Clinical trial NCT03730701: Make my Day - Primary Prevention of Stroke
Official title: "Make my Day"- Incorporating Healthy Activity Patterns: A Person-centered, Digital Prevention Program to Support Health Among Persons at Risk for Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Communicable Diseases
Stroke
Cardiovascular Risk Factor
Keywords: Life style
Primary prevention
Modifiable risk factors
mHealth
Engaging occupation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: University of Gavle
First posted: 2018-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the feasibility of a digital, person-centered stroke prevention program with a focus on primary prevention. The program is aiming to enable lifestyle change and to promote healthy activity patterns to decrease risk factors for stroke and in that way prevent future stroke.

Detailed description: The study is a randomized controlled pilot trial evaluating the feasibility of a digitally augmented person-centered stroke prevention program with a focus on primary prevention. The program is aiming to enable lifestyle change and to promote healthy activity patterns to decrease risk factors for stroke and in that way prevent future stroke. With activity patterns (individual actions and behaviour) in everyday life we mean a persons overall lifestyle that may or may not contribute to health.

The prevention program is a theoretically grounded, complex intervention tested against a control-group that are receiving usual care. The prevention program is based on activities in people's everyday lives and integrates health and well-being with what people do, as well as with what they want or need to do, in order to thrive and live well. Lifestyle change refers to a conscious change of behaviour and everyday activities in order to promote health. The process of changing behaviour results from an interaction between the person (eg, self-efficacy), the environment (support and material) and the action. In the project, the key behavioural change technique is incorporating engaging everyday activities (EEAs) that contribute to a healthy lifestyle. This might include changing the form of current EEAs or finding new health-promoting EEAs.

Eligibility criteria: Inclusion Criteria:

* Persons with increased risk for stroke according to Stroke risk score card
* Persons motivated for participating in an intense digital lifestyle prevention (including the use of a mobile phone with the function to download and use apps),

Exclusion Criteria:

* Persons having had a stroke or TIA
* Persons with a diagnosis of dementia or cognitive impairment
* Drug abuse

Primary outcomes:
measure: Stroke risk score card
timeFrame: Baseline, within a month after the intervention, 1 year follow-up after baseline.
measure: Healthy Activity patterns (PPR profile)
timeFrame: Baseline, within a month after the intervention, 1 year follow-up after baseline.
measure: Questions of Lifestyle habits
timeFrame: Baseline, within a month after the intervention, 1 year follow-up after baseline.
measure: Canadian Occupational Performance Measurement (COPM)
timeFrame: Baseline, within a month after the intervention, 1 year follow-up after baseline.
Secondary outcomes:
measure: Weight
timeFrame: Baseline, within a month after the intervention, 1 year follow-up after baseline.
measure: Blood pressure
timeFrame: Baseline, within a month after the intervention, 1 year follow-up after baseline.
measure: Occupational Balance (OBQ4)
timeFrame: Baseline, within a month after the intervention, 1 year follow-up after baseline.
measure: Motivation for lifestyle changes
timeFrame: Baseline, within a month after the intervention, 1 year follow-up after baseline.
measure: Lisat-11
timeFrame: Baseline, within a month after the intervention, 1 year follow-up after baseline.
measure: EQ5D
timeFrame: Baseline, within a month after the intervention, 1 year follow-up after baseline.
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Institutet
state: Stockholms Län
Study officials:
affiliation: Karolinska Institutet
name: Ann-Helen Patomella, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.