Stroke Clinical Trial
Official title:
Make My Day: an eHealth Supported Stroke Prevention Program for Primary Health Care Preventing Stroke and Supporting Everyday Activities
Verified date | July 2023 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Stockholms Sjukhem | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Forte, Region Stockholm |
Sweden,
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
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 |
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