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

NCT05955625 | Completed

• 1 other identifier: NL82723.028.23
• Study Type: interventional
• Target: 358
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

Percutaneous coronary intervention; Coronary artery bypass graft; Lifestyle behaviour; Physical activity; Lifestyle intervention; Cardiac rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change in risk of mortality

  Risk of mortality will be determined using the validated biomarker risk score CoroPredict, indicating 10-year mortality probability.

  Baseline and 6 months

• Change in functional fitness levels

  Functional fitness levels will be assessed using the 6-minute walking test, using the number of meters walked as the outcome.

  Baseline and 6 months

Secondary Outcomes (7)

• Change in physical activity

  Baseline, 3 months and 6 months

• Change in cardiovascular exercise tolerance

  Baseline and 6 months

• Change in healthy dietary habits

  Baseline, 3 months and 6 months

• Change in weight

  Baseline and 6 months

• Change in smoking cessation

  Baseline, 3 months and 6 months

Study Arms (2)

TIMELY intervention and care as usual

EXPERIMENTAL

The intervention group will receive the TIMELY intervention including wearable monitoring devices and app in addition to care as usual for a duration of 6 months.

Other: TIMELY

Care as usual

NO INTERVENTION

The care as usual group will receive the standard care as they would receive without being enrolled in the current trial.

Interventions

TIMELY OTHER

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.

TIMELY intervention and care as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and over (there is no a priori upper age limit)
• 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: STEMI or non-STEMI) and/or having documented CAD by coronary angiography (stenosis in a major coronary artery \> 50%)
• Access and ability to operate a smartphone
• Able to speak the country's native language

You may not qualify if:

• Unable to fully understand the provided study information and consequences of participating in the study
• Presence of a physical impairment interfering with the use of the app or devices (e.g., blindness, wheelchair bound)
• Known diagnosis of an active malignant tumour (cancer) or any other medical condition associated with a life expectancy of less than one year
• Unstable cardiovascular, cerebrovascular or other unstable medical condition
• Refusal to informed consent
• Having a pacemaker

Sponsors & Collaborators

• Tilburg University: lead
• Klinik Königsfeld, Ennepetal, Germany: collaborator
• Servicio Gallego de Salud: collaborator

Study Sites (3)

Klinik Königsfeld

Ennepetal, Germany, 58256, Germany

Location

Willem Johan Kop

Tilburg, North Brabant, 5037 AB, Netherlands

Location

Hospital Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

Location

Related Publications (1)

• Habibovic M, Douma E, Schafer H, Sestayo-Fernandez M, Roovers T, Sun X, Schmidt H, Kotewitsch M, Widdershoven J, Cantarero-Prieto D, Mooren F, Pena-Gil C, Gonzalez Juanatey JR, Schmidt M, Malberg H, Tsakanikas V, Fotiadis D, Gatsios D, Bosch J, Kop WJ, Schmitz B. Patient-Centered Risk Prediction, Prevention, and Intervention Platform (TIMELY) to Support the Continuum of Care in Coronary Artery Disease Using eHealth and Artificial Intelligence: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 14;14:e66283. doi: 10.2196/66283.

  PMID: 40812736 DERIVED

Related Links

• Official website of the TIMELY project

MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease; Motor Activity

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Behavior

Study Officials

• Jos Bosch, PhD

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because this is a behavioral intervention, the participants and clinicians cannot be blinded to the treatment condition they are randomized to. However, the evaluation of the outcome measures will be done with researchers blinded to the treatment condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to two groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: July 14, 2023
• Primary Completion: May 7, 2025
• Study Completion: May 7, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); ES (1); DE (1)