Clinical trial NCT05309876: Secondary Prevention With the Lifestyle Tool
Official title: Secondary Prevention of Cardiovascular Disease With the Lifestyle Tool
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 11000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants get access to the tool or get assigned to a control group without access
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of major adverse cardiovascular event
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Skane University Hospital
Study officials:
affiliation: Göteborg University
name: Anders Rosengren, Professor
role: PRINCIPAL_INVESTIGATOR
References: