Acute PancreatitisREMAPNCT05501314
Remote Home Monitoring Acute Pancreatitis
A study testing Early discharge with remote home monitoring. in people with Acute Pancreatitis and Telemedicine, run by Rijnstate Hospital at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis, Telemedicine, Healthdot
- What is being tested?
- Early discharge with remote home monitoring.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2022to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Rijnstate Hospital
Arnhem, Gelderland, 6815 AD
C.M.J. Doggen, prof. dr., +31880056042
N. Kant, drs.
About this study
Official title: Remote Home Monitoring of Patients With a Predicted Mild Acute Pancreatitis - A Feasibility Study (REMAP)
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
- Being tested
- Early discharge with remote home monitoring.
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Early discharge with remote home monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence (%) of unplanned hospital readmissions.
To determine the feasibility of novel care pathway
Measured: 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
Measured: Within 30 days of discharge
3. Mortality (%) of patients discharged home with remote monitoring.
To determine the feasibility of novel care pathway
Measured: Within 30 days of discharge
Secondary outcomes (4)
Length of stay in the hospital
Measured: 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.
Measured: Within 30 days of discharge
The amount of laboratory or imaging tests
All bloodtests and imaging tests (US, MRI and CT-scan will be documented)
Measured: Within 30 days of discharge
Amount of adjustments in analgesics needed during home monitoring
Measured: Within 30 days of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente, Philips Research Eindhoven
- Responsible party
- Sponsor
- Investigators
- C.M.J. Doggen, prof. dr., Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501314
- Sponsor's protocol ID
- NL81630.091.22
- Acronym
- REMAP
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Home Monitoring of Patients With a Predicted Mild Acute Pancreatitis - A Feasibility Study (REMAP)
- ClinicalTrials.gov ID
- NCT05501314
- Acronym / sponsor ID
- REMAP / NL81630.091.22
- Conditions
- Acute Pancreatitis, Telemedicine, Healthdot, Patient Discharge, Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- University of Twente, Philips Research Eindhoven
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| Early discharge with remote home monitoring. | Experimental | Other: Early discharge with remote home monitoring.* Patients are discharged early * Patients receive remote home monitoring using a wearable sensor and a smartphone app. * Patients fill in a satisfaction questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have 2 out of 3 revised Atlanta criteria for pancreatitis:
- 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).
Key exclusion criteria (21 listed)
- Chronic pancreatitis according to M-ANNHEIM criteria (20).
- Signs of severe pancreatitis at the moment of admission to the GE ward:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. 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. | Other | Early discharge with remote home monitoring. |
Primary outcome
Incidence (%) of unplanned hospital readmissions.
Time frame: Within 30 days of discharge
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.
Time frame: Within 30 days of discharge
To determine the feasibility of novel care pathway
3. Mortality (%) of patients discharged home with remote monitoring.
Time frame: Within 30 days of discharge
To determine the feasibility of novel care pathway
4 secondary outcomes
Length of stay in the hospital
Time frame: 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.
Time frame: Within 30 days of discharge
The amount of laboratory or imaging tests
Time frame: Within 30 days of discharge
Amount of adjustments in analgesics needed during home monitoring
Time frame: Within 30 days of discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C.M.J. Doggen, prof. dr. principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early discharge with remote home monitoring. in people with Acute Pancreatitis and Telemedicine, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact C.M.J. Doggen, prof. dr. (+31880056042, REMAPstudy@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (%) of unplanned hospital readmissions. (time frame: Within 30 days of discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.