Secondary Prevention With the Lifestyle Tool

Cardiovascular Diseases Clinical Trial

Official title:

Secondary Prevention of Cardiovascular Disease With the Lifestyle Tool

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05309876
• Other study ID #: Lifestyle3
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2022
• Source: Region Skane
• Contact: Birgitta Abrahamsson
• Phone: 0705316704
• Email: birgitta.x.abrahamsson[@]skane.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Lifestyle tool
Regular use of the digital Lifestyle tool

Locations

Country	Name	City	State
Sweden	Skane University Hospital	Malmo

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major adverse cardiovascular event	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.	3 years