Epidemic DiseaseNCT05920304
Early Discharge - Evaluating a Virtual Hospital at Home Model
A study testing virtual Hospital at Home (vHaH) in people with Epidemic Disease and Infections, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Epidemic Disease, Infections
- What is being tested?
- virtual Hospital at Home (vHaH)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2023to 20 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
Hillerød, 3400
About this study
Official title: Early Discharge - a Randomised Controlled Trial Evaluating Mental and Physical Effects on Acutely and Chronically Ill Patients in a Telemedicine Supported Virtual Hospital at Home Model
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.
Read the detailed description
Various versions of hospital-at-home models have been implemented as an emergency solution to a steep increase in number of hospitalisations during the COVID-19 pandemic crisis. Conventionally, epidemic patients who require medical monitoring, will be admitted to the hospital. Recently, patients hospitalised for COVID-19 requiring medical supervision for an extended period - sometimes for weeks - have been admitted to their own home supported by telemedicine and/or mobile hospital-based care team (MHCT). Various models of home-based admissions of pandemic patients have been implemented internationally with great results regarding safety and effectiveness. These models are mostly based on physical attendance of physicians in the patient's home and in most situations implemented out of need. Home-based models provide promising results regarding costs, but results are based on low-quality evidence. Health systems facing capacity constraints and rising costs needs to allocate resources based on high-quality evidence.
Therefore, further research regarding feasibility, safety, satisfaction, costs, and effectiveness of a vHaH model still needs to be done.
Danish hospital capacity will not allow for HaH models primarily depending on physical attendance of physicians in the patient's home, nor will it be possible to manually monitor all patient reported data. Therefore, there is a need for a telemedicine supported vHaH model with a smart algorithm alarming clinical staff and thereby aiding in timely handling of patient data and clinical state.
Project Influenz-er proposes an option of transfer to telemedicine supported vHaH model as an alternative to continued standard hospital admission for the future. Patient safety is a top priority regarding both the utilised technology and the re-organisation of standard clinical responsibilities and tasks. Therefore, project Influenz-er included several steps prior to the effectiveness evaluation in this clinical trial.
In the present study, knowledge from previous studies under project Influenz-er is applied, and the vHaH is now ready to be evaluated in an effectiveness trial.
- Conditions
- Epidemic Disease, Infections
- Being tested
- virtual Hospital at Home (vHaH)
- Keywords
- Telemedicine, Hospital at Home
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual Hospital at Home (vHaH)Device
Also called mit e-hospital
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.
| Study group | Role | What they receive |
|---|---|---|
| virtual Hospital at Home (vHaH) | Experimental | Participants are transferred home for telemedicine supported home-based admission. Receives: Device: virtual Hospital at Home (vHaH) |
| Continued conventional hospitalisation | No intervention | Participants will follow a conventional hospital admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Will be measured during admission (home-based vs. hospital), an average of 5 days after study enrollment
Patient mental wellbeing (quantitative)
Evaluation through questionnaires
Measured: 14 days post discharge
Patient mental wellbeing (qualitative)
Evaluation through semi-structured interviews
Measured: 14 days post discharge
Patient satisfaction (quantitative)
Evaluation through questionnaires
Measured: 14 days post discharge
Patient satisfaction (qualitative)
Evaluation through semi-structured interviews
Measured: 14 days post discharge
Patient perceived safety (quantitative)
Evaluation through questionnaires
Measured: 14 days post discharge
Patient perceived safety (qualitative)
Evaluation through semi-structured interviews
Measured: 14 days post discharge
Secondary outcomes (18)
Demographic characterisation of patients eligible for vHaH
Evaluation through questionnaires
Measured: 14 days post discharge
Rate of adverse events of special interest (AESI)
Evaluation through patient record data
Measured: Immediately after discharge
Readmittance rate post discharge (30 days and 90 days)
Evaluation through patient record data
Measured: 30 and 90 days post discharge
Mortality during admission
Evaluation through patient record data
Measured: 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)
Evaluation through patient record data
Measured: 7, 30 and 90 days post discharge
Percentage of timely service delivery in response to red alarms as a sign of clinical deterioration (health workers demonstrate adequate ability in telemedicine service delivery).
Data will be extracted from patient-monitoring platform "mit e-hospital" and patient record data
Measured: daily registration during home-based admission, an average of 5 days after study enrollment
Percentage of scheduled video consultation which were delivered
Data will be extracted from patient-monitoring platform "mit e-hospital" and patient record data
Measured: daily registration during home-based admission, an average of 5 days after study enrollment
Number of patient app deficiencies for participants enrolled in intervention arm
Data will be extracted from patient record data
Measured: daily registration during home-based admission, an average of 5 days after study enrollment
Number of health care provider dashboard deficiencies
Data will be extracted from patient record data
Measured: daily registration during home-based admission, an average of 5 days after study enrollment
Costs related to initiation of home-based admission
Economic endpoint
Measured: three months post discharge
Number of in-hospital days
Economic endpoint
Measured: three months post discharge
Number of outpatient visits
Economic endpoint
Measured: three months post discharge
Costs of hospital resource use
Economic endpoint
Measured: three months post discharge
Number of contacts in primary care (general practitioner, physiotherapy etc.)
Economic endpoint
Measured: three months post discharge
Costs of primary care resource use
Economic endpoint
Measured: three months post discharge
Total costs of health care utilisation per patient
Economic endpoint
Measured: three months post discharge
Health-related Quality of Life
Economic endpoint, evaluated using questionnaire EQ-5D-5L (EuroQol, 5 dimensions, 5 levels questionnaire).
On a scale 1 to 5, a score of 1 indicates the best health state, and higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status.
Measured: three months post discharge
Productivity losses (resources lost when participants work at suboptimal levels or are absent from work)
Economic endpoint
Measured: three months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jun 2023
- Primary completion20 Jan 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epidemic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark, University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Christian S Skjoldvang, MD, Principal investigator, Department of Pulmonary and Infectious Diseases, Nordsjællands HospitalMiljena Copois, MD, Principal investigator, Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920304
- Sponsor's protocol ID
- Influenz-er 2
- Status last verified
- May 2025
- First submitted
- 26 May 2023
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Personally identifiable data will be shared with researcher at University of Southern Denmark in accordance with our "data processing agreement" approved by lawyers of the Capital Region of Denmark.
Publications
Larsen MN, Dreisig TS, Rasmussen MK, Demuth von Sydow C, Nielsen TL, Christensen ML, Copois M, Roed C, Lange T, Fischer TK. Hybrid Hospital at Home and Physical Activity for Adults Admitted to the Hospital With Acute Illness: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2618812. doi: 10.1001/jamanetworkopen.2026.18812.
PubMed 42329654Larsen 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.
PubMed 40374231
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Discharge - a Randomised Controlled Trial Evaluating Mental and Physical Effects on Acutely and Chronically Ill Patients in a Telemedicine Supported Virtual Hospital at Home Model
- ClinicalTrials.gov ID
- NCT05920304
- Acronym / sponsor ID
- Influenz-er 2
- Conditions
- Epidemic Disease, Infections
- Keywords
- Telemedicine, Hospital at Home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark, University of Southern Denmark
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Various versions of hospital-at-home models have been implemented as an emergency solution to a steep increase in number of hospitalisations during the COVID-19 pandemic crisis. Conventionally, epidemic patients who require medical monitoring, will be admitted to the hospital. Recently, patients hospitalised for COVID-19 requiring medical supervision for an extended period - sometimes for weeks - have been admitted to their own home supported by telemedicine and/or mobile hospital-based care team (MHCT). Various models of home-based admissions of pandemic patients have been implemented internationally with great results regarding safety and effectiveness. These models are mostly based on physical attendance of physicians in the patient's home and in most situations implemented out of need. Home-based models provide promising results regarding costs, but results are based on low-quality evidence. Health systems facing capacity constraints and rising costs needs to allocate resources based on high-quality evidence.
Therefore, further research regarding feasibility, safety, satisfaction, costs, and effectiveness of a vHaH model still needs to be done.
Danish hospital capacity will not allow for HaH models primarily depending on physical attendance of physicians in the patient's home, nor will it be possible to manually monitor all patient reported data. Therefore, there is a need for a telemedicine supported vHaH model with a smart algorithm alarming clinical staff and thereby aiding in timely handling of patient data and clinical state.
Project Influenz-er proposes an option of transfer to telemedicine supported vHaH model as an alternative to continued standard hospital admission for the future. Patient safety is a top priority regarding both the utilised technology and the re-organisation of standard clinical responsibilities and tasks. Therefore, project Influenz-er included several steps prior to the effectiveness evaluation in this clinical trial.
