2 weeks
Change in Heart Rate Variability (HRV)
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.
Measured: 6 months, change measured every 2 weeks
Change in Resting Heart Rate (RHR)
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.
Measured: 6 months, change measured every 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Oct 2020
- Primary completion31 Jul 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Tinsley, Milton S. Hershey Medical Center
- Investigators
- Andrew Tinsley, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333810
- Sponsor's protocol ID
- STUDY14888
- Status last verified
- Sep 2023
- First submitted
- 1 Apr 2020
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24749148Jones 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.
PubMed 31294384Sobolewska-Wlodarczyk A, Wlodarczyk M, Banasik J, Gasiorowska A, Wisniewska-Jarosinska M, Fichna J. Sleep disturbance and disease activity in adult patients with inflammatory bowel diseases. J Physiol Pharmacol. 2018 Jun;69(3). doi: 10.26402/jpp.2018.3.09. Epub 2018 Sep 28.
PubMed 30279306Ananthakrishnan AN, Long MD, Martin CF, Sandler RS, Kappelman MD. Sleep disturbance and risk of active disease in patients with Crohn's disease and ulcerative colitis. Clin Gastroenterol Hepatol. 2013 Aug;11(8):965-71. doi: 10.1016/j.cgh.2013.01.021. Epub 2013 Feb 1.
PubMed 23376797Swanson GR, Gorenz A, Shaikh M, Desai V, Forsyth C, Fogg L, Burgess HJ, Keshavarzian A. Decreased melatonin secretion is associated with increased intestinal permeability and marker of endotoxemia in alcoholics. Am J Physiol Gastrointest Liver Physiol. 2015 Jun 15;308(12):G1004-11. doi: 10.1152/ajpgi.00002.2015. Epub 2015 Apr 23.
PubMed 25907689Jimenez Morgan S, Molina Mora JA. Effect of Heart Rate Variability Biofeedback on Sport Performance, a Systematic Review. Appl Psychophysiol Biofeedback. 2017 Sep;42(3):235-245. doi: 10.1007/s10484-017-9364-2.
PubMed 28573597Goessl VC, Curtiss JE, Hofmann SG. The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychol Med. 2017 Nov;47(15):2578-2586. doi: 10.1017/S0033291717001003. Epub 2017 May 8.
PubMed 28478782Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
PubMed 29034226Bullinga JR, Alharethi R, Schram MS, Bristow MR, Gilbert EM. Changes in heart rate variability are correlated to hemodynamic improvement with chronic CARVEDILOL therapy in heart failure. J Card Fail. 2005 Dec;11(9):693-9. doi: 10.1016/j.cardfail.2005.06.435.
PubMed 16360965Tsuji H, Larson MG, Venditti FJ Jr, Manders ES, Evans JC, Feldman CL, Levy D. Impact of reduced heart rate variability on risk for cardiac events. The Framingham Heart Study. Circulation. 1996 Dec 1;94(11):2850-5. doi: 10.1161/01.cir.94.11.2850.
PubMed 8941112Liu G, Wang L, Wang Q, Zhou G, Wang Y, Jiang Q. A new approach to detect congestive heart failure using short-term heart rate variability measures. PLoS One. 2014 Apr 18;9(4):e93399. doi: 10.1371/journal.pone.0093399. eCollection 2014.
PubMed 24747432Riaz MS, Atreja A. Personalized Technologies in Chronic Gastrointestinal Disorders: Self-monitoring and Remote Sensor Technologies. Clin Gastroenterol Hepatol. 2016 Dec;14(12):1697-1705. doi: 10.1016/j.cgh.2016.05.009. Epub 2016 May 14.
PubMed 27189911Baars JE, Markus T, Kuipers EJ, van der Woude CJ. Patients' preferences regarding shared decision-making in the treatment of inflammatory bowel disease: results from a patient-empowerment study. Digestion. 2010;81(2):113-9. doi: 10.1159/000253862. Epub 2010 Jan 9.
PubMed 20093836Berryhill S, Morton CJ, Dean A, Berryhill A, Provencio-Dean N, Patel SI, Estep L, Combs D, Mashaqi S, Gerald LB, Krishnan JA, Parthasarathy S. Effect of wearables on sleep in healthy individuals: a randomized crossover trial and validation study. J Clin Sleep Med. 2020 May 15;16(5):775-783. doi: 10.5664/jcsm.8356. Epub 2020 Feb 11.
PubMed 32043961Engels M, Cross RK, Long MD. Exercise in patients with inflammatory bowel diseases: current perspectives. Clin Exp Gastroenterol. 2017 Dec 22;11:1-11. doi: 10.2147/CEG.S120816. eCollection 2018.
