Remote Home Monitoring in Mild Acute Pancreatitis

Pancreatitis, Acute Clinical Trial

— INTERACT  

Official title:

Implementation of a Remote Home Monitoring Program for Patients With a Mild Acute Pancreatitis - A Single Center Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06178172
• Other study ID #: NL84869.100.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: October 2, 2025

Study information

• Verified date: December 2023
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute pancreatitis is an inflammation of the pancreas which causes abdominal pain and is the most common gastro-intestinal reason for acute hospitalization in Western countries. Because care for patients with a mild acute pancreatitis is mostly supportive, providing this care in the home environment may be feasible with the use of remote monitoring. This might reduce the demand for hospital beds and allow patients to benefit from recovering in their home environment. Therefore, the objective of this single center study is to assess the feasibility of a novel care program in which patients with a predicted mild course of acute pancreatitis are discharged early with remote home monitoring. Patients, with a predicted mild course of acute pancreatitis. Patients with prior acute pancreatitis within 3 months or a chronic pancreatitis are excluded from participation. Patients should be ≥18 years of age. The goal is to include a total of 70 patients. After at least 48 hours of hospital admission, patients are discharged early with the use of remote home monitoring. At home, patients receive guidance for the management of pain, nutrition and pancreatitis-related complaints by a daily phone call from a nurse from the Virtual Monitoring Centre (VMC). The pancreatitis-related complaints, intake of fluids and food, pain and the use of analgesics are assessed using short questionnaires in a smartphone app. Core temperature is monitored using an ear thermometer and a wearable sensor measures heart rate, respiratory rate, posture and movement every 5 minutes. Remote home monitoring will continue for at least 4 days. The main study objective is to assess the feasibility of the novel care program. Feasibility is determined by, patient satisfaction and actual use of the novel care program. The secondary study objective is to describe clinical outcomes of patients in the novel care program.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: October 2, 2025
• Est. primary completion date: June 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute pancreatitis according to the revised Atlanta criteria for pancreatitis(23).

Which is at least 2 of the following 3 criteria:

• Abdominal pain consistent with acute pancreatitis
• Serum lipase = 3x upper limit normal (> 159 U/l)
• Typical pancreatic abnormalities on imaging (ultrasound, CT or MRI)
• First episode of acute pancreatitis or a prior pancreatitis more than 3 months ago
• Age =18 years, both men and women
• Able and willing to provide written informed consent in Dutch
• In possession of a working (smart)phone on which patient can be reached for the duration of participation (30 days)
• =1 SIRS criteria
• Temperature < 36?C or > 38?C
• Heart rate >90/min
• Respiratory rate >20/min
• Leucocytes < 4x/109/L or > 12x109/L
• Serum CRP = 150 mg/l on day of discharge and with a decreasing trend in days before
• Pain score (NRS) =6 with or without the use of pain medication
• Adequate intake of oral food and fluids (= =2 small meals and =1L fluids per day)
• Stable serum creatinine and Ringer's lactate infusion reduced to =1L/24 hours
• Independent in performing general daily life activities

Exclusion Criteria:

• Chronic pancreatitis according to M-ANNHEIM criteria(24).
• Acute cholangitis
• Endoscopic retrograde cholangiopancreatography within the first 24 hours of admission
• MEWS (Modified Early Warning Score) =6 or in need of ICU admission
• Living in an institution (e.g. psychiatric ward or nursing home), or the absence of a household member capable of alerting the hospital in case of an emergency Known sensitivity to medical adhesives
• Known pregnancy
• Have one or more of the following comorbidities:
• Heart failure (NYHA class III or IV)
• COPD (Gold III-IV)
• Kidney disease (>G3b) and/or kidney replacement therapy
• Currently undergoing oncological treatment
• Use of immunosuppressants
• Dysregulated or poorly controlled insulin dependent diabetes
• Morbid obesity (BMI>35 kg/m2)
• Implantable Cardioverter Defibrillator (ICD) or Pacemaker

Related Conditions & MeSH terms

• Early Discharge
• Pancreatitis
• Pancreatitis, Acute

Intervention

Other:
• Remote home monitoring
After at least 48 hours of hospital admission, patients are discharged early with the use of remote home monitoring. At home, patients receive guidance for the management of pain, nutrition and pancreatitis-related complaints by a daily phone call from a nurse from the Virtual Monitoring Centre (VMC). The pancreatitis-related complaints, intake of fluids and food, pain and the use of analgesics are assessed using short questionnaires in a smartphone app. Core temperature is monitored using an ear thermometer and a wearable sensor measures heart rate, respiratory rate, posture and movement every 5 minutes. Remote home monitoring will continue for at least 4 days.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (3)

Lead Sponsor	Collaborator
Rijnstate Hospital	Philips Research Eindhoven, University of Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction with overall care, based on satisfaction questionnaire	Overall care from GE-ward admittance until discontinuation of remote home monitoring.	Within 30 days of hospital admission
Primary	Patient satisfaction with smartphone app (Luscii), based on satisfaction questionnaire		Within 30 days of hospital admission
Primary	Patient satisfaction with wearable sensor (Healthdot), based on satisfaction questionnaire		Within 30 days of hospital admission
Primary	Patient intent to participate in the care program again	Based on satisfaction questionnaire	Within 30 days of hospital admission
Primary	Proportion of patients willing and able to participate		Within 30 days of hospital admission
Primary	Time between discharge decision and actual hospital discharge in days		Within 30 days of hospital admission
Primary	Duration of remote home monitoring in days		Within 30 days of hospital admission
Primary	Number of contacts between patients and healthcare professionals		Within 30 days of hospital admission
Primary	Number of additional laboratory tests (during home monitoring)		Within 30 days of hospital admission
Primary	Smartphone app functionality, determined by generated notifications, time between notification and contact with VMC-nurse and questionnaire compliance		Within 30 days of hospital admission
Primary	Wearable sensor functionality, determined by the amount of missing data and accidental detachments		Within 30 days of hospital admission
Secondary	Use of analgesics and anti-emetics, described as the number of days used		Within 30 days of hospital admission
Secondary	Pain scores, based on NRS (0-10)		Within 30 days of hospital admission
Secondary	Intake of food and fluids, described as number of meals and liters of fluid intake		Within 30 days of hospital admission
Secondary	Activity levels, as measured by the wearable sensor (0-10)		Within 30 days of hospital admission
Secondary	Time between GE ward admission and discharge decision in days		Within 30 days of hospital admission
Secondary	Hospital readmissions		Within 30 days of hospital admission
Secondary	Emergency department (ED) revisits	An ED revisit followed by a hospital readmission will be documented as a hospital readmission	Within 30 days of hospital admission
Secondary	Pancreatitis-related complications	Pseudocysts, necrosis, etc.	Within 30 days of hospital admission