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Completed

NCT Number: NCT03730701

Make my Day - Primary Prevention of Stroke

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.

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Key information

Conditions

Non-communicable Diseases Brain Diseases Cardiovascular Diseases Cardiovascular Risk Factor Central Nervous System Diseases Cerebrovascular Disorders Disease Attributes Nervous System Diseases Noncommunicable Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Huddinge, Stockholm County, 14183, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevention program for stroke

Behavioral

The prevention program include individual and group intervention sessions supported by a digital platform. The program will be personally tailored in relation to what the person needs and what to change and the individuals rediness for change. The digital platform will support the person during and in between sessions by prompting goals and goal-fulfilment, logging activities, step counts and provide a forum for sharing and reflection.

Primary outcomes

  1. Stroke risk score card

    Time frame: Baseline, within a month after the intervention, 1 year follow-up after baseline.

    Through the stroke risk score card estimate change in risk for Stroke and how high this risk are.

    Three colums with different colours. Red, yellow and green. Red is High risk, Yellow is Caution, and Green is Low risk. In total there is 8 points per column.

    High risk: >3 red points: Ask about stroke prevention right away. Caution: 4-6: A good start. Work on reducing risk. Low risk: 6-8: You're doing very well at controlling stroke risk.

  2. Healthy Activity patterns (PPR profile)

    Time frame: Baseline, within a month after the intervention, 1 year follow-up after baseline.

    PPRP (Daily Experiences of Pleasure, Productivity, and Restoration Profile) is a activity-diary where change is meant to be measured regarding activity patterns in everyday life. Experiences are scored as 1-7 in four domains (Pleasure, Productivity, Restoration and Health promotion). For example the domain of health promotion is scored as 1 (very unhealthy) to 7 (very healthy) in regards to different engagements in everyday life. The higher the value the better.

  3. Questions of Lifestyle habits

    Time frame: Baseline, within a month after the intervention, 1 year follow-up after baseline.

    Measuring change in lifestyle habits with a self-percieved questionnaire with open questions and estimations of different lifestyle habits in everyday life regarding dietary, smoking, alcohol, physical activity habits.

    Participants selects an option on each question or writes an estimated number or answer on what and how they usually do regarding each lifestyle habit.

    For example if they are or have been smoking and how much.

    Example of answers options:

    • I have never smoked
    • I have smoked but I have stoped
    • I smoke, but not daily
    • I smoke daily.....X cigarettes a day. Where answer 4. is worse than answer 1.

    And on alcohol consumption. Question: How many standard glases do you drink a normal week? Answer with a self-percieved number, no fixed response options.

  4. Canadian Occupational Performance Measurement (COPM)

    Time frame: Baseline, within a month after the intervention, 1 year follow-up after baseline.

    COPM is a client-centered, semi-structured interview assessment that enables the person to identify and prioritize areas of improvement in everyday life. To support goal-setting, defined areas is scored between 0-10 guiding prioritizations of areas of which is scored in regards to performance and satisfaction, also scored between 0-10. Where a higher value is better experience of performance and satisfaction of occupations. Mean change will be measured.

Secondary outcomes

  1. Weight

    Time frame: Baseline, within a month after the intervention, 1 year follow-up after baseline.

    Measure in kilograms with a scale. Measure includes observation of changes.

  2. Blood pressure

    Time frame: Baseline, within a month after the intervention, 1 year follow-up after baseline.

    Measure systolic and diastolic blood pressure with blood pressure machine. Measure includes observation of changes.

  3. Occupational Balance (OBQ4)

    Time frame: Baseline, within a month after the intervention, 1 year follow-up after baseline.

    Self-percieved questionnaire of balance in and between occupations in everyday life. 13 questions. Answers between 1-4 where 1 is Do not agree at all, And 4 is Agree very much. Measure includes observation of changes. Where a higher value is better.

  4. Motivation for lifestyle changes

    Time frame: Baseline, within a month after the intervention, 1 year follow-up after baseline.

    Measure motivation for lifestyle changes with questionnare on a scale from 1 to 5 where 1 is does not fit at all and 5 is fits very well.

    Points:

    20 - 25 points: High level of motivation for change. 15 - 20 points: Moderat level of motivation to change. 10 - 15 points: Low level of motivation to change. Below 10 points: Very low motivation to change.

    The higher value the better. Measure includes observation of changes.

  5. Lisat-11

    Time frame: Baseline, within a month after the intervention, 1 year follow-up after baseline.

    Questionnaire on Life satisfaction with 11 questions with a scale 1-6. 1 means unsatisfied and 6 means very satisfied. Where a higher value is better. Measure includes observation of changes.

  6. EQ5D

    Time frame: Baseline, within a month after the intervention, 1 year follow-up after baseline.

    Questionnaire of Quality of Life with two different parts. Part one includes 5 domains scored from 1 to 3, where a higher value is worse. For example "worry/depression" 1. I am not worried/depressed) 2. I am worried or depressed to some degree. 3. I am very much worried and/or depressed. The second part is a VAS-scale from 1 to 100, where a higher value is better state of health. Measures includes observation of changes.

Sponsors and collaborators

Lead sponsor

Emelie Malstam

Other

Collaborators

  • University of Gavle

Registry information

Official study title

"Make my Day"- Incorporating Healthy Activity Patterns: A Person-centered, Digital Prevention Program to Support Health Among Persons at Risk for Stroke

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2018
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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