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Status unknownNCT05501314REMAPUpdated Aug 15, 2022

Remote Home Monitoring Acute Pancreatitis

An interventional study of Early discharge with remote home monitoring. in Acute Pancreatitis, Telemedicine and Healthdot, sponsored by Rijnstate Hospital. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-15.

Sponsored by Rijnstate Hospital · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

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03

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's planned enrollment of 70 is below the median of 80 across 448 interventional studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • 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.

Interventions

  • OtherEarly 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.

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What researchers measure

Primary outcomes

  1. Incidence (%) of unplanned hospital readmissions.

    To determine the feasibility of novel care pathway

    Time frame: Within 30 days of discharge

  2. 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

    Time frame: Within 30 days of discharge

  3. 3. Mortality (%) of patients discharged home with remote monitoring.

    To determine the feasibility of novel care pathway

    Time frame: Within 30 days of discharge

Secondary outcomes

  1. Length of stay in the hospital

    Time frame: Within 30 days of discharge.

  2. 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.

    Time frame: Within 30 days of discharge

  3. The amount of laboratory or imaging tests

    All bloodtests and imaging tests (US, MRI and CT-scan will be documented)

    Time frame: Within 30 days of discharge

  4. Amount of adjustments in analgesics needed during home monitoring

    Time frame: Within 30 days of discharge

Other outcomes

  1. Patient satisfaction is assessed using a satisfaction questionnaire

    Using a combination of two validated questionnaires

    Time frame: After 14 days of discharge.

  2. Overall costs of treatment

    Time frame: Within 30 days of discharge

07

Study locations

1 site
  • Rijnstate Hospital
    Arnhem, Gelderland 6815 AD, Netherlands
    • C.M.J. Doggen, prof. dr. · Contact · +31880056042
    • N. Kant, drs. · Sub investigator
    • B.W.M. Spanier, dr. · Sub investigator
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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05501314
Lead sponsor
Rijnstate Hospital
Collaborators
University of Twente, Philips Research Eindhoven
Responsible party
Sponsor
First posted
Aug 15, 2022
Start date
Oct 2022 (estimated)
Primary completion
Oct 2024 (estimated)
Completion
Apr 2025 (estimated)
Last update
Aug 15, 2022

Study contacts

C.M.J. Doggen, prof. dr.
Contact
REMAPstudy@rijnstate.nl
+31880056042
C.M.J. Doggen, prof. dr.
principal investigator · Rijnstate Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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