Pancreatitis, AcuteINTERACTNCT06178172
Remote Home Monitoring in Mild Acute Pancreatitis
A study testing Remote home monitoring in people with Pancreatitis, Acute and Remote Home Monitoring, run by Rijnstate Hospital at 2 sites 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 patients with a mild acute pancreatitis is mostly supportive, providing this care in the home environment may be feasible… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Acute, Remote Home Monitoring, Early Discharge
- What is being tested?
- Remote home monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesNetherlands
- Study dates
- 2 Jan 2024to 2 Oct 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
- 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
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- 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
Who cannot join
- 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
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- 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
2 sites in 1 country.
Netherlands2 sites
Rijnstate Hospital
Arnhem, Gelderland, 6815 AD
Rijnstate Hospital
Arnhem
C.J.M. Doggen, prof.dr., 0880556042, cdoggen@rijnstate.nl
About this study
Official title: Implementation of a Remote Home Monitoring Program for Patients With a Mild Acute Pancreatitis - A Single Center Feasibility Study
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.
- Conditions
- Pancreatitis, Acute, Remote Home Monitoring, Early Discharge
- Being tested
- 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.
Remote home monitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early discharge with remote home monitoring. | Experimental | 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. Receives: Other: Remote home monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with overall care, based on satisfaction questionnaire
Overall care from GE-ward admittance until discontinuation of remote home monitoring.
Measured: Within 30 days of hospital admission
Patient satisfaction with smartphone app (Luscii), based on satisfaction questionnaire
Measured: Within 30 days of hospital admission
Patient satisfaction with wearable sensor (Healthdot), based on satisfaction questionnaire
Measured: Within 30 days of hospital admission
Patient intent to participate in the care program again
Based on satisfaction questionnaire
Measured: Within 30 days of hospital admission
Proportion of patients willing and able to participate
Measured: Within 30 days of hospital admission
Time between discharge decision and actual hospital discharge in days
Measured: Within 30 days of hospital admission
Duration of remote home monitoring in days
Measured: Within 30 days of hospital admission
Number of contacts between patients and healthcare professionals
Measured: Within 30 days of hospital admission
Number of additional laboratory tests (during home monitoring)
Measured: Within 30 days of hospital admission
Smartphone app functionality, determined by generated notifications, time between notification and contact with VMC-nurse and questionnaire compliance
Measured: Within 30 days of hospital admission
Wearable sensor functionality, determined by the amount of missing data and accidental detachments
Measured: Within 30 days of hospital admission
Secondary outcomes (8)
Use of analgesics and anti-emetics, described as the number of days used
Measured: Within 30 days of hospital admission
Pain scores, based on NRS (0-10)
Measured: Within 30 days of hospital admission
Intake of food and fluids, described as number of meals and liters of fluid intake
Measured: Within 30 days of hospital admission
Activity levels, as measured by the wearable sensor (0-10)
Measured: Within 30 days of hospital admission
Time between GE ward admission and discharge decision in days
Measured: Within 30 days of hospital admission
Hospital readmissions
Measured: Within 30 days of hospital admission
Emergency department (ED) revisits
An ED revisit followed by a hospital readmission will be documented as a hospital readmission
Measured: Within 30 days of hospital admission
Pancreatitis-related complications
Pseudocysts, necrosis, etc.
Measured: Within 30 days of hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start2 Jan 2024 (estimated)
- Primary completion2 Jun 2025 (estimated)
- Study completion2 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, AcuteStudies 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
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178172
- Sponsor's protocol ID
- NL84869.100.23
- Acronym
- INTERACT
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Remote Home Monitoring Program for Patients With a Mild Acute Pancreatitis - A Single Center Feasibility Study
- ClinicalTrials.gov ID
- NCT06178172
- Acronym / sponsor ID
- INTERACT / NL84869.100.23
- Conditions
- Pancreatitis, Acute, Remote Home Monitoring, Early Discharge
- 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
- 2 Jan 2024 (estimated)
- Primary completion
- 2 Jun 2025 (estimated)
- Study completion
- 2 Oct 2025 (estimated)
- First posted
- 20 Dec 2023 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early discharge with remote home monitoring. | Experimental | Other: Remote home monitoringAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Acute pancreatitis according to the revised Atlanta criteria for pancreatitis(23). Which is at least 2 of the following 3 criteria:
- 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)
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Remote home monitoringAfter 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. | Other | Early discharge with remote home monitoring. |
Primary outcome
Patient satisfaction with overall care, based on satisfaction questionnaire
Time frame: Within 30 days of hospital admission
Overall care from GE-ward admittance until discontinuation of remote home monitoring.
Patient satisfaction with smartphone app (Luscii), based on satisfaction questionnaire
Time frame: Within 30 days of hospital admission
Patient satisfaction with wearable sensor (Healthdot), based on satisfaction questionnaire
Time frame: Within 30 days of hospital admission
Patient intent to participate in the care program again
Time frame: Within 30 days of hospital admission
Based on satisfaction questionnaire
Proportion of patients willing and able to participate
Time frame: Within 30 days of hospital admission
Time between discharge decision and actual hospital discharge in days
Time frame: Within 30 days of hospital admission
Duration of remote home monitoring in days
Time frame: Within 30 days of hospital admission
Number of contacts between patients and healthcare professionals
Time frame: Within 30 days of hospital admission
Number of additional laboratory tests (during home monitoring)
Time frame: Within 30 days of hospital admission
Smartphone app functionality, determined by generated notifications, time between notification and contact with VMC-nurse and questionnaire compliance
Time frame: Within 30 days of hospital admission
Wearable sensor functionality, determined by the amount of missing data and accidental detachments
Time frame: Within 30 days of hospital admission
8 secondary outcomes
Use of analgesics and anti-emetics, described as the number of days used
Time frame: Within 30 days of hospital admission
Pain scores, based on NRS (0-10)
Time frame: Within 30 days of hospital admission
Intake of food and fluids, described as number of meals and liters of fluid intake
Time frame: Within 30 days of hospital admission
Activity levels, as measured by the wearable sensor (0-10)
Time frame: Within 30 days of hospital admission
Time between GE ward admission and discharge decision in days
Time frame: Within 30 days of hospital admission
Hospital readmissions
Time frame: Within 30 days of hospital admission
Emergency department (ED) revisits
Time frame: Within 30 days of hospital admission
Pancreatitis-related complications
Time frame: Within 30 days of hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: Undecided. Data available upon reasonable request.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote home monitoring in people with Pancreatitis, Acute and Remote Home Monitoring, run by Rijnstate Hospital at 2 sites 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 18 inclusion and 15 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 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction with overall care, based on satisfaction questionnaire (time frame: Within 30 days of hospital admission). The study lists 11 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 20 Dec 2023.