Remote Home Monitoring Acute Pancreatitis

NCT05501314 | Unknown

• 1 other identifier: NL81630.091.22
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Incidence (%) of unplanned hospital readmissions.

  To determine the feasibility of novel care pathway

  Within 30 days of discharge

• 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

  Within 30 days of discharge

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

  To determine the feasibility of novel care pathway

  Within 30 days of discharge

Secondary Outcomes (4)

• Length of stay in the hospital

  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

• The amount of laboratory or imaging tests

  Within 30 days of discharge

• Amount of adjustments in analgesics needed during home monitoring

  Within 30 days of discharge

Other Outcomes (2)

• Patient satisfaction is assessed using a satisfaction questionnaire

  After 14 days of discharge.

• Overall costs of treatment

  Within 30 days of discharge

Study Arms (1)

Early discharge with remote home monitoring.

EXPERIMENTAL

* 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

Early discharge with remote home monitoring. 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.

Early discharge with remote home monitoring.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rijnstate Hospital: lead
• University of Twente: collaborator
• Philips Research Eindhoven: collaborator

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6815 AD, Netherlands

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• C.M.J. Doggen, prof. dr.

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+31880056042; REMAPstudy@rijnstate.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility study

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 15, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)