Make my Day - Primary Prevention of Stroke

Emelie Malstam

Status: Completed

Conditions: Stroke; Cardiovascular Risk Factor; Non-Communicable Diseases

Treatments: Behavioral: Prevention program for stroke

Study type: Interventional

Funder types: Other

Identifiers

NCT03730701

MMDPrev1

Details and patient eligibility

About

The purpose of this study is to evaluate the feasibility of a digital, person-centered stroke prevention program with a focus on primary prevention. The program is aiming to enable lifestyle change and to promote healthy activity patterns to decrease risk factors for stroke and in that way prevent future stroke.

Full description

The study is a randomized controlled pilot trial evaluating the feasibility of a digitally augmented person-centered stroke prevention program with a focus on primary prevention. The program is aiming to enable lifestyle change and to promote healthy activity patterns to decrease risk factors for stroke and in that way prevent future stroke. With activity patterns (individual actions and behaviour) in everyday life we mean a persons overall lifestyle that may or may not contribute to health.

The prevention program is a theoretically grounded, complex intervention tested against a control-group that are receiving usual care. The prevention program is based on activities in people's everyday lives and integrates health and well-being with what people do, as well as with what they want or need to do, in order to thrive and live well. Lifestyle change refers to a conscious change of behaviour and everyday activities in order to promote health. The process of changing behaviour results from an interaction between the person (eg, self-efficacy), the environment (support and material) and the action. In the project, the key behavioural change technique is incorporating engaging everyday activities (EEAs) that contribute to a healthy lifestyle. This might include changing the form of current EEAs or finding new health-promoting EEAs.

Enrollment: 30 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Persons with increased risk for stroke according to Stroke risk score card
• Persons motivated for participating in an intense digital lifestyle prevention (including the use of a mobile phone with the function to download and use apps),

Exclusion criteria

• Persons having had a stroke or TIA
• Persons with a diagnosis of dementia or cognitive impairment
• Drug abuse

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Prevention treatment group

Experimental group

Description:

Prevention program with 10 week blended intervention utilizing both a digital health app, group-sessions with peers and a interprofessional team of health-care workers chairing 5+1 themed group-sessions as support to change lifestyle habits in to a pattern of activities (behaviors and actions) in everyday life that can promote health and wellbeing and decrease risk for stroke. Lifestyle analysis and stroke risk screening before, at follow up and 12 months after the prevention program.

Treatment:

Behavioral: Prevention program for stroke

Standard treatment group

No Intervention group

Description:

Usal care in Swedish primary health care. In addition a Lifestyle analysis and stroke risk screening before, at follow up and 12 months after the prevention program.