Remote Home Monitoring Acute Pancreatitis (REMAP)

Rijnstate Hospital

Status: Not yet enrolling

Conditions: Acute Pancreatitis; Telemedicine; Healthdot; Monitoring; Patient Discharge

Treatments: Other: Early discharge with remote home monitoring.

Study type: Interventional

Funder types: Other

Identifiers

NCT05501314

NL81630.091.22

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Early discharge with remote home monitoring.

Experimental group

Description:

* Patients are discharged early * Patients receive remote home monitoring using a wearable sensor and a smartphone app. * Patients fill in a satisfaction questionnaire

Treatment:

Other: Early discharge with remote home monitoring.