The SmartBEAT project aims to address the needs of senior Chronic Heart Failure (CHF) patients and their formal and informal caregivers, by offering an integrated solution to leverage patient self-care through autonomous condition monitoring and…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study:
1. Test of accuracy, reproducibility and user interface of the SmartBEAT system
(method Jakob Nielsen heuristics):
Outcome: accuracy, reproducibility and user-friendliness
2. Pilot test:
Outcome measure: usability
Reporting usability issues, and where necessary, changes to the
SmartBEAT solution.
3. Field test:
Outcome measure: perceptions
Factors: user experiences user-friendliness, acceptance, usability,
design and comfort, and the influence of the human factor
On the reliability of the system
No part of this study:
- Medium-sized RCT
Outcome measure: congestion
- Large scale RCT
Outcome measure: hospitalizations
Secondary outcome
not applicable
Background summary
More and more older people are in bad health for 20-25% of their lives,
suffering from one or more chronic conditions such as chronic heart failure
(CHF). In this light, the SMARTBEAT project (ie the development of an
intelligent heart failure management system) is funded by the AAL program (EU)
(see also http://www.aal-europe.eu/smartbeat/).
In SMARTBEAT, a care system is established to measure physiological parameters
via telemonitoring devices. On an online platform, the data is safely stored
and processed with intelligent algorithms, in order to make the comparison with
baseline values **to detect deviations in the patient's health pattern. Then
feedback and coaching are provided for the patient using a smartphone
application. Formal as informal caregivers have secure access to a 'Caregivers
portal' (a web application). Depending on the type of healthcare provider (ie
formal or informal), the details of the medical data can be filtered.
The care system uses devices that measure the following parameters:
- Continuous monitoring: heart rate, physical activity
- Daily determination: blood pressure, heart rate at rest, weight, impedance,
oxygen saturation, heart rhythm.
Study objective
The SmartBEAT project aims to address the needs of senior Chronic Heart Failure
(CHF) patients and their formal and informal caregivers, by offering an
integrated solution to leverage patient self-care through autonomous condition
monitoring and real-time feedback to their caregivers. This objective will be
achieved through remote measurement of patients* physiological data and a smart
phone application integrated with a monitoring engine and a caregivers gateway
for data analysis, management and reporting.
Goal of the study is to evaluate the SmartBEAT alpha prototype from a user
perspective.
Study design
Research Protocol:
In order to achieve a high level of acceptance - for both CHF patients and
caregivers - the system must be attractive in terms of functionality, design
and interaction.
Before the care system is tested with CHF patients and caregivers, all
SmartBEAT modules and interfaces are tested at the technical level and
evaluated by multiple gerontologists and interface designers. This way,
technical errors and malfunctions, important user issues and design errors can
be solved before using the technology in the study with patients.
Then patients and caregivers are asked to use the care system.
The SMARTBEAT study consists of two phases:
- Pilot study (Sept / Oct 2017): Evaluation of functionality, design and level
of interaction (3 patients)
- Fieldtrail (Jan - June 2018): Daily use of care system (10 patients)
The selection of the patients for the study is performed by the nurse in
consultation with the GP. Patients who meet the inclusion criteria are
approached for participation. In a conversation, the patient receives the
necessary information about the study (including patient information letter,
informed consent) and the request for participation.
Care protocol:
Patients participating in SMARTBEAT get the required telemonitoring devices
installed at their home. After that, they get education about the use of the
devices, the app and the time when the measurements should take place. Each
patient should measure the following parameters after his / her morning ritual:
- blood pressure
- Weight
- Heartbeat at rest
- Oxygen saturation
- Impedance
- heart rhythm
Active heart rate and physical activity are recorded continuously.
If the patient measures deviant values **for 2 consecutive days, he will be
prompted to fill in a digital questionnaire via the app that checks possible
symptoms of CHF. In addition, the app will also monitor patient's medication in
the context of his / her heart failure, and indicate the doses for daily
intake. The patient must indicate via the app whether he has taken the
medication. Non-heart failure-related medication is not followed by the app.
Study burden and risks
The study concerns a research into the functionality, design and the embedding
of telemonitoring in daily patterns of both patients and healthcare providers.
The SmartBEAT care system is applied in this study in addition to regular care
(i.e. not replacing regular care, this will be investigated later in a RCT in
Portugal)
Tilburgseweg-West 100
Eindhoven 5652 NP
NL
Tilburgseweg-West 100
Eindhoven 5652 NP
NL
Listed location countries
Age
Inclusion criteria
- patient should be 65 years of age or older;
- patient has chronic heart failure with NYHA Classification II or III;
- patient has an ejection fraction (EF) < 40%;
- patient has been clinically stable and has not been hospitalized for CHF in the past 2 months.
Exclusion criteria
- Patient is not yet 65 years of age;
- Condition of the patient is not suitable;
- Patient had been hospitalized in the past 2 months.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61587.100.17 |