Early Transfer of Hospitalized Patients Incl. COVID-19 to a Virtual Hospital at Home Model - a Clinical Feasibility Study

NCT05087082 | Completed DMC

• 1 other identifier: H-21014302
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study 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 in the home, as a substitute for a continued inpatient hospital admission. This study will be a clinical feasibility study, which will be used to guide the framing and design of the final telemedicine supported vHaH model for hospitalized patients.

Conditions

Telemedicine; Epidemic Disease

Outcome Measures

Primary Outcomes (9)

• Percentage of all planned daily video supported ward rounds provided

  successful protocol adherence is defined by 80%

  through study completion, approximately 18 months

• Percentage of all planned self-measurements transmitted by patient

  successful protocol adherence is defined by 80%

  through study completion, approximately 18 months

• Percentage of all acute contact requests from patients handled within pre-defined time

  successful protocol adherence is defined by 80%

  through study completion, approximately 18 months

• Percentage of all non-acute contact requests from patients handled within pre-defined time

  successful protocol adherence is defined by 80%

  through study completion, approximately 18 months

• Percentage of all red alarms triggered by EWS-change handled within pre-defined time

  successful protocol adherence is defined by 80%

  through study completion, approximately 18 months

• Percentage of all yellow alarms triggered by EWS-change handled within pre-defined time

  successful protocol adherence is defined by 80%

  through study completion, approximately 18 months

• Number of recruited participants

  recruitment success is defined as 80%

  through study completion, approximately 18 months

• Number of drop-out participants

  success is defined by brop out less than 10%

  through study completion, approximately 18 months

• Number and type of outcome assessment completed by participants.

  through study completion, approximately 18 months

Secondary Outcomes (18)

• Patient related endpoints: Compound of clinical events

  30 days efter the discharge.

• Patient related endpoints: Loss of function

  Three months after discharge

• Patient related endpoints: Productivity losses

  Three months after discharge of patient

• Patient related endpoints: Self-perceived quality of care

  Three months after discharge of patient

• Next of kin related endpoints: Quality of Life

  Three months after discharge of patient

Study Arms (1)

App and Case Management system with algorithms

OTHER

Feasibility study of hospital at home model including telemedicine and specifically developed app and case management system

Other: Virtual Hospital at Home - Home admission of epidemic patients

Interventions

Virtual Hospital at Home - Home admission of epidemic patients OTHER

Admitting COVID-19 patients at home

App and Case Management system with algorithms

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years of age
• Signed informed written and oral consent
• Lower tract respiratory infections, including contagious infection (e.g. SARS CoV 2 and Influenza).
• Considered not ready for discharge for at least 24 hours, assessed by attending MD in the COVID-19 ward.
• Patients are self-reliant or receives sufficient formal care to be care-independent of primary informal caregiver
• \- Medically eligible for vHaH, including but not solely dependent of following conditions, assessed by the attending VEC MD:
• Actual condition assessed to be clinically stable.
• Green or yellow-tag triage based on vital parameters, including total adjusted EWS-score ≤6 and no adjusted single parameter score of 3 or above (See appendix 1)
• Requires less than 5L/min of oxygen supplement
• Stable or decreasing need for oxygen supplement
• Stable or decreasing paraclinical infection parameters such as C-reactive protein (CRP) etc.
• Home-based admission will be located within catchment area of the hospital (according to the official address of the individual).

You may not qualify if:

• Patients who cannot participate in interaction via App
• Lack of sufficient Danish language skills to understand and interact with requirements and staff at a patient safe level
• Patient residency cannot offer isolated room (COVID-19 patients only)
• Pregnancy
• Signed informed written and oral consent
• Study patient is included in the study
• Age ≥ 18 years

Sponsors & Collaborators

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

Study Sites (1)

Nordsjaellands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (1)

• Sandreva T, Larsen MN, Rasmussen MK, Nielsen TL, von Sydow C, Schmidt TA, Fischer TK. Transforming health care: Investigating Influenzer, a novel telemedicine-supported early discharge program for patients with lower respiratory tract infection: A non-randomized feasibility study. J Telemed Telecare. 2025 Sep;31(8):1138-1151. doi: 10.1177/1357633X241254572. Epub 2024 May 23.

  PMID: 38780386 DERIVED

Study Officials

• Thea K Fischer, MD

  Nordsjaellands Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The study is a clinical feasibility study. We anticipate to enroll 20 participants. Participants are admitted patients with a lower respiratory infection are 18 years of age or older and have been admitted at the hospital for at least 24 hour. additionally they must be and are considered suitable for home admission according o the inclusion- and exclusion criteria. The participants will be a part of the study until discharge or withdrawal of consent. If a next-of-kin is identified as primary informal caregiver this person is offered to take participate in the study as well. Follow-up questionnaires will be sent to all participants, and follow-up interviews will be performed after discharge.

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: October 21, 2021
• Study Start: April 20, 2022
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)