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Completed

NCT Number: NCT05279508

Make My Day - a Stroke Prevention Program

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.

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Key information

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stockholms Sjukhem

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Make My Day - stroke prevention program

Behavioral

A stroke prevention program within primary healthcare

Primary outcomes

  1. Risk for stroke

    Time frame: At baseline

    Risk for stroke is measured with the Swedish version of the Stroke riskometer. The Stroke riskometer uses an algoritm to estimate the 5-year and 10-year stroke risk from multiple choice questions on lifestyle habits and medical history. The result is given in % for both 5-year and 10-year and higher % means higher risk.

  2. Risk for stroke

    Time frame: at 10week follow up

    Risk for stroke is measured with the Swedish version of the Stroke riskometer. The Stroke riskometer uses an algoritm to estimate the 5-year and 10-year stroke risk from multiple choice questions on lifestyle habits and medical history. The result is given in % for both 5-year and 10-year and higher % means higher risk.

  3. Risk for stroke

    Time frame: At 12-month follow up

    Risk for stroke is measured with the Swedish version of the Stroke riskometer. The Stroke riskometer uses an algoritm to estimate the 5-year and 10-year stroke risk from multiple choice questions on lifestyle habits and medical history. The result is given in % for both 5-year and 10-year and higher % means higher risk.

Secondary outcomes

  1. Participation in engaging everyday activities

    Time frame: At baseline

    Participation in engaging everyday activities measured with Canadian Occupational Performance Measure (COPM). Five activities are listed and performance and satisfaction are scored between 1-10. 1 means either not able to perform or not satisfied at all and 10 means either performs extremely well or extremely satisfied.

  2. Participation in engaging everyday activities

    Time frame: At 10-week follow up

    Participation in engaging everyday activities measured with Canadian Occupational Performance Measure (COPM). Five activities are listed and performance and satisfaction are scored between 1-10. 1 means either not able to perform or not satisfied at all and 10 means either performs extremely well or extremely satisfied.

  3. Participation in engaging everyday activities

    Time frame: At 12-month follow up

    Participation in engaging everyday activities measured with Canadian Occupational Performance Measure (COPM). Five activities are listed and performance and satisfaction are scored between 1-10. 1 means either not able to perform or not satisfied at all and 10 means either performs extremely well or extremely satisfied.

  4. Self rated life satisfaction

    Time frame: At baseline

    Self rated life satisfaction measured with LiSat-11. A questionnaire with 11 questions with a scale 1-6.

    1 means unsatisfied and 6 means very satisfied

  5. Self rated life satisfaction

    Time frame: At 10-week follow up

    Self rated life satisfaction measured with LiSat-11. A questionnaire with 11 questions with a scale 1-6.

    1 means unsatisfied and 6 means very satisfied

  6. Self rated life satisfaction

    Time frame: At 12-month follow up

    Self rated life satisfaction measured with LiSat-11. A questionnaire with 11 questions with a scale 1-6.

    1 means unsatisfied and 6 means very satisfied

  7. Self rated health

    Time frame: At baseline

    Self rated health measured with EQ-5D. A questionnaire on self rated health with question on 5 health defining domain with a scale 1-3. 1 means no problems and 3 means extreme problems. Also an analog scale (VAS) ranging 0-100. 100 means best possible health and 0 means worst possible health.

    1 means unsatisfied and 6 means very satisfied

  8. Self rated health

    Time frame: At 10-week follow up

    Self rated health measured with EQ-5D. A questionnaire on self rated health with question on 5 health defining domain with a scale 1-3. 1 means no problems and 3 means extreme problems. Also an analog scale (VAS) ranging 0-100. 100 means best possible health and 0 means worst possible health.

    1 means unsatisfied and 6 means very satisfied

  9. Self rated health

    Time frame: At 12-month follow up

    Self rated health measured with EQ-5D. A questionnaire on self rated health with question on 5 health defining domain with a scale 1-3. 1 means no problems and 3 means extreme problems. Also an analog scale (VAS) ranging 0-100. 100 means best possible health and 0 means worst possible health.

    1 means unsatisfied and 6 means very satisfied

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Forte
  • Region Stockholm

Registry information

Official study title

Make My Day: an eHealth Supported Stroke Prevention Program for Primary Health Care Preventing Stroke and Supporting Everyday Activities

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2022
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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