Remote Home Monitoring Acute Pancreatitis (REMAP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Telemedicine; Acute Pancreatitis; Monitoring; Patient Discharge; Healthdot
• Intervention / Treatment: Other: Early discharge with remote home monitoring.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: C.M.J. Doggen, prof. dr.; Phone Number: +31880056042; Email: REMAPstudy@rijnstate.nl

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815 AD
      • Rijnstate Hospital
      • Contact: C.M.J. Doggen, prof. dr.; Phone Number: +31880056042
      • Sub-Investigator: N. Kant, drs.
      • Sub-Investigator: B.W.M. Spanier, dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Early discharge with remote home monitoring.; Patients are discharged early; Patients receive remote home monitoring using a wearable sensor and a smartphone app.; Patients fill in a satisfaction questionnaire

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence (%) of unplanned hospital readmissions.	To determine the feasibility of novel care pathway	Within 30 days of discharge
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
3. Mortality (%) of patients discharged home with remote monitoring.	To determine the feasibility of novel care pathway	Within 30 days of discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in the hospital		Within 30 days of discharge.
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
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
Amount of adjustments in analgesics needed during home monitoring		Within 30 days of discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction is assessed using a satisfaction questionnaire	Using a combination of two validated questionnaires	After 14 days of discharge.
Overall costs of treatment		Within 30 days of discharge

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: University of Twente; Philips Research Eindhoven
• Investigators: Principal Investigator: C.M.J. Doggen, prof. dr., Rijnstate Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): October 1, 2024
• Study Completion (ANTICIPATED): April 1, 2025

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (ACTUAL): August 15, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: NL81630.091.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No