Heart FailureNWECHANCENCT04084964
Feasibility Study of a Home Hospitalisation Strategy for Patients With Heart Failure
A study testing Home-hospitalisation platform for heart failure in people with Heart Failure, run by Hasselt University at 1 site in Belgium.
Trial summary
This feasibility study is part of a larger interregional European project (NWE-Chance) financially supported by the 'Interreg North West Europe' program to develop and validate promising integrated eHealth applications combined with nanotechnology for hospitalisation of heart failure patients at home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Home-hospitalisation platform for heart failure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2020to 1 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known and well assessed chronic heart failure.
- Age>18 years
- (Indication for) hospital admission for acute decompensated heart failure
- Living within a wide proximity of the hospital (differs per centre)
- Living independently and/or sufficiently supported at home and/or living in nursing homes (or other supported living modalities).
Who cannot join
- Indication for IC/CCU admission;
- Contraindication to Chance@Home;
- Mental impairment leading to inability to cooperate;
- Severe comorbidity requiring simultaneous hospital care;
- History of severe liver / kidney disease;
- Unstable blood pressure (systolic blood pressure <90mmHg);
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- Unstable heart rhythm (in case of sinus rhythm, heart rate >110/min, in case of atrial fibrillation >150/min);
- Need for intravenous inotropic medication;
- Unstable respiratory condition (sO2 <90% without additional O2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NWE CHANCE Feasibility Study of a Home Hospitalisation Strategy for Patients With an Acute Episode of Heart Failure Using Integrated eHealth Applications.
This feasibility study is part of a larger interregional European project (NWE-Chance) financially supported by the 'Interreg North West Europe' program to develop and validate promising integrated eHealth applications combined with nanotechnology for hospitalisation of heart failure patients at home. For more information on this research project and the partners see http://www.nweurope.eu/nwe-chance
Read the detailed description
Patients participating in the NWE-Chance study will be transferred to their home supported by the integrated home hospitalisation platform and a daily visit by a specialised nurse. The home hospitalisation platform allows monitoring vital signs of patients by using the Sensium patch and a connected weighing scale and blood pressure meter of HC@home. Blood parameters like creatinine and potassium will be measured (daily) by using the Medimate lab-on-chip technology (more information below). Patients will get a smartphone to receive reminders for measurements of blood pressure and weight and will be able to see the evolution of their blood pressure and weight values. The patient application also contains educational information for the patient on home hospitalisation and on how to take the measurements correctly.
Patients are treated by a team of specialised nurses under supervision of a cardiologist. The nurses visit patients at least once a day and are equipped with laboratory equipment and IV medication administering equipment. These devices and equipment are currently used in standard HF care and are not part of the newly developed home hospitalisation platform. Patients receive treatment similar to in-hospital treatment, according to the cardiologist's best knowledge and insight.
In the case of Jessa Hospital, if there would be a need for IV medication during the home-hospitalisation period, this will lead to rehospitalisation of the patient and the ending of the intervention. In Isala, the nurses have a 24/7 duty service and can be called by patients or their relatives on their own initiative. In Jessa hospital and MUMC+, the nursing team can be contacted between 9 AM and 17 PM. During other hours, the patients can contact the cardiologist on call.
In case of treatment failure or severe deterioration, patients will be transported to the hospital. In case of emergency, ambulances will transport patients to the hospital (conversion to regular hospitalisation). If in follow-up, condition worsens, the patient can be readmitted at home again. In theory, patients may undergo repeated hospitalisations at home.
The home-hospitalisation period will last at least 5 days and can be extended, till a maximum of 13 days, after consultation of a cardiologist. Patient will be asked to fill in questionnaires to assess feasibility at the end of the home-hospitalisation period (last visit of nurse). At the last visit of the nurse, she will take all the devices with her.
