StrokeNCT05279508
Make My Day - a Stroke Prevention Program
A study testing Make My Day - stroke prevention program in people with Stroke and Non-communicable Disease, run by Karolinska Institutet at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Stroke, Non-communicable Disease
- What is being tested?
- Make My Day - stroke prevention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSweden
- Study dates
- 9 Apr 2022to 8 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Make My Day: an eHealth Supported Stroke Prevention Program for Primary Health Care Preventing Stroke and Supporting Everyday Activities
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.
Read the detailed 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.
- Conditions
- Stroke, Non-communicable Disease
- Being tested
- Make My Day - stroke prevention program
- Keywords
- Primary prevention, Engaging everyday activities, Occupational therapy, Primary healthcare
- Medical subject headings
- Stroke, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Make My Day - stroke prevention programBehavioural
A stroke prevention program within primary healthcare
| Study group | Role | What they receive |
|---|---|---|
| Prevention treatment group | Experimental | 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. Receives: Behavioral: Make My Day - stroke prevention program |
| Standard treatment group | No intervention | Usual care within primary healthcare. At baseline, follow up and at 12 month follow up a lifestyle and stroke risk analysis will be conducted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
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.
Measured: at 10week follow up
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.
Measured: At 12-month follow up
Secondary outcomes (9)
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.
Measured: At baseline
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.
Measured: At 10-week follow up
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.
Measured: At 12-month follow up
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
Measured: At baseline
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
Measured: At 10-week follow up
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
Measured: At 12-month follow up
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
Measured: At baseline
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
Measured: At 10-week follow up
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
Measured: At 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start9 Apr 2022
- Primary completion17 Apr 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Forte, Region Stockholm
- Responsible party
- Principal investigator, Ann-Helen Patomella, Karolinska Institutet
- Investigators
- Ann-Helen Patomella, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279508
- Sponsor's protocol ID
- KI2020-00175
- Status last verified
- Jun 2024
- First submitted
- 26 Jan 2022
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33813996Patomella 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.
PubMed 31678952Patomella 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.
PubMed 34442105Asaba 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.
PubMed 33021851Patomella AH, Guidetti S, Hagstromer M, Olsson CB, Jakobsson E, Nilsson GH, Akesson E, Asaba E. Make My Day: primary prevention of stroke using engaging everyday activities as a mediator of sustainable health - a randomised controlled trial and process evaluation protocol. BMJ Open. 2023 Dec 6;13(12):e072037. doi: 10.1136/bmjopen-2023-072037.
PubMed 38056945Johnsson C, Asaba E, Guidetti S, Hagstromer M, Patomella AH. Performing lifestyle changes and reducing stroke risk: a process evaluation of a stroke prevention intervention. BMJ Open. 2026 Sep 30;16(9):e123012. doi: 10.1136/bmjopen-2026-123012.
PubMed 42816085Johnsson C, Asaba E, Guidetti S, Akesson E, Hagstromer M, Patomella AH. Make My Day - Stroke Prevention Grounded in Engaging Everyday Activities in Primary Healthcare - A Single-Blinded Randomised Controlled Trial. J Prim Care Community Health. 2025 Jan-Dec;16:21501319251385889. doi: 10.1177/21501319251385889. Epub 2025 Nov 2.
PubMed 41178128
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Make My Day: an eHealth Supported Stroke Prevention Program for Primary Health Care Preventing Stroke and Supporting Everyday Activities
- ClinicalTrials.gov ID
- NCT05279508
- Acronym / sponsor ID
- KI2020-00175
- Conditions
- Stroke, Non-communicable Disease
- Keywords
- Primary prevention, Engaging everyday activities, Occupational therapy, Primary healthcare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Forte, Region Stockholm
- Study start
- 9 Apr 2022 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention treatment group | Experimental | Behavioral: Make My Day - stroke prevention program10 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. |
| Standard treatment group | No intervention | –Usual care within primary healthcare. At baseline, follow up and at 12 month follow up a lifestyle and stroke risk analysis will be conducted. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Previously stroke or TIA
- Lack of understanding the Swedish language
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Make My Day - stroke prevention programA stroke prevention program within primary healthcare | Behavioural | Prevention treatment group |
Primary outcome
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.
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.
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.
9 secondary outcomes
Participation in engaging everyday activities
Time frame: At baseline
Participation in engaging everyday activities
Time frame: At 10-week follow up
Participation in engaging everyday activities
Time frame: At 12-month follow up
Self rated life satisfaction
Time frame: At baseline
Self rated life satisfaction
Time frame: At 10-week follow up
Self rated life satisfaction
Time frame: At 12-month follow up
Self rated health
Time frame: At baseline
Self rated health
Time frame: At 10-week follow up
Self rated health
Time frame: At 12-month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Background: PubMed 33813996Malstam 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.
- Background: PubMed 31678952Patomella 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.
- Background: PubMed 34442105Patomella 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.
- Background: PubMed 33021851Asaba 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.
- Background: PubMed 38056945Patomella AH, Guidetti S, Hagstromer M, Olsson CB, Jakobsson E, Nilsson GH, Akesson E, Asaba E. Make My Day: primary prevention of stroke using engaging everyday activities as a mediator of sustainable health - a randomised controlled trial and process evaluation protocol. BMJ Open. 2023 Dec 6;13(12):e072037. doi: 10.1136/bmjopen-2023-072037.
- Derived from this study: PubMed 42816085Johnsson C, Asaba E, Guidetti S, Hagstromer M, Patomella AH. Performing lifestyle changes and reducing stroke risk: a process evaluation of a stroke prevention intervention. BMJ Open. 2026 Sep 30;16(9):e123012. doi: 10.1136/bmjopen-2026-123012.
- Derived from this study: PubMed 41178128Johnsson C, Asaba E, Guidetti S, Akesson E, Hagstromer M, Patomella AH. Make My Day - Stroke Prevention Grounded in Engaging Everyday Activities in Primary Healthcare - A Single-Blinded Randomised Controlled Trial. J Prim Care Community Health. 2025 Jan-Dec;16:21501319251385889. doi: 10.1177/21501319251385889. Epub 2025 Nov 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann-Helen Patomella, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Make My Day - stroke prevention program in people with Stroke and Non-communicable Disease, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk for stroke (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05279508, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.