The primary objective of this project is to assess the adherence to a patient-centred integrated lifestyle monitoring system that tracks daily physical activity levels, dietary habits, mental stress and sleep quality.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the adherence (i.e., the % of participants still using
a patient-centred lifestyle monitoring system at 1-year follow-up).
Secondary outcome
The secondary endpoints are:
- Usability will be measured using the System Usability Scale (SUS) score and
success rate.
- To measure the correlation of demographic and disease characteristics,
quality of life, self-efficacy, depressive symptoms, anxiety, motivation, stage
of change, fatigue, physical fitness, levels of metal stress, use of a goal
tracking functionality, use of the sharing functionality with external
contacts, perception of system usability and prior experience with technology
with adherence. Standardized questionnaires will be used for self-report
measures and objective ambulatory measures from the lifestyle monitoring system
for objective lifestyle measures.
- The association between adherence with clinical outcomes will be examined by
evaluation patient clinical records (clinical events) and standardized
self-report data (quality of life).
Background summary
In cardiac rehabilitation (CR), technological innovations can help to improve
patient relevant outcomes and reduce health care costs. Lifestyle and
psychological wellbeing are considered pivotal in this field as physical
fitness, daily physical activity levels, dietary habits, mental stress, sleep
quality and smoking habit, are strongly related to the occurrence, clinical
course and overall treatment outcomes of common cardiovascular diseases (CVD*s)
such as coronary artery disease (CAD) and atrial fibrillation (AF). In fact,
quality of life is often not improved after major cardiac interventions and
persistent unhealthy lifestyle factors have adverse effects on the clinical
course of patients with coronary artery disease and atrial fibrillation.
However, despite their undisputed relevance, these lifestyle factors are
currently not objectively and subjectively monitored and therefore not
optimally used to the advantage of patients in daily clinical practice. We
postulate that more insight in the patients* daily lifestyle behaviour provides
crucial information that can be used to improve patient selection for cardiac
interventions. In addition, objective and subjective monitoring can be used to
personalize lifestyle interventions, leading to improvements of in-hospital and
long-term outpatient clinical care, as well as better self-motivation, quality
of life and health status.
Adherence to continuously providing self-tracking data via automatically
monitoring technologies is key. Without data provided by the patients,
personalized and improved treatment decisions cannot be made. However, there is
a gap in literature regarding the adherence to continuous lifestyle monitoring
technologies for a longer period of time. Whereas previous research showed high
levels of adherence associated with monitoring technology, these studies
focused on relatively short programs. Secondly, studies typically focus on
monitoring only one lifestyle domain rather than a combination. Yet, the use of
monitoring technology to improve fitness and wellbeing is a clear trend and may
potentially be particularly useful as assistive tool to stimulate healthy
lifestyle in special population. Therefore, there is a clear need for further
research in evaluation of the adherence and usability of this kind of digital
health technology in CVD care and management.
This project aims to develop and evaluate the adherence and usability of a
system that integrates innovative methods for continuous unobtrusive and
patient-friendly monitoring of lifestyle factors (i.e. daily physical activity
levels, dietary habits, mental stress and sleep quality) in patients with
coronary artery disease (i.e. patients selected for coronary artery bypass
surgery (CABG), radiofrequency catheter ablation (RFCA), a transcathethr aortic
valve implantation (TAVI), or valve surgery). These patient groups are selected
because the diseases are common, treatment decisions are often complex, and
technically and medically successful treatments are often not accompanied by
optimal changes in lifestyle factors. A system that aids patients in monitoring
their lifestyle factors will enable better self-management and improve
self-motivation, with subsequent positive effects on the lifestyle factors
themselves. Therefore, this study will investigate adherence to self-monitoring
lifestyle with a novel integrated lifestyle monitoring system.
Study objective
The primary objective of this project is to assess the adherence to a
patient-centred integrated lifestyle monitoring system that tracks daily
physical activity levels, dietary habits, mental stress and sleep quality.
Study design
This is a prospective observational trial.
Study burden and risks
No risks are associated with participation in the present study. An activity
tracker will be worn 2 weeks per month for a one-year period to collect data on
activity behaviour (step count, accelerometer counts and heart rate) and sleep
duration. Subjective data will on nutritional intake, mental stress and sleep
quality will be acquired via questionnaires and a chatbot connected to a
patient monitoring system accessible via mobile phone, tablet and desktop.
Patient-reported outcomes will be obtained using standard questionnaires at
three-months intervals. Patients will have insight in their lifestyle data but
will not receive treatment or coaching based upon these parameters (caretakers
do not have access to the platform) as this project is focused on a
patient-centred monitoring approach.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
- Patients selected for or that underwent coronary artery bypass surgery
(CABG), an electrophysiological test (EFO) and/orradiofrequency catheter
ablation (RFCA), a transcatheter aortic valve implantation (TAVI), a fractional
flow reservetest (FFR) and/or a percutaneous coronary intervention (PCI),
and/or valve surgery.
- Age >= 18 years.
- Able to speak and read the Dutch language.
- Willing and able to provide informed consent.
Exclusion criteria
- No internet connection at home.
- Not in possession of a computer or tablet, and mobile phone.
- Not able or willing to wear activity tracker on a daily basis (for example
due to work related obligations).
- Major planned (cardiac) surgery in the upcoming 3 months.
- Life expectancy < 1 year (e.g., severe renal disease, metastatic cancer).
- Physical impairments interfering with the lifestyle monitoring system,
including not able to perform daily physical activities due to orthopaedic or
neurological disease, bed/chair ridden patients, visual impairments/blindness,
sever cognitive disability.
- Presence of wounds, injuries or infectious diseases on the skin where the
wrist-wearable device(s) will be placed.
- Refusal to informed consent.
- Mentally incompetent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL78062.015.21 |
| OMON | NL-OMON20607 |