PubMed 29317842
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Physiologic Monitoring to Detect Inflammatory Bowel Disease (IBD) Flares: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04333810
- Acronym / sponsor ID
- STUDY14888
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Remote monitoring, Heart rate variability, Whoop strap 3.0
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 3 Apr 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active IBD patients | – | Device: Whoop strap 3.0Patients with active IBD, based on colonoscopic evaluation and biopsy results. |
| IBD patients in remission | – | Device: Whoop strap 3.0IBD patients in remission, with no recently colonoscopic evidence of disease, and only on maintenance therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- IBD patients at Penn State Milton S. Hershey Medical Center
- Age greater than 18
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whoop strap 3.0WHOOP strap 3.0, a photodiode-based device that tracks sleep duration, resting heart rate, heart rate variability, activity (calories). | Device | Active IBD patients, IBD patients in remission |
Primary outcome
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.
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.
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.
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.
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 21 Sep 2023.
- Background: PubMed 24749148Carson 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.
- Background: PubMed 31294384Jones 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.
- Background: PubMed 30279306Sobolewska-Wlodarczyk A, Wlodarczyk M, Banasik J, Gasiorowska A, Wisniewska-Jarosinska M, Fichna J. Sleep disturbance and disease activity in adult patients with inflammatory bowel diseases. J Physiol Pharmacol. 2018 Jun;69(3). doi: 10.26402/jpp.2018.3.09. Epub 2018 Sep 28.
- Background: PubMed 23376797Ananthakrishnan AN, Long MD, Martin CF, Sandler RS, Kappelman MD. Sleep disturbance and risk of active disease in patients with Crohn's disease and ulcerative colitis. Clin Gastroenterol Hepatol. 2013 Aug;11(8):965-71. doi: 10.1016/j.cgh.2013.01.021. Epub 2013 Feb 1.
- Background: PubMed 25907689Swanson GR, Gorenz A, Shaikh M, Desai V, Forsyth C, Fogg L, Burgess HJ, Keshavarzian A. Decreased melatonin secretion is associated with increased intestinal permeability and marker of endotoxemia in alcoholics. Am J Physiol Gastrointest Liver Physiol. 2015 Jun 15;308(12):G1004-11. doi: 10.1152/ajpgi.00002.2015. Epub 2015 Apr 23.
- Background: PubMed 28573597Jimenez Morgan S, Molina Mora JA. Effect of Heart Rate Variability Biofeedback on Sport Performance, a Systematic Review. Appl Psychophysiol Biofeedback. 2017 Sep;42(3):235-245. doi: 10.1007/s10484-017-9364-2.
- Background: PubMed 28478782Goessl VC, Curtiss JE, Hofmann SG. The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychol Med. 2017 Nov;47(15):2578-2586. doi: 10.1017/S0033291717001003. Epub 2017 May 8.
- Background: PubMed 29034226Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
- Background: PubMed 16360965Bullinga JR, Alharethi R, Schram MS, Bristow MR, Gilbert EM. Changes in heart rate variability are correlated to hemodynamic improvement with chronic CARVEDILOL therapy in heart failure. J Card Fail. 2005 Dec;11(9):693-9. doi: 10.1016/j.cardfail.2005.06.435.
- Background: PubMed 8941112Tsuji H, Larson MG, Venditti FJ Jr, Manders ES, Evans JC, Feldman CL, Levy D. Impact of reduced heart rate variability on risk for cardiac events. The Framingham Heart Study. Circulation. 1996 Dec 1;94(11):2850-5. doi: 10.1161/01.cir.94.11.2850.
- Background: PubMed 24747432Liu G, Wang L, Wang Q, Zhou G, Wang Y, Jiang Q. A new approach to detect congestive heart failure using short-term heart rate variability measures. PLoS One. 2014 Apr 18;9(4):e93399. doi: 10.1371/journal.pone.0093399. eCollection 2014.
- Background: PubMed 27189911Riaz MS, Atreja A. Personalized Technologies in Chronic Gastrointestinal Disorders: Self-monitoring and Remote Sensor Technologies. Clin Gastroenterol Hepatol. 2016 Dec;14(12):1697-1705. doi: 10.1016/j.cgh.2016.05.009. Epub 2016 May 14.
- Individual participant dataSharing planned: No
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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.
Andrew Tinsley, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Milton S. Hershey Medical Center at 1 site in United States.
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 2 inclusion and 4 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Inflammatory Bowel Disease flares (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04333810, which also lists 15 linked publications.
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 21 Sep 2023.