Remote Home Monitoring Acute Pancreatitis

Telemedicine Clinical Trial

— REMAP  

Official title:

Remote Home Monitoring of Patients With a Predicted Mild Acute Pancreatitis - A Feasibility Study (REMAP)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05501314
• Other study ID #: NL81630.091.22
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: April 2025

Study information

• Verified date: August 2022
• Source: Rijnstate Hospital
• Contact: C.M.J. Doggen, prof. dr.
• Phone: +31880056042
• Email: REMAPstudy[@]rijnstate.nl
• 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 a mild acute pancreatitis is supportive, early discharge of patients with a predicted mild course of acute pancreatitis might be safe with the use of remote home monitoring. This might reduce the demand for hospital beds and allow patients to benefit from recovering in their home environment. Therefore, the aim of this study is to assess the feasibility of a novel care pathway in which patients with a predicted mild course of acute pancreatitis are discharged early with remote home monitoring.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: April 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have 2 out of 3 revised Atlanta criteria for pancreatitis:
• 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 possession of a working (smart)phone on which patient can be reached for the duration of participation (30 days).

Exclusion Criteria:

• Chronic pancreatitis according to M-ANNHEIM criteria (20).
• Signs of severe pancreatitis at the moment of admission to the GE ward:
• Serum CRP > 150 mg/l
• More than one SIRS criteria:
• temperature < 36?C or > 38?C
• heart rate > 90/min
• respiratory rate >20/min
• leucocytes < 4x/109l or > 12x109/l
• MEWS (Modified Early Warning Score) =6 or in need of ICU admission
• Living alone or in an institution (e.g. psychiatric ward or nursing home)
• 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

• Acute Pancreatitis
• Monitoring
• Pancreatitis
• Patient Discharge
• Telemedicine

Intervention

Other:
• Early discharge with remote home monitoring.
After at least 48 hours of hospital admission, patients are discharged early with the use of remote home monitoring. During home monitoring, heartrate, respiratory rate, posture and movement are monitored every 5 minutes for at least 4 days, using a wearable sensor. Core temperature is monitored using an ear thermometer. Patients are contacted once per day by a nurse from the Virtual Monitoring Centre (VMC) to assess pancreatitis related complaints, intake of fluids and food, pain and the use of analgesics. Patients are asked to provide information to the hospital using a smartphone app.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

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
Other	Patient satisfaction is assessed using a satisfaction questionnaire	Using a combination of two validated questionnaires	After 14 days of discharge.
Other	Overall costs of treatment		Within 30 days of discharge
Primary	Incidence (%) of unplanned hospital readmissions.	To determine the feasibility of novel care pathway	Within 30 days of discharge
Primary	2. Incidence (%) of pancreatitis related complications. These complications include necrotizing pancreatitis, infection, pseudocysts, new onset diabetes, recurrence of pancreatitis, cholecystitis or cholangitis.	To determine the feasibility of novel care pathway	Within 30 days of discharge
Primary	3. Mortality (%) of patients discharged home with remote monitoring.	To determine the feasibility of novel care pathway	Within 30 days of discharge
Secondary	Length of stay in the hospital		Within 30 days of discharge.
Secondary	The amount of extra contacts between VMC-nurse or physician and the patient, in addition to the usual call once per day as documented in the smartphone app.		Within 30 days of discharge
Secondary	The amount of laboratory or imaging tests	All bloodtests and imaging tests (US, MRI and CT-scan will be documented)	Within 30 days of discharge
Secondary	Amount of adjustments in analgesics needed during home monitoring		Within 30 days of discharge