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NCT Number: NCT05309876

Secondary Prevention With the Lifestyle Tool

In this study participants will be randomized to use a digital lifestyle tool over three years or to a control group without access to the tool. The investigators will prospectively follow the incidence of major cardiovascular events in patients who have previously suffered from a myocardial infarction in those using the tool regularly and those in the control group.

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Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skane University Hospital

Malmö, 20502, Sweden

Location status: Recruiting

Location contact

Anders Rosengren

CONTACT

[email protected]

About this study

Cardiovascular disease (CVD) remains a leading cause of death in most European countries, and new strategies for prevention are urgently needed.

Previous studies on primary and secondary prevention have shown that lifestyle interventions can affect risk factors for CVD and reduce cardiovascular morbidity and mortality. Many prevention programmes are, however, time-limited and fail to provide continuous support. They also require substantial costs and healthcare resources. Furthermore, accessibility to primary and secondary cardiac prevention programmes is highly variable, as is long-term adherence to lifestyle advice.

In light of this, international associations have emphasized the need for innovative, scalable and cost-effective lifestyle interventions that could be integrated into pre-existing healthcare structures. Digital tools have large potential for clinical utility, but there are several important knowledge gaps. First, data on long-term efficacy is scarce. Second, most studies to date have included only small number of individuals, and there is a need for large randomized controlled studies. Third, cost-effectiveness remains to be demonstrated.

The objective or this study is to evaluate a new web-based tool, developed at the University Gothenburg, Sweden, that aims to support patient autonomy and motivation to make sustainable lifestyle changes.

In individuals who have previously suffered from a myocardial infarction the investigators will test the hypothesis that those who access to the tool have lower incidence of further major cardiovascular events (MACE) compared with control individuals.

The study is an investigator-initiated single-center study conducted over three years.

The tool is web-based and used via a computer or mobile phone. It is used at each individual's preferred pace but participants are recommended to login at least every other week. Every round the participants choose a themes (out of appr. 80 possible covering e.g. food, exercise, stress, self-reflection aspects), which takes appr. 15-30 minutes to complete. Participants then reflect on the content and how it could be implemented in daily life. When returning for next round participants are asked to reflect on any changes done since last time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 35 to 80 years
  • myocardial infarction within one year prior to enrolment
  • access to computer or mobile phone.

Exclusion criteria

  • conditions or treatments that in the judgement of the Investigator could affect the study evaluation

Treatment and study plan

Lifestyle tool

Behavioral

Regular use of the digital Lifestyle tool

Primary outcomes

  1. Incidence of major adverse cardiovascular event

    Time frame: 3 years

    Incidence of major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure compared between participants regularly using the tool and on usual care.

Study contacts

Contact information is provided by the study sponsor or research team.

Birgitta Abrahamsson

CONTACT

[email protected]

0705316704

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

Secondary Prevention of Cardiovascular Disease With the Lifestyle Tool

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Apr 4, 2022
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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