- Conditions
- Heart Failure
- Being tested
- Home-hospitalisation platform for heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-hospitalisation platform for heart failureOther
The primary objective of the INTERREG NWE-Chance project is the development of an integrated home-hospitalisation platform and the assessment of the feasibility of a home hospitalisation strategy for heart failure patients.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | These patients receive the home-hospitalisation platform Receives: Other: Home-hospitalisation platform for heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability will be assessed with the SUTAQ questionnaire adapted for home-hospitalisation
The SUTAQ or the Service User Technology Acceptability Questionnaire is to measure acceptability and identify the characteristics of persons who were likely to reject technological health services Will be assessed after the home-hospitalisation in patients and staff. There are 20 questions that can be answered with 6 answer possibilities ranging from fully disagree to fully agree. These answered will be coded to numbers ranging from 1-6 (6 is fully agree, 1 fully disagree). The total score is 120 and the range for the score can be 20-120
Measured: 5-14 days
Usability will be assessed with the SUS questionnaire adapted for home-hospitalisation
SUS or the System Usability Scale will be used after the home-hospitalisation to assess the usability of the platform for the patients and staff. There are 10 questions in total with 5 answer possibilities ranging from totally agree to fully disagree. The answers will be coded to numbers (1-5) and 5 means totally agree and 1 is fully disagree. The total score is 50 and the range for the score can be 10-50
Measured: 5-14 days
Satisfaction will be assessed with the Satisfaction Home-hospitalisation program questionnaire
The satisfaction of the home-hospitalisation program questionnaire consist of 19 questions and will be used to assess the satisfaction of patients. There are 5 answer possibilities ranging from completely satisfied to very dissatisfied. The answers will be coded to numbers (1-5) and 5 means completely satisfied and 1 is very dissatisfied. The total score is 95 and the range for the score can be 19-95
Measured: 5-14 days
Platform use will be assessed with the amount of logs in the patient application
Measured: 5-14 days
Number of adverse events will be mapped by the study team
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Oct 2020
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The NWE-Chance feasibility study is an international, multicenter, single-arm prospective and interventional study.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital, Isala, Maastricht University Medical Center
- Responsible party
- Principal investigator, prof. dr. Paul Dendale, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084964
- Sponsor's protocol ID
- NWE 661
- Acronym
- NWECHANCE
- Status last verified
- Mar 2022
- First submitted
- 5 Sep 2019
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leenen JPL, Scherrenberg M, Bruins W, Boyne J, Vranken J, Brunner la Rocca HP, Dendale P, van der Velde AE. Usability of a digital health platform to support home hospitalization in heart failure patients: a multicentre feasibility study among healthcare professionals. Eur J Cardiovasc Nurs. 2024 Mar 12;23(2):188-196. doi: 10.1093/eurjcn/zvad059.
PubMed 37294588
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NWE CHANCE Feasibility Study of a Home Hospitalisation Strategy for Patients With an Acute Episode of Heart Failure Using Integrated eHealth Applications.
- ClinicalTrials.gov ID
- NCT04084964
- Acronym / sponsor ID
- NWECHANCE / NWE 661
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital, Isala, Maastricht University Medical Center
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 10 Sep 2019 (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 feasibility study is part of a larger interregional European project (NWE-Chance) financially supported by the 'Interreg North West Europe' program to develop and validate promising integrated eHealth applications combined with nanotechnology for hospitalisation of heart failure patients at home. For more information on this research project and the partners see http://www.nweurope.eu/nwe-chance
Detailed description
Patients participating in the NWE-Chance study will be transferred to their home supported by the integrated home hospitalisation platform and a daily visit by a specialised nurse. The home hospitalisation platform allows monitoring vital signs of patients by using the Sensium patch and a connected weighing scale and blood pressure meter of HC@home. Blood parameters like creatinine and potassium will be measured (daily) by using the Medimate lab-on-chip technology (more information below). Patients will get a smartphone to receive reminders for measurements of blood pressure and weight and will be able to see the evolution of their blood pressure and weight values. The patient application also contains educational information for the patient on home hospitalisation and on how to take the measurements correctly.
Patients are treated by a team of specialised nurses under supervision of a cardiologist. The nurses visit patients at least once a day and are equipped with laboratory equipment and IV medication administering equipment. These devices and equipment are currently used in standard HF care and are not part of the newly developed home hospitalisation platform. Patients receive treatment similar to in-hospital treatment, according to the cardiologist's best knowledge and insight.
In the case of Jessa Hospital, if there would be a need for IV medication during the home-hospitalisation period, this will lead to rehospitalisation of the patient and the ending of the intervention. In Isala, the nurses have a 24/7 duty service and can be called by patients or their relatives on their own initiative. In Jessa hospital and MUMC+, the nursing team can be contacted between 9 AM and 17 PM. During other hours, the patients can contact the cardiologist on call.
