Carcinoma, Pancreatic DuctalNCT02933307
Continuous Monitoring on the General Ward
A study testing HealthPatch and ViSi Mobile in people with Carcinoma, Pancreatic Ductal and Colorectal Neoplasms, run by Radboud University Medical Center.
Trial summary
Rationale: Monitoring patients' vital signs is done to detect clinical deterioration. For this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is used. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carcinoma, Pancreatic Ductal, Colorectal Neoplasms, Arthritis
- What is being tested?
- HealthPatch and ViSi Mobile
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Sep 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18 years or older on the day the informed consent will be signed.
- Patient is hospitalized on the surgical or internal medicine ward.
- MEWS measurements are required at least three times a day.
- Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
Who cannot join
- Frequency of MEWS measurements is less than three times a day.
About this study
Official title: Continuous Monitoring of Vital Signs in Hospitalized Patients
Rationale: Monitoring patients' vital signs is done to detect clinical deterioration. For this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is used. Although the MEWS provides relevant data on patients' health status, the interval measurements may not capture early deterioration of vital signs, especially during the night. As a result, unsafe situations may occur such as periods of low oxygen saturation and cardiac arrhythmias, which are known to complicate postoperative course. Besides, this way of measuring vital signs may be stressful for patients and disturbs patients' sleep. New technology such as ViSi Mobile and HealthPatch allows for remote continuous monitoring of vital signs using wearable devices transmitting relevant data to nurses and clinicians. With this, the investigators think that clinical deterioration may be detected in an early phase and reduce nurse work load and patient distress.
Objective: to investigate the feasibility of wearable devices on the general ward.
Read more
Study design: feasibility study.
Study population: adult patients hospitalized on the internal medicine ward and adult postoperative patients on the surgical ward.
Intervention: patients in the intervention groups will be randomized in one of the two groups. Patients in the group 1 will wear ViSi Mobile; patients in group 2 will wear the HealthPatch. Wearable devices will be worn for at least three days. Regular MEWS measurements take place at usual time points.
Main study parameters/endpoints: Evaluation with patient and care givers (primary outcome measure), MEWS calculations, time between alarm (continuous data) and next regular MEWS measurement (nurse), intervention by nurse after alarm, admission to ICU, complications, side effects of devices, STAI scores, and PCS scores will be documented.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will wear one device for at least three days. Devices can be uncomfortable by being heavy or the patches can start itching. More measurements by nurses can take place when indicated, for example after alarms. The participating patients will fill out the STAI on daily basis and the PCS on the last day of hospitalization. Both questionnaires will take a few minutes to complete. Patients could benefit from early detection of clinical deterioration and early corrective interventions or ICU admissions.
- Being tested
- HealthPatch, ViSi Mobile
- Medical subject headings
- Carcinoma, Pancreatic Ductal, Colorectal Neoplasms, Arthritis, Hypertension, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthPatchDevice
The HealthPatch (Vital Connect) is a wireless patch and continuously measures single-lead ECG, heart rate, respiratory rate, stress, skin temperature, body posture and steps
ViSi MobileDevice
ViSi Mobile (Sotera Wireless) is wireless device that is able to continuously measure all important vital parameters: ECG, heart rate, oxygen saturation, blood pressure, respiratory rate and skin temperature.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients with regular measurements by nurses only (Modified Early Warning Score (MEWS)) |
| HealthPatch (Intervention) | Experimental | Patients with HealthPatch and regular MEWS measurements Receives: Device: HealthPatch |
| ViSi Mobile (Intervention) | Experimental | Patients with ViSi Mobile and regular MEWS measurements Receives: Device: ViSi Mobile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expectations & experiences of patients
Interviews of 15-20 minutes with patients after 2-3 days wearing a device or control group
Measured: 2-3 days after informed consent
Expectations & experiences of care givers
Interviews with nurses of 15-20 minutes at the end of the study. Estimated amount of 6 nurses
Measured: 1 year
Secondary outcomes (12)
MEWS scores based on continuous data and data measured by nurses
Measured: 3 times a day, up to three days.
Amount of alarms by HealthPatch or ViSi Mobile
Measured: during 2-3 days when the patient wears a device
Time between alarm (continuous data) and next regular MEWS measurement (nurse)
Measured: during 2-3 days when the patient wears a device
Amount of extra MEWS measurements by nurses due to alarms
Measured: during 2-3 days when the patient wears a device
Admission to ICU (yes/no)
Measured: during 2-3 days when the patient participates in this study
Duration of ICU hospitalization in days
Measured: during 2-3 days when the patient participates in this study
Complications caused by disease or surgical procedure
Measured: during 2-3 days when the patient participates in this study
Adverse events caused by devices
E.g. Itch or redness
Measured: during 2-3 days when the patient wears a device
Technical failures of devices (artifacts: a period longer than 1 minute the device does not measure vital parameters)
Measured: during 2-3 days when the patient wears a device
Outcomes of the State Trait Anxiety Inventory (STAI)
Measured: Once a day during the 2-3 days the patient participantes in this study
Outcomes of the Pain Catastrophizing Scale (PCS)
Measured: On day 2 or 3 when patients participates in the study
System usability Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startApr 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Pancreatic DuctalStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry van Goor, MD, PhD, FRCS, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933307
- Sponsor's protocol ID
- HEEL-2015-03
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2016
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Weenk M, Bredie SJ, Koeneman M, Hesselink G, van Goor H, van de Belt TH. Continuous Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized Controlled Trial. J Med Internet Res. 2020 Jun 10;22(6):e15471. doi: 10.2196/15471.
PubMed 32519972
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of Vital Signs in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT02933307
- Acronym / sponsor ID
- HEEL-2015-03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Oct 2016 (estimated)
- 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.
Rationale: Monitoring patients' vital signs is done to detect clinical deterioration. For this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is used. Although the MEWS provides relevant data on patients' health status, the interval measurements may not capture early deterioration of vital signs, especially during the night. As a result, unsafe situations may occur such as periods of low oxygen saturation and cardiac arrhythmias, which are known to complicate postoperative course. Besides, this way of measuring vital signs may be stressful for patients and disturbs patients' sleep. New technology such as ViSi Mobile and HealthPatch allows for remote continuous monitoring of vital signs using wearable devices transmitting relevant data to nurses and clinicians. With this, the investigators think that clinical deterioration may be detected in an early phase and reduce nurse work load and patient distress.
Objective: to investigate the feasibility of wearable devices on the general ward.
Study design: feasibility study.
Study population: adult patients hospitalized on the internal medicine ward and adult postoperative patients on the surgical ward.
Intervention: patients in the intervention groups will be randomized in one of the two groups. Patients in the group 1 will wear ViSi Mobile; patients in group 2 will wear the HealthPatch. Wearable devices will be worn for at least three days. Regular MEWS measurements take place at usual time points.
Main study parameters/endpoints: Evaluation with patient and care givers (primary outcome measure), MEWS calculations, time between alarm (continuous data) and next regular MEWS measurement (nurse), intervention by nurse after alarm, admission to ICU, complications, side effects of devices, STAI scores, and PCS scores will be documented.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will wear one device for at least three days. Devices can be uncomfortable by being heavy or the patches can start itching. More measurements by nurses can take place when indicated, for example after alarms. The participating patients will fill out the STAI on daily basis and the PCS on the last day of hospitalization. Both questionnaires will take a few minutes to complete. Patients could benefit from early detection of clinical deterioration and early corrective interventions or ICU admissions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients with regular measurements by nurses only (Modified Early Warning Score (MEWS)) |
| HealthPatch (Intervention) | Experimental | Device: HealthPatchPatients with HealthPatch and regular MEWS measurements |
| ViSi Mobile (Intervention) | Experimental | Device: ViSi MobilePatients with ViSi Mobile and regular MEWS measurements |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is 18 years or older on the day the informed consent will be signed.
- Patient is hospitalized on the surgical or internal medicine ward.
- MEWS measurements are required at least three times a day.
- Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
Key exclusion criteria (1 listed)
- Frequency of MEWS measurements is less than three times a day.
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 |
|---|---|---|
| HealthPatchThe HealthPatch (Vital Connect) is a wireless patch and continuously measures single-lead ECG, heart rate, respiratory rate, stress, skin temperature, body posture and steps | Device | HealthPatch (Intervention) |
| ViSi MobileViSi Mobile (Sotera Wireless) is wireless device that is able to continuously measure all important vital parameters: ECG, heart rate, oxygen saturation, blood pressure, respiratory rate and skin temperature. | Device | ViSi Mobile (Intervention) |
Primary outcome
Expectations & experiences of patients
Time frame: 2-3 days after informed consent
Interviews of 15-20 minutes with patients after 2-3 days wearing a device or control group
Expectations & experiences of care givers
Time frame: 1 year
Interviews with nurses of 15-20 minutes at the end of the study. Estimated amount of 6 nurses
12 secondary outcomes
MEWS scores based on continuous data and data measured by nurses
Time frame: 3 times a day, up to three days.
Amount of alarms by HealthPatch or ViSi Mobile
Time frame: during 2-3 days when the patient wears a device
Time between alarm (continuous data) and next regular MEWS measurement (nurse)
Time frame: during 2-3 days when the patient wears a device
Amount of extra MEWS measurements by nurses due to alarms
Time frame: during 2-3 days when the patient wears a device
Admission to ICU (yes/no)
Time frame: during 2-3 days when the patient participates in this study
Duration of ICU hospitalization in days
Time frame: during 2-3 days when the patient participates in this study
Complications caused by disease or surgical procedure
Time frame: during 2-3 days when the patient participates in this study
Adverse events caused by devices
Time frame: during 2-3 days when the patient wears a device
Technical failures of devices (artifacts: a period longer than 1 minute the device does not measure vital parameters)
Time frame: during 2-3 days when the patient wears a device
Outcomes of the State Trait Anxiety Inventory (STAI)
Time frame: Once a day during the 2-3 days the patient participantes in this study
Outcomes of the Pain Catastrophizing Scale (PCS)
Time frame: On day 2 or 3 when patients participates in the study
System usability Scale
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Derived from this study: PubMed 32519972Weenk M, Bredie SJ, Koeneman M, Hesselink G, van Goor H, van de Belt TH. Continuous Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized Controlled Trial. J Med Internet Res. 2020 Jun 10;22(6):e15471. doi: 10.2196/15471.
- Individual participant dataSharing planned: No
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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.
Harry van Goor, MD, PhD, FRCS principal investigator
Radboud University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing HealthPatch and ViSi Mobile in people with Carcinoma, Pancreatic Ductal and Colorectal Neoplasms, run by Radboud University Medical Center.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expectations & experiences of patients (time frame: 2-3 days after informed consent). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02933307, which also lists 1 linked publication.
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 25 Apr 2017.