Secondary Prevention With the Lifestyle Tool

NCT05309876 | Recruiting

• 1 other identifier: Lifestyle3
• Study Type: interventional
• Target: 11,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Usage of tool

EXPERIMENTAL

Participants get access to the tool and use it regularly

Behavioral: Lifestyle tool

Controls on usual care

NO INTERVENTION

Participants who get randomized to control cannot access the tool. Development of cardiovascular disease is followed via clinical registries.

Interventions

Lifestyle tool BEHAVIORAL

Regular use of the digital Lifestyle tool

Usage of tool

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skane University Hospital

Malmo, 20502, Sweden

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Anders Rosengren, Professor

  Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgitta Abrahamsson

CONTACT

0705316704; birgitta.x.abrahamsson@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants get access to the tool or get assigned to a control group without access

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: April 6, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after publication.
• Access Criteria: To researchers who provide a methodologically sound proposal in order to achieve the aims of that proposal. Proposals should be directed by email to internetverktyg@gu.se

Locations

SE (1)