Make My Day - a Stroke Prevention Program

NCT05279508 | Completed

• 1 other identifier: KI2020-00175
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Non-communicable Disease

Keywords

Primary prevention; Engaging everyday activities; Occupational therapy; Primary healthcare

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (9)

• Participation in engaging everyday activities

  At baseline

• Participation in engaging everyday activities

  At 10-week follow up

• Participation in engaging everyday activities

  At 12-month follow up

• Self rated life satisfaction

  At baseline

• Self rated life satisfaction

  At 10-week follow up

Study Arms (2)

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.

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.

Interventions

Make My Day - stroke prevention program BEHAVIORAL

A stroke prevention program within primary healthcare

Prevention treatment group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Forte: collaborator
• Region Stockholm: collaborator

Study Sites (1)

Stockholms Sjukhem

Stockholm, Sweden

Location

Related Publications (6)

• 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.

  PMID: 33813996 BACKGROUND

• 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.

  PMID: 31678952 BACKGROUND

• 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.

  PMID: 34442105 BACKGROUND

• 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.

  PMID: 33021851 BACKGROUND

• Patomella 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.

  PMID: 38056945 BACKGROUND

• Johnsson 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.

  PMID: 41178128 DERIVED

MeSH Terms

Conditions

Stroke; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann-Helen Patomella, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and assessor are blinded to randomization
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: March 15, 2022
• Study Start: April 9, 2022
• Primary Completion: April 17, 2024
• Study Completion: May 8, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)