In the present study, knowledge from previous studies under project Influenz-er is applied, and the vHaH is now ready to be evaluated in an effectiveness trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| virtual Hospital at Home (vHaH) | Experimental | Device: virtual Hospital at Home (vHaH)Participants are transferred home for telemedicine supported home-based admission. |
| Continued conventional hospitalisation | No intervention | –Participants will follow a conventional hospital admission. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Patients admitted to
- Residential address within the catchment area of North Zealand University Hospital
- Treatment regimen which can be handled within the vHaH model
Key exclusion criteria (5 listed)
- 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.
- Unproficiency in Danish language skills
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual Hospital at Home (vHaH)Also: mit e-hospitalParticipants 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. | Device | virtual Hospital at Home (vHaH) |
Primary outcome
Physical activity level
Time frame: Will be measured during admission (home-based vs. hospital), an average of 5 days after study enrollment
Daily step count and time in different activity levels will be measured using an accelerometer placed on the thigh of the participant.
Patient mental wellbeing (quantitative)
Time frame: 14 days post discharge
Evaluation through questionnaires
Patient mental wellbeing (qualitative)
Time frame: 14 days post discharge
Evaluation through semi-structured interviews
Patient satisfaction (quantitative)
Time frame: 14 days post discharge
Evaluation through questionnaires
Patient satisfaction (qualitative)
Time frame: 14 days post discharge
Evaluation through semi-structured interviews
Patient perceived safety (quantitative)
Time frame: 14 days post discharge
Evaluation through questionnaires
Patient perceived safety (qualitative)
Time frame: 14 days post discharge
Evaluation through semi-structured interviews
18 secondary outcomes
Demographic characterisation of patients eligible for vHaH
Time frame: 14 days post discharge
Rate of adverse events of special interest (AESI)
Time frame: Immediately after discharge
Readmittance rate post discharge (30 days and 90 days)
Time frame: 30 and 90 days post discharge
Mortality during admission
Time frame: 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)
Time frame: 7, 30 and 90 days post discharge
Percentage of timely service delivery in response to red alarms as a sign of clinical deterioration (health workers demonstrate adequate ability in telemedicine service delivery).
Time frame: daily registration during home-based admission, an average of 5 days after study enrollment
Percentage of scheduled video consultation which were delivered
Time frame: daily registration during home-based admission, an average of 5 days after study enrollment
Number of patient app deficiencies for participants enrolled in intervention arm
Time frame: daily registration during home-based admission, an average of 5 days after study enrollment
Number of health care provider dashboard deficiencies
Time frame: daily registration during home-based admission, an average of 5 days after study enrollment
Costs related to initiation of home-based admission
Time frame: three months post discharge
Number of in-hospital days
Time frame: three months post discharge
Number of outpatient visits
Time frame: three months post discharge
Costs of hospital resource use
Time frame: three months post discharge
Number of contacts in primary care (general practitioner, physiotherapy etc.)
Time frame: three months post discharge
Costs of primary care resource use
Time frame: three months post discharge
Total costs of health care utilisation per patient
Time frame: three months post discharge
Health-related Quality of Life
Time frame: three months post discharge
Productivity losses (resources lost when participants work at suboptimal levels or are absent from work)
Time frame: three months post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Derived from this study: PubMed 42329654Larsen MN, Dreisig TS, Rasmussen MK, Demuth von Sydow C, Nielsen TL, Christensen ML, Copois M, Roed C, Lange T, Fischer TK. Hybrid Hospital at Home and Physical Activity for Adults Admitted to the Hospital With Acute Illness: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2618812. doi: 10.1001/jamanetworkopen.2026.18812.
- Derived from this study: PubMed 40374231Larsen 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.
- Individual participant dataSharing planned: Yes. Personally identifiable data will be shared with researcher at University of Southern Denmark in accordance with our "data processing agreement" approved by lawyers of the Capital Region of Denmark.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian S Skjoldvang, MD principal investigator
Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
Miljena Copois, MD principal investigator
Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual Hospital at Home (vHaH) in people with Epidemic Disease and Infections, run by Nordsjaellands Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (time frame: Will be measured during admission (home-based vs. hospital), an average of 5 days after study enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920304, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.