Remote Home Monitoring Acute Pancreatitis

NCT ID: NCT05501314

Last Updated: 2022-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2025-04-30

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.

Conditions

Acute Pancreatitis; Telemedicine; Healthdot; Patient Discharge; Monitoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Early discharge with remote home monitoring.

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Twente

OTHER

Sponsor Role: collaborator

Philips Research Eindhoven

UNKNOWN

Sponsor Role: collaborator

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

C.M.J. Doggen, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Locations

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Countries

Netherlands

Central Contacts

C.M.J. Doggen, prof. dr.

Role: CONTACT

REMAPstudy@rijnstate.nl

+31880056042

Facility Contacts

C.M.J. Doggen, prof. dr.

Role: primary

+31880056042

Other Identifiers

NL81630.091.22

Identifier Type: -

Identifier Source: org_study_id