Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
11000 participants
INTERVENTIONAL
2022-04-06
2028-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Usage of tool
Participants get access to the tool and use it regularly
Lifestyle tool
Regular use of the digital Lifestyle tool
Controls on usual care
Participants who get randomized to control cannot access the tool. Development of cardiovascular disease is followed via clinical registries.
No interventions assigned to this group
Interventions
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Lifestyle tool
Regular use of the digital Lifestyle tool
Eligibility Criteria
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Inclusion Criteria
* myocardial infarction within one year prior to enrolment
* access to computer or mobile phone.
Exclusion Criteria
35 Years
80 Years
ALL
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Anders Rosengren, Professor
Role: PRINCIPAL_INVESTIGATOR
Göteborg University
Locations
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Skane University Hospital
Malmo, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Lifestyle3
Identifier Type: -
Identifier Source: org_study_id
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