Inflammatory Bowel DiseasesPeRseoNCT06299423
Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients
A study testing Howdy Senior® device in people with Inflammatory Bowel Diseases and Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Anxiety and depression are extremely common among Inflammatory Bowel Disease (IBD) patients undergoing surgery and may increase the risk of postoperative adverse outcomes. This study aims to objectively evaluate preoperative psychological distress by remotely measuring the patient's physiological parameters and Heart… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Surgery
- What is being tested?
- Howdy Senior® device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 22 Nov 2023to 30 Nov 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged more than 18 years old.
- Established Crohn's disease (CD) or Ulcerative Colitis (UC) at the time of surgery indication with a proven histological diagnosis.
- Patients scheduled for elective intestinal resection.
Who cannot join
- Diagnosis of Undetermined Colitis.
- Recurrent disease.
- Concomitant diagnosis of malignancy.
- Established diagnosis of major depressive disorder or anxiety disorder.
- Diagnosis of ventricular or supraventricular arrythmia.
- Active pharmacological treatment with β-blockers or other drugs affecting the heart rate.
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- Known hypersensitivity to cotton or silver.
- Emergent surgery.
- Planned open surgery.
- Any concomitant surgery unrelated to the main surgical indication. Patients undergoing perianal surgery for related perianal disease can be included in the study.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Humanitas Research Hospital
Rozzano, MI, 20089
Annalisa Maroli, PhD, 02 8224 7776 ext. 0039, colorapp@humanitas.it
About this study
Official title: Perioperative Electrocardiogram Remote Monitoring to Assess Preoperative Psychological Distress and Improve Postoperative Recovery in Inflammatory Bowel Disease Surgery: a Pilot Single-arm Prospective Study
Anxiety and depression are extremely common among Inflammatory Bowel Disease (IBD) patients undergoing surgery and may increase the risk of postoperative adverse outcomes. This study aims to objectively evaluate preoperative psychological distress by remotely measuring the patient's physiological parameters and Heart Rate Variability (HRV) with the Howdy Senior ® device (Comftech Srl). Additionally, the study will also investigate the feasibility and effectiveness of the Howdy Senior® device in improving the postoperative patient's monitoring.
Read the detailed description
Inflammatory Bowel Disease (IBD) patients are at high risk of postoperative complications and delayed recovery. Preoperative anxiety and low patient's awareness of the disease may increase the risk of postoperative complications inducing an autonomic impairment which may in turn determine an inflammatory unbalance. This correlation can be confirmed through the preoperative monitoring of the autonomic function- with wearable electrocardiogram (ECG) devices. The Howdy Senior® device (ComfTech Srl) allows the real-time remote ECG monitoring and the computation of stress and fatigue indexes.
The Howdy Senior® device may also provide a reliable tool for remotely monitoring the patient's clinical parameters after discharge.
This study aims to explore the pathophysiological mechanisms linking preoperative anxiety and autonomic response and assess the feasibility and effectiveness of the Howdy Senior® device for the postoperative patients' remote monitoring.
- Conditions
- Inflammatory Bowel Diseases, Surgery
- Being tested
- Howdy Senior® device
- Keywords
- Inflammatory Bowel Disease, Surgery, Anxiety and Depression
- Medical subject headings
- Inflammatory Bowel Diseases, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Howdy Senior® deviceDevice
Standard perioperative management plus three preoperative and twelve postoperative (until 90 days after surgery) HOWDY Senior® device assessments.
| Study group | Role | What they receive |
|---|---|---|
| Howdy Senior® device | Experimental | Patients will undergo standard perioperative management. Additionally, patients will perform three preoperative and twelve postoperative HOWDY Senior® assessments. The assessment consists of a nocturnal electrocardiogram (ECG) measure and a morning rest Heart Rate Variability (HRV) measure of five minutes. Receives: Device: Howdy Senior® device |
| Standard perioperative management | No intervention | Patients belonging to the historical cohort of comparison, who underwent standard perioperative management and surgical intervention between January 2021 and January 2022. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between preoperative anxiety and preoperative Heart Rate Variability (HRV)
Correlation between preoperative anxiety- assessed through the Hospital Anxiety and Depression Scale (HADS) (Self-reporting scale ranging from 0 to 21, where significant anxiety and depression are identified by a 8 point cut-off) and the median value of at least three Heart Rate Variability (HRV) measures collected in the preoperative period through the Howdy Senior® device.
Measured: From 14 days to 1 day before surgery
Secondary outcomes (6)
Correlation between preoperative anxiety and 90-day Comprehensive Complication Index (CCI)
Correlation between preoperative anxiety- assessed through the Hospital Anxiety and Depression Scale (HADS) (Self-reporting scale ranging from 0 to 21, where significant anxiety and depression are identified by a 8 point cut-off) and the median value of the Comprehensive Complication Index (CCI) (Index ranging from 0 (no complication) to 100 (death)) at 90 days after the surgical intervention
Measured: 90 days after surgery
Correlation between preoperative anxiety and preoperative Patient Health Engagement Scale (PHE-S)
Correlation between preoperative anxiety- assessed through the Hospital Anxiety and Depression Scale (HADS) (Self-reported scale ranging from 0 to 21, where significant anxiety and depression are identified by a 8 point cut-off) and the preoperative Patient Health Engagement Scale (PHE-S, self-reporting scale ranging from 0 (complete disease awareness) to 12 (complete absence of disease awareness).
Measured: From 14 days to 1 day before surgery
Correlation between preoperative anxiety and C-Reactive Protein (CRP) level 24 hour after surgery
Correlation between preoperative anxiety- assessed through the Hospital Anxiety and Depression Scale (HADS) (Self-reported scale ranging from 0 to 21, where significant anxiety and depression are identified by a 8 point cut-off) and the level of serum C-Reactive Protein (CRP, µg/mL) measured 24 hours after surgery.
Measured: 24 hours after surgery
90-day postoperative complications
Rate difference of 90-day postoperative complications (classified according to the Clavien-Dindo scale) between the interventional cohort and the historical cohort of comparison.
Measured: 90 days after surgery
Correlation between the 90-day Postoperative Recovery Profile (PRP) and 90-day Heart Rate Variability (HRV)
Correlation between the 90-day Postoperative Recovery Profile (PRP) (Scale ranging from 0 (completely recovered) to 68 (not recovered)) and the median value of at least twelve Heart Rate Variability (HRV) measures collected in the postoperative period through the Howdy Senior® device.
Measured: 90 days after surgery
Healthcare costs
Median difference of the healthcare resources used in the interventional cohort and the historical cohort of comparison.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start22 Nov 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Single-center, interventional, case-series study with a historical cohort of comparison
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonino Spinelli, MD, PhD, Principal investigator, IRCCS Huamanitas Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299423
- Sponsor's protocol ID
- 3677
- Acronym
- PeRseo
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Electrocardiogram Remote Monitoring to Assess Preoperative Psychological Distress and Improve Postoperative Recovery in Inflammatory Bowel Disease Surgery: a Pilot Single-arm Prospective Study
- ClinicalTrials.gov ID
- NCT06299423
- Acronym / sponsor ID
- PeRseo / 3677
- Conditions
- Inflammatory Bowel Diseases, Surgery
- Keywords
- Inflammatory Bowel Disease, Surgery, Anxiety and Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 7 Mar 2024 (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.
Anxiety and depression are extremely common among Inflammatory Bowel Disease (IBD) patients undergoing surgery and may increase the risk of postoperative adverse outcomes. This study aims to objectively evaluate preoperative psychological distress by remotely measuring the patient's physiological parameters and Heart Rate Variability (HRV) with the Howdy Senior ® device (Comftech Srl). Additionally, the study will also investigate the feasibility and effectiveness of the Howdy Senior® device in improving the postoperative patient's monitoring.
Detailed description
Inflammatory Bowel Disease (IBD) patients are at high risk of postoperative complications and delayed recovery. Preoperative anxiety and low patient's awareness of the disease may increase the risk of postoperative complications inducing an autonomic impairment which may in turn determine an inflammatory unbalance. This correlation can be confirmed through the preoperative monitoring of the autonomic function- with wearable electrocardiogram (ECG) devices. The Howdy Senior® device (ComfTech Srl) allows the real-time remote ECG monitoring and the computation of stress and fatigue indexes.
The Howdy Senior® device may also provide a reliable tool for remotely monitoring the patient's clinical parameters after discharge.
This study aims to explore the pathophysiological mechanisms linking preoperative anxiety and autonomic response and assess the feasibility and effectiveness of the Howdy Senior® device for the postoperative patients' remote monitoring.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, interventional, case-series study with a historical cohort of comparison
| Arm | Type | Receives |
|---|---|---|
| Howdy Senior® device | Experimental | Device: Howdy Senior® devicePatients will undergo standard perioperative management. Additionally, patients will perform three preoperative and twelve postoperative HOWDY Senior® assessments. The assessment consists of a nocturnal electrocardiogram (ECG) measure and a morning rest Heart Rate Variability (HRV) measure of five minutes. |
| Standard perioperative management | No intervention | –Patients belonging to the historical cohort of comparison, who underwent standard perioperative management and surgical intervention between January 2021 and January 2022. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged more than 18 years old.
- Established Crohn's disease (CD) or Ulcerative Colitis (UC) at the time of surgery indication with a proven histological diagnosis.
- Patients scheduled for elective intestinal resection.
Key exclusion criteria (10 listed)
- Diagnosis of Undetermined Colitis.
- Recurrent disease.
- Concomitant diagnosis of malignancy.
- Established diagnosis of major depressive disorder or anxiety disorder.
- Diagnosis of ventricular or supraventricular arrythmia.
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 |
|---|---|---|
| Howdy Senior® deviceStandard perioperative management plus three preoperative and twelve postoperative (until 90 days after surgery) HOWDY Senior® device assessments. | Device | Howdy Senior® device |
Primary outcome
Correlation between preoperative anxiety and preoperative Heart Rate Variability (HRV)
Time frame: From 14 days to 1 day before surgery
Correlation between preoperative anxiety- assessed through the Hospital Anxiety and Depression Scale (HADS) (Self-reporting scale ranging from 0 to 21, where significant anxiety and depression are identified by a 8 point cut-off) and the median value of at least three Heart Rate Variability (HRV) measures collected in the preoperative period through the Howdy Senior® device.
6 secondary outcomes
Correlation between preoperative anxiety and 90-day Comprehensive Complication Index (CCI)
Time frame: 90 days after surgery
Correlation between preoperative anxiety and preoperative Patient Health Engagement Scale (PHE-S)
Time frame: From 14 days to 1 day before surgery
Correlation between preoperative anxiety and C-Reactive Protein (CRP) level 24 hour after surgery
Time frame: 24 hours after surgery
90-day postoperative complications
Time frame: 90 days after surgery
Correlation between the 90-day Postoperative Recovery Profile (PRP) and 90-day Heart Rate Variability (HRV)
Time frame: 90 days after surgery
Healthcare costs
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- 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.
Antonino Spinelli, MD, PhD principal investigator
IRCCS Huamanitas Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Howdy Senior® device in people with Inflammatory Bowel Diseases and Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annalisa Maroli, PhD (02 8224 7776 ext. 0039, colorapp@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between preoperative anxiety and preoperative Heart Rate Variability (HRV) (time frame: From 14 days to 1 day before surgery). 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 8 Mar 2024.