InfectionHosp@HomeNCT04898452
Intravenous Antibiotic Treatment at Home
An observational study of Infection, run by Helse Møre og Romsdal HF at 1 site in Norway.
Trial summary
The purpose of the study is to develop and evaluate a new model for across services interaction with the use of welfare technology and telemedicine. The model includes innovative and new routines for the exchange of patient information, quality systems and procedures between the municipality and the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- A new model of interaction across health services with use of welfare technology and telemedicine
- Type of treatment
- Injection or infusion
- How many people
- 19 participants
- Where
- 1 siteNorway
- Study dates
- 2 Jul 2020to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients participate in both study part 1 (qualitative) and study part 2 (quantitative). Health professionals and next to kins participate in study part 1 (qualitative).
Who may be able to join
- Main or bi-diagnosis during stay:
- A692 Borreliosis G00 - G009 Central nervous system inflammatory disorders I33 Endocarditis J86 Empyema D46.3 Spondylodiscitis M86 Osteomyelitis T84 Prosthesis / osteosynthesis infections M00.0-M00.9 Pyogen / septic arthritis J40-J47 Chronic diseases of the lower respiratory tract
- Competent to give consent
- The infection can not be treated with oral antibiotics in monotherapy
- Selected IV antibiotics must be suitable for administration via selected pumps
- The patient's condition is stable and does not require frequent observation by health care professionals
Show all 10Show fewer
- The patient is motivated and willing to participate in intravenous treatment in home hospitals
- Must, after training, demonstrate mastery of practical procedures related to pump handling and any other procedures described in the patient's treatment plan
- The home must be suitable for intravenous antibiotic treatment; access to refrigerators, hygienic conditions, social conditions
- The patient must have a mobile phone and be able to handle the system for fast and secure communication with the Regional Response Center (RRO)
Who cannot join
- consent not given
Trial locations and contacts
1 site in 1 country.
Norway1 site
Helse Møre og Romsdal HF, Kristiansund sjukehus, Medisinsk Avdeling
Kristiansund
About this study
Official title: Intravenous Antibiotic Treatment at Home: A New Model for Across Services Interaction With the Use of Welfare Technology and Telemedicine.
The purpose of the study is to develop and evaluate a new model for across services interaction with the use of welfare technology and telemedicine. The model includes innovative and new routines for the exchange of patient information, quality systems and procedures between the municipality and the hospital. This model will first be tested for use in intravenous antibiotic therapy. The results of the study will be used to further develop the service. In the larger context, it is desirable to provide knowledge that is transferable to other diagnostic groups, treatment methods and geographical areas.
Read the detailed description
This research-based innovation study has an evaluation approach with follow-up evaluation as the overall approach.
The pre-project was carried out with a qualitative approach under the auspices of SINTEF 2018/2019.
The main project consists of sub-study 1 and sub-study 2 (2020/2022).
Sub-study 1: The project use an iterative, user-centered service methodology with a qualitative approach. Here, SINTEF has the main responsibility for a qualitative summary after conducting interviews, observations and group discussions with patients, next of kins and health professionals regarding the development and testing / quality assurance of the new concept / service course for home treatment.
Sub-study 2: The approach here is quantitative. Descriptive data must be obtained from the hospital and municipal patient records, patient administration system (PAS) at Kristiansund hospital, alarm data from the Regional Response Center and pump log from the individual patient's infusion pump after home treatment.
- Conditions
- Infection
- Being tested
- A new model of interaction across health services with use of welfare technology and telemedicine
- Keywords
- Home Care Services, Hospital-Based, Telemedicine, Home Infusion Therapy, Hospital at home, Antibiotics
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A new model of interaction across health services with use of welfare technology and telemedicineOther
Instead of admitted to the hospital, patients are followed up at home by the municipal regional response center and nurses in the response team according to the individual treatment plan. Hospital physicians are medically responsible throughout the course.
| Study group | Role | What they receive |
|---|---|---|
| Patients needing antibiotics infusion | Patients needing antibiotics infusion A new model of interaction across health services with use of welfare technology and telemedicine Instead of admitted to the hospital, patients are followed up at home by the municipal regional response center and nurses in the response team according to the individual treatment plan. Hospital physicians are medically responsible throughout the course. Receives: Other: A new model of interaction across health services with use of welfare technology and telemedicine | |
| Next of kin | Next of kin A new model of interaction across health services with use of welfare technology and telemedicine Instead of admitted to the hospital, patients are followed up at home by the municipal regional response center and nurses in the response team according to the individual treatment plan. Hospital physicians are medically responsible throughout the course. Receives: Other: A new model of interaction across health services with use of welfare technology and telemedicine | |
| Health professionals | A new model of interaction across health services with use of welfare technology and telemedicine Instead of admitted to the hospital, patients are followed up at home by the municipal regional response center and nurses in the response team according to the individual treatment plan. Hospital physicians are medically responsible throughout the course. Receives: Other: A new model of interaction across health services with use of welfare technology and telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of rehospitalisations
Measured: 45 months
patient satisfaction
assessed with semi-structured interview
Measured: 45 months
health personnel's opinion on patient safety
based on answers in web-case-registration-form (CRF)
Measured: 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start2 Jul 2020
- Primary completion22 Jul 2025
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Collaborators
- SINTEF Health Research, Kristiansund municipality, Centre for Health Innovation, Hospital Pharmacy of Central Norway Trust
- Responsible party
- Sponsor
- Investigators
- Torstein Hole, md phd, Study director, Møre og Romsdal Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898452
- Sponsor's protocol ID
- 2019/60
- Acronym
- Hosp@Home
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2020
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Antibiotic Treatment at Home: A New Model for Across Services Interaction With the Use of Welfare Technology and Telemedicine.
