1. To investigate whether the TIMELY intervention is superior to usual care in terms of A) reducing the CoroPredict risk score (indicating risk of 10-year mortality: primary biomedical outcome) from baseline to six months; andB) increasing…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To investigate whether the TIMELY intervention is superior to usual care in
terms of
A) reducing the CoroPredict risk score (indicating risk of 10-year mortality:
primary biomedical outcome) from baseline to six months; and
B) increasing functional fitness levels (6-minute walk test) primary
behavioural outcome) from baseline to 6 months
Secondary outcome
The improvements under primary objectives are expected to be associated with
improvements in the secondary outcomes:
a. Physical activity levels and cardiovascular responses to exercise
b. Healthy dietary habits
c. Smoking cessation
d. Medication adherence
e. Reducing psychological stress levels
1. To investigate whether the TIMELY intervention is superior to care as usual
in terms of improvement in physical and mental well-being and quality of life
2. To investigate the feasibility and usability of the TIMELY intervention.
3. To investigate whether the TIMELY intervention is superior to care as usual
in terms of cost-effectiveness
Background summary
Cardiovascular diseases (CVD) are the leading cause of death globally according
to the WHO. The highest burden of disease among CVDs is caused by coronary
artery disease (CAD). Ageing predisposes patients to a high incidence and
prevalence of CAD, in both men and women. Older patients have the greatest
mortality and morbidity risk attributable to Chronic Coronary Syndromes (CCS),
partially due to the high prevalence of comorbidities.
Secondary prevention through comprehensive cardiac rehabilitation (CR) has been
recognized as the most cost-effective intervention to limit the physiological
and psychological effects of CVDs and reduce the risk of future cardiovascular
events. Contrary to pharmacological or invasive interventions for CAD, CR is
far from being well implemented in all European countries and participation
rates in available programs range between 30-50% of eligible patients.
The TIMELY platform has been developed to stimulate a healthy lifestyle after
CR. Patient-related barriers for digital health mainly involve the usability of
the CR platform, especially for older patients. Thus, TIMELY includes digital
tools and interfaces that will not hinder senior citizens from using them, as
patient co-design has guided the development.
Since lifestyle changes are key in the prevention and self-management of CAD,
the main component of the TIMELY platform will be an app built on behavioral
change techniques and models to empower and motivate patients to adopt a
healthy lifestyle. Artificial intelligence (AI) will be employed to adapt the
platform to the most current needs of the patient. In addition to prevention
and self-management, the TIMELY platform will constantly monitor and predict
the individual risk for disease progression or serious events and complications
using validated risk scores (CoroPredict®). Next to monitoring physical health,
mental health will be assessed using AI chatbots.
TIMELY will become the first AI-powered, patient-centered eHealth platform that
continuously adapts and customizes CR to meet the needs of patients.
Study objective
1. To investigate whether the TIMELY intervention is superior to usual care in
terms of
A) reducing the CoroPredict risk score (indicating risk of 10-year mortality:
primary biomedical outcome) from baseline to six months; and
B) increasing functional fitness levels (6-minute walk test); primary
behavioural outcome) from baseline to 6 months
Study design
A randomized controlled trial study design will be employed, where patients
will be randomized (1:1) to either the control group receiving usual care or
the intervention group, where patients will receive usual care in combination
with the TIMELY intervention. Assessment will take place at 4 time points:
baseline, 3, 6 and 12 months post inclusion.
Patients will be asked to fill out questionnaires at 4 timepoints: baseline, 3
months, 6 months and 12 months. Through the TIMELY-platform (app) patients in
the intervention group will receive prompts to conduct and ECG and blood
pressure measurement. Patient in the intervention group will be wearing a
Garmin, which collects information about their physical activity patterns.
Lastly, patients will receive physical assessments at three time points
(baseline, 6 months and 12 months), namely an exercise test and bloodwork will
be done.
Intervention
1. Timely app
The TIMELY app will help patients adjust their lifestyle in order for them to
become healthier. The TIMELY app is supported by artificial intelligence and is
based on behavioral change techniques. Through the chatbots the messages aimed
at changing the behavior of patients will be personalized. Specific attention
will be given to promoting physical activity. Because the chatbots can take the
(physical) context of the patient into account, the odds of success are higher.
2. Wrist-worn activity tracker
Patients will receive an activity tracker, which will collect physical
measures, such as level of activity, heart rate and sleep.
3. Tel-O-Graph
Patients will receive a blood pressure monitor, the Tel-O-Graph. The device
additionally measures other hemodynamic parameters through pulse wave analysis
(PWA).
4. Net_ECG
Patients will receive an easy-to-use device capable of registering atrial
fibrillation.
5. eConnect HUB
Patients will receive the eConnect HUB which will transfer all data from the
Tel-O-Graph and the Net_ECG to the researchers.
Study burden and risks
Patients will complete questionnaires at 4 timepoints: baseline, 3 months, 6
months and 12 months. In addition, patients will have conversations with the
chatbots in the app and, based on this, receive encouragement to perform
certain behaviours (e.g. exercise more or eat healthier). Through the TIMELY
platform (app), patients will receive messages to take their ECG and blood
pressure readings. Furthermore, patients will wear a Garmin, which will collect
information about their exercise behaviour. Finally, at the three measurement
moments, patients will receive various physical examinations, namely exercise
tests. Blood will also be drawn at these times.
There are no risks associated with the TIMELY intervention. However, there are
risks associated with the blood test and the exercise test. In rare cases,
cardiac arrhythmias occur during the exercise test. However, this can be dealt
with immediately if necessary. The risks associated with this amount of blood
sampling are small. A patient may experience pain or bruising. The amount of
blood we draw is not enough for patients to feel limp. In very rare cases,
patients may experience a haematoma or damage to a nerve. Because patients have
had blood drawn before without these problems, the chances of this happening
are very low.
The patient is exposed to minimal risks and the time investment is minimal.
Learning how to use the medical devices and then integrating them into regular
use will not take much time. Filling out the questionnaires will also not take
much extra time. The physical examinations will take place three times. This
will still take the most time, but this outweighs the possible benefits
(insight into own functioning, development of better lifestyle, better quality
of life).
Warandelaan 1
Tilburg 5037AB
NL
Warandelaan 1
Tilburg 5037AB
NL
Listed location countries
Age
Inclusion criteria
(1) Age 18 years and over (there is no a priori upper age limit); (2)
Documented stable CAD and referred to cardiac rehabilitation (at > 2 weeks but
< 10 weeks after PCI or > 4 weeks but <12 weeks after CABG or MI: STEMI or
non-STEMI), and/or having documented CAD by coronary angiography (stenosis in a
major coronary artery > 50%); (3) Access and ability to operate a smartphone;
(4) Able to speak the country*s native language.
Exclusion criteria
(1) Unable to fully understand the provided study information and consequences
of participating in the study; (2) presence of a physical impairments
interfering with the use of the app or devices (e.g., blindness, wheelchair
bound); (3) known diagnosis of an active malignant tumors (cancer) or any other
medical condition associated with an expected life expectancy of less than one
year; (4) Unstable cardiovascular, cerebrovascular or other unstable medical
conditions; (5) Refusal to informed consent; (6) Having a pacemaker.
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 | NL82723.028.23 |