Make My Day - a Stroke Prevention Program

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05279508
• Other study ID #: KI2020-00175
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 9, 2022
• Est. completion date: October 2024

Study information

• Verified date: July 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 122
• Est. completion date: October 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Non-communicable Disease
• Noncommunicable Diseases
• Stroke

Intervention

Behavioral:
• Make My Day - stroke prevention program
A stroke prevention program within primary healthcare

Locations

Country	Name	City	State
Sweden	Stockholms Sjukhem	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Forte, Region Stockholm

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Asaba E, Bergstrom A, Patomella AH, Guidetti S. Engaging occupations among persons at risk for stroke: A health paradox. Scand J Occup Ther. 2022 Feb;29(2):116-125. doi: 10.1080/11038128.2020.1829036. Epub 2020 Oct 6. — View Citation

Malstam E, Asaba E, Akesson E, Guidetti S, Patomella AH. 'Weaving lifestyle habits': Complex pathways to health for persons at risk for stroke. Scand J Occup Ther. 2022 Feb;29(2):152-164. doi: 10.1080/11038128.2021.1903991. Epub 2021 Apr 4. — View Citation

Patomella AH, Farias L, Eriksson C, Guidetti S, Asaba E. Engagement in Everyday Activities for Prevention of Stroke: Feasibility of an mHealth-Supported Program for People with TIA. Healthcare (Basel). 2021 Jul 30;9(8):968. doi: 10.3390/healthcare9080968. — View Citation

Patomella AH, Guidetti S, Malstam E, Eriksson C, Bergstrom A, Akesson E, Kottorp A, Asaba E. Primary prevention of stroke: randomised controlled pilot trial protocol on engaging everyday activities promoting health. BMJ Open. 2019 Nov 2;9(11):e031984. doi: 10.1136/bmjopen-2019-031984. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk for stroke	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.	At baseline
Primary	Risk for stroke	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.	at 10week follow up
Primary	Risk for stroke	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.	At 12-month follow up
Secondary	Participation in engaging everyday activities	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.	At baseline
Secondary	Participation in engaging everyday activities	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.	At 10-week follow up
Secondary	Participation in engaging everyday activities	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.	At 12-month follow up
Secondary	Self rated life satisfaction	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	At baseline
Secondary	Self rated life satisfaction	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	At 10-week follow up
Secondary	Self rated life satisfaction	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	At 12-month follow up
Secondary	Self rated health	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	At baseline
Secondary	Self rated health	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	At 10-week follow up
Secondary	Self rated health	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	At 12-month follow up