Clinical Trial: Continuous Monitoring on the General Ward

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Continuous Monitoring of Vital Signs in Hospitalized Patients

Brief 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. 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), int

Detailed Summary:
Sponsor: Radboud University

Current 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    E.g. Itch or redness
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: July 25, 2016
Date Started: April 2015
Date Completion:
Last Updated: April 24, 2017
Last Verified: July 2016