Early Discharge - Evaluating a Virtual Hospital at Home Model

NCT05920304 | Completed DMC

• 1 other identifier: Influenz-er 2
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

This controlled clinical trial will be part of a larger, 'virtual hospital-at-home' (vHaH) project called Influenz-er. vHaH is a care model designed to deliver medical care at home, as a substitute for a continued conventional inpatient hospital admission. The overall aim of Influenz-er is to develop, implement and evaluate a novel Hospital at Home model, that will enable safe and satisfactory admission of hospitalised patients including epidemic patients in their homes.

Conditions

Epidemic Disease; Infections

Keywords

Telemedicine; Hospital at Home

Outcome Measures

Primary Outcomes (7)

• Physical activity level

  Daily step count and time in different activity levels will be measured using an accelerometer placed on the thigh of the participant.

  Will be measured during admission (home-based vs. hospital), an average of 5 days after study enrollment

• Patient mental wellbeing (quantitative)

  Evaluation through questionnaires

  14 days post discharge

• Patient mental wellbeing (qualitative)

  Evaluation through semi-structured interviews

  14 days post discharge

• Patient satisfaction (quantitative)

  Evaluation through questionnaires

  14 days post discharge

• Patient satisfaction (qualitative)

  Evaluation through semi-structured interviews

  14 days post discharge

• Patient perceived safety (quantitative)

  Evaluation through questionnaires

  14 days post discharge

• Patient perceived safety (qualitative)

  Evaluation through semi-structured interviews

  14 days post discharge

Secondary Outcomes (18)

• Demographic characterisation of patients eligible for vHaH

  14 days post discharge

• Rate of adverse events of special interest (AESI)

  Immediately after discharge

• Readmittance rate post discharge (30 days and 90 days)

  30 and 90 days post discharge

• Mortality during admission

  daily registration during hospital admission or home-based admission, an average of 5 days after study enrollment

• Mortality post-discharge (7 days, 30 days, and 90 days)

  7, 30 and 90 days post discharge

Study Arms (2)

virtual Hospital at Home (vHaH)

EXPERIMENTAL

Participants are transferred home for telemedicine supported home-based admission.

Device: virtual Hospital at Home (vHaH)

Continued conventional hospitalisation

NO INTERVENTION

Participants will follow a conventional hospital admission.

Interventions

virtual Hospital at Home (vHaH) DEVICE

Participants randomized to vHaH will transferred home for home-based admission. Participants will be provided with equipment for self-monitoring (respiratory rate, oxygen saturation, blood pressure, heart rate and temperature). They will receive an app on their smartphone or tablet for transferring of self-measurements and communication with the hospital during their home-based admission. Supporting the telemedicine concept, a mobile hospital-based care team will perform clinical tasks including intravenous administration, blood samples and on-site clinical assessment in the participant's home, when relevant. Daily ward rounds will be conducted as video consultations. Before leaving the hospital, participants will receive thorough education on how to self-monitor and how to use the app.

Also known as: mit e-hospital

virtual Hospital at Home (vHaH)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Patients admitted to
• the Department of Pulmonary and Infectious Diseases (DPID) under any diagnosis or
• to the Department of Multimorbidity under any diagnosis
• Residential address within the catchment area of North Zealand University Hospital
• Treatment regimen which can be handled within the vHaH model

You may not qualify if:

• Unstable clinical condition defined by a current early warning score (EWS) \> 6 or single score = 3.
• Permanent physical or cognitive impairment or observed non-compliance that might negatively affect the ability to perform any of the required actions during the intervention such as self-measurements, data transfer by the app, and/or communication via telephone or video consultation.
• a. This may include, but is not limited to conditions such as dementia, post-stroke sequelae, deafness, extreme tremor of the upper limbs.
• Unproficiency in Danish language skills
• Pregnancy

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Innovation Fund Denmark: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (1)

• Larsen MN, Dreisig TS, Rasmussen MK, Christensen ML, Bjerregaard D, von Sydow CD, Nielsen TL, Fischer TK. Telemedicine-supported hospital-at-home for acutely admitted patients at Nordsjaellands Hospital, Denmark: a study protocol for a randomised controlled trial. BMJ Open. 2025 May 14;15(5):e098287. doi: 10.1136/bmjopen-2024-098287.

  PMID: 40374231 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Christian S Skjoldvang, MD

  Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital

  PRINCIPAL INVESTIGATOR

• Miljena Copois, MD

  Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking of participants is not possible due to the nature of the study
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized clinical trial. Participants will be randomized in the ratio 1:2 (for each participant randomized to vHaH, there will be two participants randomized to continued conventional in-hospital admission)

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 27, 2023
• Study Start: June 1, 2023
• Primary Completion: January 20, 2025
• Study Completion: May 20, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 5 years from study onset
• Access Criteria: Data will be stored in the database management system, REDCap, where certain researchers can access data.

Locations

DK (1)