2015-04
2016-08
2016-09
90
NCT02933307
Radboud University Medical Center
Radboud University Medical Center
INTERVENTIONAL
Continuous Monitoring on the General Ward
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2016-07-25 | N/A | 2017-04-24 |
2016-10-13 | N/A | 2017-04-25 |
2016-10-14 | N/A | 2016-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
NO_INTERVENTION: Control group Patients with regular measurements by nurses only (Modified Early Warning Score (MEWS)) | |
EXPERIMENTAL: HealthPatch (Intervention) Patients with HealthPatch and regular MEWS measurements | DEVICE: HealthPatch
|
EXPERIMENTAL: ViSi Mobile (Intervention) Patients with ViSi Mobile and regular MEWS measurements | DEVICE: ViSi Mobile
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Expectations & experiences of patients | Interviews of 15-20 minutes with patients after 2-3 days wearing a device or control group | 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 | 1 year |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
MEWS scores based on continuous data and data measured by nurses | 3 times a day, up to three days. | |
Amount of alarms by HealthPatch or ViSi Mobile | during 2-3 days when the patient wears a device | |
Time between alarm (continuous data) and next regular MEWS measurement (nurse) | during 2-3 days when the patient wears a device | |
Amount of extra MEWS measurements by nurses due to alarms | during 2-3 days when the patient wears a device | |
Admission to ICU (yes/no) | during 2-3 days when the patient participates in this study | |
Duration of ICU hospitalization in days | during 2-3 days when the patient participates in this study | |
Complications caused by disease or surgical procedure | during 2-3 days when the patient participates in this study | |
Adverse events caused by devices | E.g. Itch or redness | 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) | during 2-3 days when the patient wears a device | |
Outcomes of the State Trait Anxiety Inventory (STAI) | Once a day during the 2-3 days the patient participantes in this study | |
Outcomes of the Pain Catastrophizing Scale (PCS) | On day 2 or 3 when patients participates in the study | |
System usability Scale | 1 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications