Back to results

Remote Home Monitoring Acute Pancreatitis (REMAP)

Primary Purpose

Acute Pancreatitis, Telemedicine, Healthdot

Status

Not yet recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Early discharge with remote home monitoring.

About this trial

This is an interventional other trial for Acute Pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rijnstate Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Early discharge with remote home monitoring.

Arm Description

Patients are discharged early Patients receive remote home monitoring using a wearable sensor and a smartphone app. Patients fill in a satisfaction questionnaire

Outcomes

Primary Outcome Measures

Incidence (%) of unplanned hospital readmissions.

To determine the feasibility of novel care pathway

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

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

To determine the feasibility of novel care pathway

Secondary Outcome Measures

Length of stay in the hospital

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.

The amount of laboratory or imaging tests

All bloodtests and imaging tests (US, MRI and CT-scan will be documented)

Amount of adjustments in analgesics needed during home monitoring

Full Information

NCT ID

NCT05501314

First Posted

August 8, 2022

Last Updated

August 11, 2022

Sponsor

Rijnstate Hospital

Collaborators

University of Twente, Philips Research Eindhoven

1. Study Identification

Unique Protocol Identification Number

NCT05501314

Brief Title

Remote Home Monitoring Acute Pancreatitis

Acronym

REMAP

Official Title

Remote Home Monitoring of Patients With a Predicted Mild Acute Pancreatitis - A Feasibility Study (REMAP)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2022 (Anticipated)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rijnstate Hospital

Collaborators

University of Twente, Philips Research Eindhoven

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pancreatitis, Telemedicine, Healthdot, Patient Discharge, Monitoring

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Feasibility study

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early discharge with remote home monitoring.

Arm Type

Experimental

Arm Description

Patients are discharged early Patients receive remote home monitoring using a wearable sensor and a smartphone app. Patients fill in a satisfaction questionnaire

Intervention Type

Other

Intervention Name(s)

Early discharge with remote home monitoring.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence (%) of unplanned hospital readmissions.

Description

To determine the feasibility of novel care pathway

Time Frame

Within 30 days of discharge

Title

Description

To determine the feasibility of novel care pathway

Time Frame

Within 30 days of discharge

Title

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

Description

To determine the feasibility of novel care pathway

Time Frame

Within 30 days of discharge

Secondary Outcome Measure Information:

Title

Length of stay in the hospital

Time Frame

Within 30 days of discharge.

Title

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.

Time Frame

Within 30 days of discharge

Title

The amount of laboratory or imaging tests

Description

All bloodtests and imaging tests (US, MRI and CT-scan will be documented)

Time Frame

Within 30 days of discharge

Title

Amount of adjustments in analgesics needed during home monitoring

Time Frame

Within 30 days of discharge

Other Pre-specified Outcome Measures:

Title

Patient satisfaction is assessed using a satisfaction questionnaire

Description

Using a combination of two validated questionnaires

Time Frame

After 14 days of discharge.

Title

Overall costs of treatment

Time Frame

Within 30 days of discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

+31880056042

REMAPstudy@rijnstate.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Rijnstate Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rijnstate Hospital

City

Arnhem

State/Province

Gelderland

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

Phone

+31880056042

First Name & Middle Initial & Last Name & Degree

N. Kant, drs.

First Name & Middle Initial & Last Name & Degree

B.W.M. Spanier, dr.

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Remote Home Monitoring Acute Pancreatitis

We'll reach out to this number within 24 hrs