In case of treatment failure or severe deterioration, patients will be transported to the hospital. In case of emergency, ambulances will transport patients to the hospital (conversion to regular hospitalisation). If in follow-up, condition worsens, the patient can be readmitted at home again. In theory, patients may undergo repeated hospitalisations at home.
The home-hospitalisation period will last at least 5 days and can be extended, till a maximum of 13 days, after consultation of a cardiologist. Patient will be asked to fill in questionnaires to assess feasibility at the end of the home-hospitalisation period (last visit of nurse). At the last visit of the nurse, she will take all the devices with her.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The NWE-Chance feasibility study is an international, multicenter, single-arm prospective and interventional study.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Home-hospitalisation platform for heart failureThese patients receive the home-hospitalisation platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with known and well assessed chronic heart failure.
- Age>18 years
- (Indication for) hospital admission for acute decompensated heart failure
- Living within a wide proximity of the hospital (differs per centre)
- Living independently and/or sufficiently supported at home and/or living in nursing homes (or other supported living modalities).
Key exclusion criteria (9 listed)
- Indication for IC/CCU admission;
- Contraindication to Chance@Home;
- Mental impairment leading to inability to cooperate;
- Severe comorbidity requiring simultaneous hospital care;
- History of severe liver / kidney disease;
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 |
|---|---|---|
| Home-hospitalisation platform for heart failureThe primary objective of the INTERREG NWE-Chance project is the development of an integrated home-hospitalisation platform and the assessment of the feasibility of a home hospitalisation strategy for heart failure patients. | Other | Study group |
Primary outcome
Acceptability will be assessed with the SUTAQ questionnaire adapted for home-hospitalisation
Time frame: 5-14 days
The SUTAQ or the Service User Technology Acceptability Questionnaire is to measure acceptability and identify the characteristics of persons who were likely to reject technological health services Will be assessed after the home-hospitalisation in patients and staff. There are 20 questions that can be answered with 6 answer possibilities ranging from fully disagree to fully agree. These answered will be coded to numbers ranging from 1-6 (6 is fully agree, 1 fully disagree). The total score is 120 and the range for the score can be 20-120
Usability will be assessed with the SUS questionnaire adapted for home-hospitalisation
Time frame: 5-14 days
SUS or the System Usability Scale will be used after the home-hospitalisation to assess the usability of the platform for the patients and staff. There are 10 questions in total with 5 answer possibilities ranging from totally agree to fully disagree. The answers will be coded to numbers (1-5) and 5 means totally agree and 1 is fully disagree. The total score is 50 and the range for the score can be 10-50
Satisfaction will be assessed with the Satisfaction Home-hospitalisation program questionnaire
Time frame: 5-14 days
The satisfaction of the home-hospitalisation program questionnaire consist of 19 questions and will be used to assess the satisfaction of patients. There are 5 answer possibilities ranging from completely satisfied to very dissatisfied. The answers will be coded to numbers (1-5) and 5 means completely satisfied and 1 is very dissatisfied. The total score is 95 and the range for the score can be 19-95
Platform use will be assessed with the amount of logs in the patient application
Time frame: 5-14 days
Number of adverse events will be mapped by the study team
Time frame: 30 days
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 15 Mar 2022.
- Derived from this study: PubMed 37294588Leenen JPL, Scherrenberg M, Bruins W, Boyne J, Vranken J, Brunner la Rocca HP, Dendale P, van der Velde AE. Usability of a digital health platform to support home hospitalization in heart failure patients: a multicentre feasibility study among healthcare professionals. Eur J Cardiovasc Nurs. 2024 Mar 12;23(2):188-196. doi: 10.1093/eurjcn/zvad059.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-hospitalisation platform for heart failure in people with Heart Failure, run by Hasselt University at 1 site in Belgium.
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 5 inclusion and 9 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 15 Mar 2022. 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 Belgium. 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?
Acceptability will be assessed with the SUTAQ questionnaire adapted for home-hospitalisation (time frame: 5-14 days). The study lists 5 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 NCT04084964, which also lists 1 linked publication.
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 15 Mar 2022.