Clinical trial NCT04084964: Feasibility Study of a Home Hospitalisation Strategy for Patients With Heart Failure
Official title: NWE CHANCE Feasibility Study of a Home Hospitalisation Strategy for Patients With an Acute Episode of Heart Failure Using Integrated eHealth Applications.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
name: Isala
name: Maastricht University Medical Center
First posted: 2019-09-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The NWE-Chance feasibility study is an international, multicenter, single-arm prospective and interventional study.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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);
* 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)

Primary outcomes:
measure: Acceptability will be assessed with the SUTAQ questionnaire adapted for home-hospitalisation
timeFrame: 5-14 days
measure: Usability will be assessed with the SUS questionnaire adapted for home-hospitalisation
timeFrame: 5-14 days
measure: Satisfaction will be assessed with the Satisfaction Home-hospitalisation program questionnaire
timeFrame: 5-14 days
measure: Platform use will be assessed with the amount of logs in the patient application
timeFrame: 5-14 days
measure: Number of adverse events will be mapped by the study team
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
Study officials:
References: