TIMELY: A patient-centred lifestyle program to support the continuum of care in patients with coronary artery disease using eHealth and artificial intelligence

Conditions: coronary artery disease
heart disease
ischemic heart disease
10011082

Registration Number: NL-OMON53970

Lead Sponsor: niversiteit van Tilburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 120

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To investigate whether the TIMELY intervention is superior to usual care in<br /><br>terms of<br /><br>A) reducing the CoroPredict risk score (indicating risk of 10-year mortality:<br /><br>primary biomedical outcome) from baseline to six months; and<br /><br>B) increasing functional fitness levels (6-minute walk test) primary<br /><br>behavioural outcome) from baseline to 6 months</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The improvements under primary objectives are expected to be associated with<br /><br>improvements in the secondary outcomes:<br /><br>a. Physical activity levels and cardiovascular responses to exercise<br /><br>b. Healthy dietary habits<br /><br>c. Smoking cessation<br /><br>d. Medication adherence<br /><br>e. Reducing psychological stress levels<br /><br><br /><br>1. To investigate whether the TIMELY intervention is superior to care as usual<br /><br>in terms of improvement in physical and mental well-being and quality of life<br /><br>2. To investigate the feasibility and usability of the TIMELY intervention.<br /><br>3. To investigate whether the TIMELY intervention is superior to care as usual<br /><br>in terms of cost-effectiveness </p><br>