- ClinicalTrials.gov ID
- NCT04898452
- Acronym / sponsor ID
- Hosp@Home / 2019/60
- Conditions
- Infection
- Keywords
- Home Care Services, Hospital-Based, Telemedicine, Home Infusion Therapy, Hospital at home, Antibiotics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Collaborators
- SINTEF Health Research, Kristiansund municipality, Centre for Health Innovation, Hospital Pharmacy of Central Norway Trust
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 24 May 2021 (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.
The purpose of the study is to develop and evaluate a new model for across services interaction with the use of welfare technology and telemedicine. The model includes innovative and new routines for the exchange of patient information, quality systems and procedures between the municipality and the hospital. This model will first be tested for use in intravenous antibiotic therapy. The results of the study will be used to further develop the service. In the larger context, it is desirable to provide knowledge that is transferable to other diagnostic groups, treatment methods and geographical areas.
Detailed description
This research-based innovation study has an evaluation approach with follow-up evaluation as the overall approach.
The pre-project was carried out with a qualitative approach under the auspices of SINTEF 2018/2019.
The main project consists of sub-study 1 and sub-study 2 (2020/2022).
Sub-study 1: The project use an iterative, user-centered service methodology with a qualitative approach. Here, SINTEF has the main responsibility for a qualitative summary after conducting interviews, observations and group discussions with patients, next of kins and health professionals regarding the development and testing / quality assurance of the new concept / service course for home treatment.
Sub-study 2: The approach here is quantitative. Descriptive data must be obtained from the hospital and municipal patient records, patient administration system (PAS) at Kristiansund hospital, alarm data from the Regional Response Center and pump log from the individual patient's infusion pump after home treatment.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients needing antibiotics infusion | – | Other: A new model of interaction across health services with use of welfare technology and telemedicinePatients needing antibiotics infusion A new model of interaction across health services with use of welfare technology and telemedicine Instead of admitted to the hospital, patients are followed up at home by the municipal regional response center and nurses in the response team according to the individual treatment plan. Hospital physicians are medically responsible throughout the course. |
| Next of kin | – | Other: A new model of interaction across health services with use of welfare technology and telemedicineNext of kin A new model of interaction across health services with use of welfare technology and telemedicine Instead of admitted to the hospital, patients are followed up at home by the municipal regional response center and nurses in the response team according to the individual treatment plan. Hospital physicians are medically responsible throughout the course. |
| Health professionals | – | Other: A new model of interaction across health services with use of welfare technology and telemedicineA new model of interaction across health services with use of welfare technology and telemedicine Instead of admitted to the hospital, patients are followed up at home by the municipal regional response center and nurses in the response team according to the individual treatment plan. Hospital physicians are medically responsible throughout the course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients participate in both study part 1 (qualitative) and study part 2 (quantitative). Health professionals and next to kins participate in study part 1 (qualitative).
Key inclusion criteria (10 listed)
- Main or bi-diagnosis during stay:
- A692 Borreliosis G00 - G009 Central nervous system inflammatory disorders I33 Endocarditis J86 Empyema D46.3 Spondylodiscitis M86 Osteomyelitis T84 Prosthesis / osteosynthesis infections M00.0-M00.9 Pyogen / septic arthritis J40-J47 Chronic diseases of the lower respiratory tract
- Competent to give consent
- The infection can not be treated with oral antibiotics in monotherapy
- Selected IV antibiotics must be suitable for administration via selected pumps
Key exclusion criteria (1 listed)
- consent not given
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 |
|---|---|---|
| A new model of interaction across health services with use of welfare technology and telemedicineInstead of admitted to the hospital, patients are followed up at home by the municipal regional response center and nurses in the response team according to the individual treatment plan. Hospital physicians are medically responsible throughout the course. | Other | Health professionals, Next of kin, Patients needing antibiotics infusion |
Primary outcome
number of rehospitalisations
Time frame: 45 months
patient satisfaction
Time frame: 45 months
assessed with semi-structured interview
health personnel's opinion on patient safety
Time frame: 45 months
based on answers in web-case-registration-form (CRF)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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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.
Torstein Hole, md phd study director
Møre og Romsdal Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Helse Møre og Romsdal HF at 1 site in Norway.
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 10 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
number of rehospitalisations (time frame: 45 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2026.