Clinical trial NCT05279508: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Non-communicable Disease
Keywords: Primary prevention
Engaging everyday activities
Occupational therapy
Primary healthcare
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Forte
name: Region Stockholm
First posted: 2022-03-15
Enrollment: 122
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Risk for stroke
timeFrame: At baseline
measure: Risk for stroke
timeFrame: at 10week follow up
measure: Risk for stroke
timeFrame: At 12-month follow up
Secondary outcomes:
measure: Participation in engaging everyday activities
timeFrame: At baseline
measure: Participation in engaging everyday activities
timeFrame: At 10-week follow up
measure: Participation in engaging everyday activities
timeFrame: At 12-month follow up
measure: Self rated life satisfaction
timeFrame: At baseline
measure: Self rated life satisfaction
timeFrame: At 10-week follow up
measure: Self rated life satisfaction
timeFrame: At 12-month follow up
measure: Self rated health
timeFrame: At baseline
measure: Self rated health
timeFrame: At 10-week follow up
measure: Self rated health
timeFrame: At 12-month follow up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholms Sjukhem
Study officials:
affiliation: Karolinska Institutet
name: Ann-Helen Patomella, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.