RECRUITING

Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction.

Official Title

Alert Frequency, Nurse, and Patient Satisfaction With a Continuous Wireless Vital Sign Monitoring Software Across Health Care Systems and Cultures

Quick Facts

Study Start:2024-02-26
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06289699

Participation Criteria

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (≥18 years)
  2. * Expected stay in the hospital ≥2 days
  3. * Admitted for surgery with expected duration of surgery \>2 hours or admitted for acute medical condition with at least one of the following vital sign deviations within 24 hours of acute admission, recorded by the staff
  4. * RR \> 21 breaths pr minute
  5. * RR \< 11 breaths pr minute
  6. * Pulse (P) \> 91 beats pr minute
  7. * Pulse (P) \< 50 beats pr minute
  8. * SpO2 \< 94 % without oxygen supplementation
  9. * Systolic BP \< 110 mmHg
  10. * Systolic BP \> 220 mmHg
  1. * Participant expected not to cooperate with study procedures.
  2. * Allergy to plaster or silicone.
  3. * Pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
  4. * Inability to give informed consent.

Contacts and Locations

Study Contact

Katja K Head of Clinical, MD
CONTACT
004528781188
katja.groenbaek@ward247.com
Eske Kvanner Aasvang, MD
CONTACT
Eske.Kvanner.Aasvang.01@regionh.dk

Principal Investigator

Christian S Meyhoff, MD, PhD
PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark
Eske K Aasvang, MD, DMSci
PRINCIPAL_INVESTIGATOR
Rigshospitalet, Copenhagen University, Copenhagen, Denmark

Study Locations (Sites)

The Cleveland Clinic Foundation, General Anesthesiology
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Christian S. Meyhoff

  • Christian S Meyhoff, MD, PhD, PRINCIPAL_INVESTIGATOR, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark
  • Eske K Aasvang, MD, DMSci, PRINCIPAL_INVESTIGATOR, Rigshospitalet, Copenhagen University, Copenhagen, Denmark

Study Record Dates

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

Study Start Date2024-02-26
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-02-26
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • continuous wireless vital sign monitoring
  • vital sign deviation
  • healthcare system and culture
  • User Experience
  • Postoperative Complications
  • Acute Medical Conditions

Additional Relevant MeSH Terms

  • User Experience
  • Postoperative Complications
  • Acute Medical Conditions