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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Howdy Senior® device | Device | Standard perioperative management plus three preoperative and twelve postoperative (until 90 days after surgery) HOWDY Senior® device assessments. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 14 days to 1 day before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annalisa Maroli, PhD | Contact | 02 8224 7776 | 0039 | colorapp@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonino Spinelli, MD, PhD | IRCCS Huamanitas Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Humanitas Research Hospital | Recruiting | Rozzano | MI | 20089 | Italy |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Single-center, interventional, case-series study with a historical cohort of comparison
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| 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). | 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. | 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. | 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. | 90 days after surgery |
| Healthcare costs | Median difference of the healthcare resources used in the interventional cohort and the historical cohort of comparison. | 6 months after surgery |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |