TIMELY: a Patient-centred Lifestyle Program for Patients With Coronary Artery Disease

Summary

Study design: A randomized controlled trial will be used, where patients will be randomized (1:1) to either the control group receiving usual care or the intervention group in which patients will receive usual care in combination with the TIMELY intervention for a duration of 6 months.

Study sample: Female and male patients aged 18 years or over, with documented stable CAD and referred for cardiac rehabilitation (at \> 2 weeks but \<10 weeks after PCI or \>4 weeks but \<12 weeks after CABG or MI: STEM or non-STEMI), and/or having documented CAD by coronary angiography (stenosis in a major coronary artery \>50%).

Intervention: Patients randomized to the intervention group will receive the TIMELY app on their phones or tablets for 6 months. Patients will also receive a wearable activity tracker that collects activity levels, heart rate and sleep characteristics. Based on patient's activity levels, self-reported momentary mental states, health-related behaviors and environmental and clinical background factors, the app will enable patient-tailored recommendations relevant to improving lifestyle behaviors during daily life. In addition, patients will receive a blood pressure monitor that measures hemodynamic parameters through pulse wave analysis and an easy-to-use ECG device which will be used to assess changes in heart rate and other cardiovascular measures at rest and with exercise.

Main study parameters/endpoints: The primary biomedical outcome is a change in the CoroPredict biomarker risk score from baseline (pre-randomization) to completion of the active intervention phase (6 months). The CoroPredict score is an indicator of the 10-year risk of mortality. The primary behavioral outcome is the change from baseline to 6 months in patients' functional status of fitness level (measured using the 6-minute walk test). The study further aims to improve secondary outcome measures: physical activity levels during daily life and cardiovascular responses to exercise, dietary habits, smoking behavior, medication adherence and perceived levels of psychological stress.

Conditions

• Myocardial Infarction
• Coronary Artery Disease

Interventions

OTHER

TIMELY

The TIMELY app works with several devices, including a wearable activity tracker that collects activity levels, heart rate and sleep characteristics. Based on patient's activity levels, self-reported momentary mental states, health-related behaviours and environmental and clinical background factors, the app will enable patient-tailored recommendations relevant to improving lifestyle behaviours during daily life. In addition, patients will receive a blood pressure monitor that measures hemodynamic parameters through pulse wave analysis (PWA) and an easy-to-use ECG device which will be used to assess changes in heart rate and other cardiovascular measures at rest and with exercise.

Sponsors & Collaborators

• Klinik Königsfeld, Ennepetal, Germany

  collaborator UNKNOWN

• Servicio Gallego de Salud

  collaborator OTHER_GOV

• Tilburg University

  lead OTHER

Principal Investigators

• Jos Bosch, PhD · University of Amsterdam

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-14

Primary Completion

2025-05-07

Completion

2025-05-07

Countries

• Germany
• Netherlands
• Spain

Study Locations