NCT06936891

Brief Summary

This study evaluates the feasibility of providing hospital-level care at home for eligible patients through a Virtual Ward. Patients are discharged early from the hospital and monitored remotely using digital vital sign monitoring and anamnesis questionnaires. The primary aim is to determine if at least 30% of eligible patients can be safely and successfully transferred to the Virtual Ward under current Dutch healthcare conditions.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Apr 2025Dec 2028

First Submitted

Initial submission to the registry

April 13, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

April 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3.5 years

First QC Date

April 13, 2025

Last Update Submit

February 15, 2026

Conditions

Keywords

early dischargetelemedicinevirtual wardvirtual clinichospital at homefeasabilitytelemonitoring

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Successfully Transferred to the Virtual Ward After Providing Informed Consent

    Successful transfer is defined as discharge from hospital to the Virtual Ward with start of home monitoring according to care pathways. Threshold for feasibility is ≥30%.

    From enrollment to transfer to Virtual Ward (during hospitalization, up to 7 days)

Secondary Outcomes (10)

  • Number of Eligible Patients Invited for Participation

    From enrollment to invitation during hospitalization (up to 7 days)

  • Number of Invited Patients Providing Informed Consent

    From enrollment to signing informed consent during hospitalization (up to 7 days)

  • Time from Study Inclusion to Transfer to Virtual Ward

    From informed consent to Virtual Ward admission (up to 7 days)

  • Number of Notifications Generated During Virtual Ward Monitoring

    From Virtual Ward admission up to 30 days after discharge

  • Number of Contact Moments with Virtual Ward Staff

    From Virtual Ward admission up to 30 days after discharge

  • +5 more secondary outcomes

Other Outcomes (3)

  • Frailty Status Based on Clinical Frailty Scale and PRISMA-7 Questionnaire

    At enrollment (baseline)

  • Patient-Reported Experience of Virtual Ward Care

    Within 30 days after Virtual Ward discharge

  • Healthcare Provider-Reported Experience of Virtual Ward Care

    Approximately 6-12 months after study initiation

Study Arms (1)

Virtual Ward arm

EXPERIMENTAL

Patients receive hospital-level care at home via a Virtual Ward, including remote monitoring of vital signs, digital anamnesis questionnaires, and standard diagnostics and treatment, supported by telemonitoring staff and hospital physicians.

Combination Product: Virtual Ward

Interventions

Virtual WardCOMBINATION_PRODUCT

Hospital-level care at home using remote vital sign monitoring, digital anamnesis via the Digizorg app, and integration with the Electronic Medical Record (HiX), managed by Virtual Ward staff following predefined care pathways.

Virtual Ward arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (≥18 years old).
  • Currently hospitalized and eligible for early discharge according to clinical judgment.
  • Ability to provide written informed consent.
  • Access to a smartphone or tablet with internet connection.
  • Patient is capable of using the Digizorg app or has support from a caregiver who can assist.
  • Suitable home situation for Virtual Ward care (e.g., safe environment, necessary utilities available).
  • Enrollment in one of the predefined Virtual Ward care pathways

You may not qualify if:

  • Patients requiring continuous hospital-based monitoring or interventions that cannot be safely delivered at home.
  • Patients who are hemodynamically unstable or require oxygen therapy \>5 liters/minute at the time of discharge.
  • Patients unable or unwilling to comply with home monitoring procedures.
  • Patients with significant cognitive impairment without adequate caregiver support.
  • Patients with a life expectancy less than 30 days, as assessed by the treating physician.
  • Patients participating in another interventional clinical trial that could interfere with the Virtual Ward protocol.
  • Any other condition that, in the opinion of the treating physician, would make participation unsafe or infeasible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

Related Publications (1)

  • van Herwerden MC, Scholte NTB, Mkrtchjan A, Feyz L, Mol AP, Aitken J, de Boer RA, Chandoesing PP, Gommers DAMPJ, De Haan B, Den Hoed CM, van den Hoogen MWF, Peeters RP, Wlazlo N, Van Der Boon RMA, van De Weg CAM. Delivering hospital care at home in a Dutch Tertiary University Hospital: protocol for a prospective feasibility cohort study evaluating a Virtual Ward for early discharge of inpatients. BMJ Open. 2026 Feb 24;16(2):e115730. doi: 10.1136/bmjopen-2025-115730.

Study Officials

  • Cox van de Weg, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael C. van Herwerden, MD

CONTACT

Cox van de Weg, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: In this single-group study, patients eligible for early discharge are enrolled into a Virtual Ward model, providing hospital-level care at home. Care includes diagnostics (e.g., laboratory and urine testing) and treatment (e.g., intravenous antibiotics) equivalent to standard inpatient care, but administered in the home environment. Vital signs (oxygen saturation, respiratory rate, heart rate, blood pressure, weight, temperature) are monitored remotely three times daily via CE-marked devices and a secure mobile application (Digizorg), connected to the Zorgverlenerscockpit (Electronic Medical Record). Patients complete digital anamnesis questionnaires three times daily. Alerts for deviating vital signs or symptoms are handled by Virtual Ward staff, who verify measurements and escalate to the responsible physician if needed, according to predefined care pathways. Communication with patients and physicians follows standard clinical care protocols through (video) calls.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 13, 2025

First Posted

April 20, 2025

Study Start

April 16, 2025

Primary Completion (Estimated)

October 16, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations