Remote Home Monitoring in Mild Acute Pancreatitis

NCT ID: NCT06178172

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2025-10-02

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 patients with a mild acute pancreatitis is mostly supportive, providing this care in the home environment may be feasible with the use of remote monitoring. This might reduce the demand for hospital beds and allow patients to benefit from recovering in their home environment. Therefore, the objective of this single center study is to assess the feasibility of a novel care program in which patients with a predicted mild course of acute pancreatitis are discharged early with remote home monitoring.

Patients, with a predicted mild course of acute pancreatitis. Patients with prior acute pancreatitis within 3 months or a chronic pancreatitis are excluded from participation. Patients should be ≥18 years of age. The goal is to include a total of 70 patients. After at least 48 hours of hospital admission, patients are discharged early with the use of remote home monitoring. At home, patients receive guidance for the management of pain, nutrition and pancreatitis-related complaints by a daily phone call from a nurse from the Virtual Monitoring Centre (VMC). The pancreatitis-related complaints, intake of fluids and food, pain and the use of analgesics are assessed using short questionnaires in a smartphone app. Core temperature is monitored using an ear thermometer and a wearable sensor measures heart rate, respiratory rate, posture and movement every 5 minutes. Remote home monitoring will continue for at least 4 days.

The main study objective is to assess the feasibility of the novel care program. Feasibility is determined by, patient satisfaction and actual use of the novel care program. The secondary study objective is to describe clinical outcomes of patients in the novel care program.

Conditions

Pancreatitis, Acute; Remote Home Monitoring; Early Discharge

Study Design

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

Study Groups

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. At home, patients receive guidance for the management of pain, nutrition and pancreatitis-related complaints by a daily phone call from a nurse from the Virtual Monitoring Centre (VMC). The pancreatitis-related complaints, intake of fluids and food, pain and the use of analgesics are assessed using short questionnaires in a smartphone app. Core temperature is monitored using an ear thermometer and a wearable sensor measures heart rate, respiratory rate, posture and movement every 5 minutes. Remote home monitoring will continue for at least 4 days.

Group Type: EXPERIMENTAL

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. At home, patients receive guidance for the management of pain, nutrition and pancreatitis-related complaints by a daily phone call from a nurse from the Virtual Monitoring Centre (VMC). The pancreatitis-related complaints, intake of fluids and food, pain and the use of analgesics are assessed using short questionnaires in a smartphone app. Core temperature is monitored using an ear thermometer and a wearable sensor measures heart rate, respiratory rate, posture and movement every 5 minutes. Remote home monitoring will continue for at least 4 days.

Interventions

Remote home monitoring

After at least 48 hours of hospital admission, patients are discharged early with the use of remote home monitoring. At home, patients receive guidance for the management of pain, nutrition and pancreatitis-related complaints by a daily phone call from a nurse from the Virtual Monitoring Centre (VMC). The pancreatitis-related complaints, intake of fluids and food, pain and the use of analgesics are assessed using short questionnaires in a smartphone app. Core temperature is monitored using an ear thermometer and a wearable sensor measures heart rate, respiratory rate, posture and movement every 5 minutes. Remote home monitoring will continue for at least 4 days.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Acute pancreatitis according to the revised Atlanta criteria for pancreatitis(23). Which is at least 2 of the following 3 criteria:

• 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 Dutch
• In possession of a working (smart)phone on which patient can be reached for the duration of participation (30 days)
• ≤1 SIRS criteria

• Temperature < 36◦C or > 38◦C
• Heart rate >90/min
• Respiratory rate >20/min
• Leucocytes < 4x/109/L or > 12x109/L
• Serum CRP ≤ 150 mg/l on day of discharge and with a decreasing trend in days before
• Pain score (NRS) ≤6 with or without the use of pain medication
• Adequate intake of oral food and fluids (= ≥2 small meals and ≥1L fluids per day)
• Stable serum creatinine and Ringer's lactate infusion reduced to ≤1L/24 hours
• Independent in performing general daily life activities

Exclusion Criteria

• Chronic pancreatitis according to M-ANNHEIM criteria(24).
• Acute cholangitis
• Endoscopic retrograde cholangiopancreatography within the first 24 hours of admission
• MEWS (Modified Early Warning Score) ≥6 or in need of ICU admission
• Living in an institution (e.g. psychiatric ward or nursing home), or the absence of a household member capable of alerting the hospital in case of an emergency 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

Locations

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Rijnstate Hospital

Arnhem, , Netherlands

Countries

Netherlands

Facility Contacts

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

Role: primary

Other Identifiers

NL84869.100.23

Identifier Type: -

Identifier Source: org_study_id