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Make My Day - a Stroke Prevention Program

Primary Purpose

Stroke, Non-communicable Disease

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Make My Day - stroke prevention program
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Primary prevention, Engaging everyday activities, Occupational therapy, Primary healthcare

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Stockholms Sjukhem

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prevention treatment group

Standard treatment group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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
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
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
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
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
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

Full Information

First Posted
January 26, 2022
Last Updated
July 5, 2023
Sponsor
Karolinska Institutet
Collaborators
Forte, Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT05279508
Brief Title
Make My Day - a Stroke Prevention Program
Official Title
Make My Day: an eHealth Supported Stroke Prevention Program for Primary Health Care Preventing Stroke and Supporting Everyday Activities
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 9, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Forte, Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Non-communicable Disease
Keywords
Primary prevention, Engaging everyday activities, Occupational therapy, Primary healthcare

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator and assessor are blinded to randomization
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevention treatment group
Arm Type
Experimental
Arm 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.
Arm Title
Standard treatment group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Make My Day - stroke prevention program
Intervention Description
A stroke prevention program within primary healthcare
Primary Outcome Measure Information:
Title
Risk for stroke
Description
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.
Time Frame
At baseline
Title
Risk for stroke
Description
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.
Time Frame
at 10week follow up
Title
Risk for stroke
Description
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.
Time Frame
At 12-month follow up
Secondary Outcome Measure Information:
Title
Participation in engaging everyday activities
Description
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.
Time Frame
At baseline
Title
Participation in engaging everyday activities
Description
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.
Time Frame
At 10-week follow up
Title
Participation in engaging everyday activities
Description
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.
Time Frame
At 12-month follow up
Title
Self rated life satisfaction
Description
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
Time Frame
At baseline
Title
Self rated life satisfaction
Description
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
Time Frame
At 10-week follow up
Title
Self rated life satisfaction
Description
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
Time Frame
At 12-month follow up
Title
Self rated health
Description
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
Time Frame
At baseline
Title
Self rated health
Description
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
Time Frame
At 10-week follow up
Title
Self rated health
Description
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
Time Frame
At 12-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann-Helen Patomella, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stockholms Sjukhem
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33813996
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.
Results Reference
background
PubMed Identifier
31678952
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.
Results Reference
background
PubMed Identifier
34442105
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.
Results Reference
background
PubMed Identifier
33021851
Citation
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.
Results Reference
background

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Make My Day - a Stroke Prevention Program

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