Surgical Ward Innovation: Telemonitoring Controlled by Healthdot

NCT05956210 | Unknown

• 1 other identifier: nWMO-2022.061
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This observational clinical, single center trial is designed to evaluate the implementation of an already validated smart monitoring device, the Philips Healthdot, on one surgical ward at the Catharina hospital in Eindhoven, The Netherlands. This study is performed during 6 months in which all patients admitted to one surgical ward will be enrolled. Implementation is established by a step-by-step approach in which the current manually performed spot check monitoring (blood pressure, oxygen saturation, respiratory rate, heart rate, temperature and pain score), with the early warning score (EWS), is continued besides smart monitoring with the Healthdot (respiratory rate, heart rate and physical activity) during the first three months (phase 1). This phase aims at optimizing the infrastructure, education of hospital staff and practice with application/ activation and interpretation of the device. Upward of 4 months, Healthdot monitoring will be the primary monitoring method and spot check monitoring is only performed additionally in case of doubt about clinical condition or requirement of additional vital parameters. Evaluation of the implementation will be performed with a focus group and various questionnaire regarding fidelity, acceptability, adoption, feasibility, appropriateness and costs. Thereby additional analysis regarding monitoring algorithms will be performed.

Conditions

Monitoring

Outcome Measures

Primary Outcomes (1)

• Evaluation of the implementation of a continuous monitoring method on the surgical ward

  Workload: the experienced workload for nursing staff during the implementation of the Healthdot measured with the IWS and during focus group analysis

  Conducted on a daily base during the entire study, month 1-6

Secondary Outcomes (8)

• Adoption

  3 focus groups sessions at month 3, 5 and 6

• Feasibility of the Healthdot

  3 focus groups sessions at month 3, 5 and 6

• Acceptability

  Evaluated at month 4 and 6

• Appropriateness

  Evaluated after at month 4 and 6

• Usability

  Evaluated after at month 4 and 6

Interventions

Evaluation of implementation regarding Philips Healthdot as monitoring device of hospitalized patients at one surgical ward DEVICE

Hospitalized patients at one surgical ward will receive a Healthdot as monitoring device which will be used as primary monitoring after 3 months of preparation with education of hospital staff, improving infrastructure and training with application, activation and interpretation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The main research population for answering the research objectives are the nurses and physicians working at the specific surgical ward at the Catharina hospital. In total around 500 adult patients, 250 during each phase, admitted to one surgical ward at the Catharina hospital will participate and receive a Healthdot. These patients will sign informed consent for use of anonymized data. This population differs in age, gender, admission cause, admission duration and comorbidities.

You may qualify if:

• Nurses
• Registered in the national register of medical professions (Big register)
• Appointed as a nurse at the Catharina hospital and working at the surgical department during the study period
• Willingness to participate in the core group for evaluation of the implementation
• Physicians
• Registered in the national register of medical professions (Big register)
• Appointed at the Catharina hospital as a physician or resident during the study period.
• Willingness to participate in the core group for evaluation of the implementation

You may not qualify if:

• Nurses \& Physicians
• Termination of employment within the study period
• No voluntarily participation in the core group evaluation meetings
• Contra-indications for applying Healthdot
• Known to have severe allergy for the tissue adhesive used in the Healthdot.
• Any skin condition, for example prior severe rash, discoloration, scars or open wounds at the area of application
• Pregnant, or breastfeeding
• Use of topicals that are known to irritate the skin at the application area (such as medical and non-medical creams or lotions)
• Patient with active implantable device such as a Implantable Cardiac Defibrillator (ICD) or pacemaker
• Unable to understand instructions
• Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
• Transfer to a different ward during hospitalization

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Philips Electronics Nederland B.V. acting through Philips CTO organization: collaborator

Study Sites (1)

Catharina hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

RECRUITING

Related Publications (1)

• Schonck F, Luyer M, van der Meer N, Bouwman A, Nienhuijs S. Implementation of a surgical ward innovation: Telemonitoring controlled by healthdot [SWITCH-trial PROTOCOL]. PLoS One. 2025 May 7;20(5):e0322472. doi: 10.1371/journal.pone.0322472. eCollection 2025.

  PMID: 40333921 DERIVED

Study Officials

• Friso Schonck

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Friso Schonck

CONTACT

+31629357105; friso.schonck@catharinaziekenhuis.nl

Simon Nienhuijs

CONTACT

003140 239 9111

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Docter (M.D.)

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: July 21, 2023
• Study Start: November 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)