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Implementation of a remote home monitoring program for patients with a mild acute pancreatitis - A multicenter feasibility study (INTERACT)

Implementation of a remote home monitoring program for patients with a mild acute pancreatitis - A multicenter feasibility study (INTERACT) - INTERACT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53197
Enrollment
70
Registered
2023-11-16
Start date
2024-01-18
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute inflammation of the pancreas acute pancreatitis

Interventions

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 panc

Sponsors

Rijnstate Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Acute pancreatitis according to the revised Atlanta criteria for pancreatiti. 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) • 38*C * heart rate > 90/min * respiratory rate >20/min * leucocytes 12x109/l • Serum CRP =2 small meals and >=1L fluids per day) • Stable serum creatinine and Ringer's lactate infusion reduced to

Exclusion criteria

Exclusion criteria: • Chronic pancreatitis according to M-ANNHEIM criteria. • 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

Design outcomes

Primary

MeasureTime frame
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, for which the following parameters will be assessed: Patient satisfaction: - Satisfaction with overall care (from GE-ward admittance until discontinuation of remote home monitoring) - Satisfaction with smartphone app - Satisfaction with wearable sensor (Rijnstate) - Intent to participate in the care program again Actual use of the novel care program: - Proportion of patients willing and able to participate - Time between discharge decision and actual hospital discharge - Duration of remote home monitoring - Number of contacts between patients and healthcare professionals - Number of additional laboratory tests - Smartphone app functionality (generated notifications, time between notification and contact with VMC-nurse and questionnaire compliance) - Wearable sensor functionality (missing data and accidental detachment) (Rijnstate)

Secondary

MeasureTime frame
The secondary study objective is to describe clinical outcomes of patients in the novel care program, for which the following parameters will be assessed: - Utilization of analgesics and anti-emetics - Pain scores - Food tolerance - Activity levels - Time between GE ward admission and discharge decision - Hospital readmissions within 30 days of hospital admission - Emergency department (ED) revisits within 30 days of hospital admission - Pancreatitis-related complications within 30 days of hospital admission - Mortality within 30 days of hospital admission

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 3, 2026