Clinical trial NCT06178172: Remote Home Monitoring in Mild Acute Pancreatitis
Official title: Implementation of a Remote Home Monitoring Program for Patients With a Mild Acute Pancreatitis - A Single Center Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatitis, Acute
Remote Home Monitoring
Early Discharge
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: University of Twente
name: Philips Research Eindhoven
First posted: 2023-12-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Patient satisfaction with overall care, based on satisfaction questionnaire
timeFrame: Within 30 days of hospital admission
measure: Patient satisfaction with smartphone app (Luscii), based on satisfaction questionnaire
timeFrame: Within 30 days of hospital admission
measure: Patient satisfaction with wearable sensor (Healthdot), based on satisfaction questionnaire
timeFrame: Within 30 days of hospital admission
measure: Patient intent to participate in the care program again
timeFrame: Within 30 days of hospital admission
measure: Proportion of patients willing and able to participate
timeFrame: Within 30 days of hospital admission
measure: Time between discharge decision and actual hospital discharge in days
timeFrame: Within 30 days of hospital admission
measure: Duration of remote home monitoring in days
timeFrame: Within 30 days of hospital admission
measure: Number of contacts between patients and healthcare professionals
timeFrame: Within 30 days of hospital admission
measure: Number of additional laboratory tests (during home monitoring)
timeFrame: Within 30 days of hospital admission
measure: Smartphone app functionality, determined by generated notifications, time between notification and contact with VMC-nurse and questionnaire compliance
timeFrame: Within 30 days of hospital admission
measure: Wearable sensor functionality, determined by the amount of missing data and accidental detachments
timeFrame: Within 30 days of hospital admission
Secondary outcomes:
measure: Use of analgesics and anti-emetics, described as the number of days used
timeFrame: Within 30 days of hospital admission
measure: Pain scores, based on NRS (0-10)
timeFrame: Within 30 days of hospital admission
measure: Intake of food and fluids, described as number of meals and liters of fluid intake
timeFrame: Within 30 days of hospital admission
measure: Activity levels, as measured by the wearable sensor (0-10)
timeFrame: Within 30 days of hospital admission
measure: Time between GE ward admission and discharge decision in days
timeFrame: Within 30 days of hospital admission
measure: Hospital readmissions
timeFrame: Within 30 days of hospital admission
measure: Emergency department (ED) revisits
timeFrame: Within 30 days of hospital admission
measure: Pancreatitis-related complications
timeFrame: Within 30 days of hospital admission
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
References: