Make My Day - a Stroke Prevention Program

Karolinska Institute

Status: Completed

Conditions: Non-communicable Disease; Stroke

Treatments: Behavioral: Make My Day - stroke prevention program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05279508

KI2020-00175

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of a person-centered stroke prevention program implemented in primary healthcare. It is a primary prevention program aiming to reduce stroke risk and thereby prevent stroke through the enabling of lifestyle changes by introducing health beneficial engaging everyday activities promoting healthy activities and habits.

Full description

This study is a single-blind randomized control trial with the aim to evaluate the effects of a stroke prevention program, Make My Day (MMD), in comparison to ordinary primary healthcare services for people at risk for stroke. The MMD prevention program aims to reduce modifiable stroke risk factors and the future risk of stroke by introducing health beneficial engaging everyday activities enabling lifestyle changes and promoting healthy activity patterns and habits. It also includes a mHealth application consisting of six domains for registering daily activities, experiences and behaviours: Goal achievements, Physical activity, Engaging everyday activities, Tobacco and alcohol use, Stress levels and Dietary habits, to increase health literacy and awareness of current habits and to foster self-management.

Engaging everyday activities (EEA´s) are activities the person perceives as valuable, meaningful, and purposeful, as well as provide positive feelings and a sense of participation. EEA´s are performed regularly and are a part of a person's life and depending on the activity it may or may not contribute to health.

The MMD prevention program is person-centered group interventio with health professionals as interventionists. The program starts with an individual meeting at baseline with a lifestyle analysis that includes formulating individual activity goals. Follow-up assessment is done one week after the last group session. There are 6 group sessions where each session has a pre-set theme e.g. stroke risk, engaging everyday activities, physical activity, diet, life habits and routines. Five group-sessions will be conducted over a five week period with a booster session after another five weeks, in total 10 weeks.

The MMD prevention program is a theoretically grounded, complex intervention developed in accordance with the Medical Research Council (MRC) guidelines for developing complex interventions. And in line with the MRC guidelines a feasibility and pilot study have already been conducted. To enable reduction of stroke risk and achieve healthy lifestyle habits the MMD program uses strategies based on behavioural change theories. Behaviour change derives from the interaction process between the person, the environment, and the action. Key in the MMD-program is the incorporation of health beneficial EEA´s, either to incorporate new health beneficial EEA´s or to alter current non health beneficial EEA´s.

Enrollment: 122 patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Three or more high stroke risk factors on the Stroke Risk scorecard
• Motivated for lifestyle change
• Motivated for participating in a digital lifestyle prevention (including user of a smartphone or tablet)
• Between 55-75 years of age and without a diagnosis of dementia or cognitive impairment hindering participation

Exclusion criteria

• Previously stroke or TIA
• Lack of understanding the Swedish language

Other:

• All participants may choose to interrupt their participation in the study at any time.
• The researcher can also discontinue a participant's participation based on health issues or reasons that might jeopardize that person's safety. Reasons for interruption will be recorded.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 2 patient groups

Prevention treatment group

Experimental group

Description:

10 week stroke prevention program with six group sessions on pre-set themes targeting modifiable stroke risk factors . The group sessions are chaired by health professionals but also consists of peer learning to support change in lifestyle habits and activity patterns and reduce stroke risk. The change process is supported with a mHealth application for daily registrering of six domains; stroke risk factors, EEA, stress and goal achievement. A lifestyle and stroke risk analysis will be performed at baseline measures, at follow up and at 12 month follow up.

Treatment:

Behavioral: Make My Day - stroke prevention program

Standard treatment group

No Intervention group

Description:

Usual care within primary healthcare. At baseline, follow up and at 12 month follow up a lifestyle and stroke risk analysis will be conducted.