Remote Home Monitoring Acute Pancreatitis

Not Applicable

Not yet recruiting

• Conditions: Acute Pancreatitis; Patient Discharge; Monitoring; Telemedicine; Healthdot
• Interventions: Other: Early discharge with remote home monitoring.

• Registration Number: NCT05501314
• Lead Sponsor: Rijnstate Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-11
• Last Update Submitted: 2022-08-11
• Study First Posted: 2022-08-15
• Last Update Posted: 2022-08-15
• Study Start: 2022-10
• Primary Completion: 2024-10
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early discharge with remote home monitoring.	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

Primary Outcome Measures

Name	Time	Method
2. Incidence (%) of pancreatitis related complications. These complications include necrotizing pancreatitis, infection, pseudocysts, new onset diabetes, recurrence of pancreatitis, cholecystitis or cholangitis.	Within 30 days of discharge	To determine the feasibility of novel care pathway
3. Mortality (%) of patients discharged home with remote monitoring.	Within 30 days of discharge	To determine the feasibility of novel care pathway
Incidence (%) of unplanned hospital readmissions.	Within 30 days of discharge	To determine the feasibility of novel care pathway

Secondary Outcome Measures

Name	Time	Method
The amount of laboratory or imaging tests	Within 30 days of discharge	All bloodtests and imaging tests (US, MRI and CT-scan will be documented)
Length of stay in the hospital	Within 30 days of discharge.
Amount of adjustments in analgesics needed during home monitoring	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

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands