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Make my Day - Primary Prevention of Stroke

Primary Purpose

Non-Communicable Diseases, Stroke, Cardiovascular Risk Factor

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Prevention program for stroke
Sponsored by
Emelie Malstam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-Communicable Diseases focused on measuring Life style, Primary prevention, Modifiable risk factors, mHealth, Engaging occupation

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Persons with increased risk for stroke according to Stroke risk score card
  • Persons motivated for participating in a digital lifestyle prevention (including the use of a mobile phone with the function to download and use apps),
  • Persons over 45 years

Exclusion Criteria:

  • Persons having had a stroke or TIA
  • Persons with a diagnosis of dementia or cognitive impairment

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prevention treatment group

Standard treatment group

Arm Description

Prevention program with 10 week blended intervention utilizing both a digital health app, group-sessions with peers and a interprofessional team of health-care workers chairing 5+1 themed group-sessions as support to change lifestyle habits in to a pattern of activities (behaviors and actions) in everyday life that can promote health and wellbeing and decrease risk for stroke. Lifestyle analysis and stroke risk screening before, at follow up and 12 months after the prevention program.

Usal care in Swedish primary health care. In addition a Lifestyle analysis and stroke risk screening before, at follow up and 12 months after the prevention program.

Outcomes

Primary Outcome Measures

Stroke risk score card
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.
Healthy Activity patterns (PPR profile)
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.
Questions of Lifestyle habits
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.
Canadian Occupational Performance Measurement (COPM)
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 Outcome Measures

Weight
Measure in kilograms with a scale. Measure includes observation of changes.
Blood pressure
Measure systolic and diastolic blood pressure with blood pressure machine. Measure includes observation of changes.
Occupational Balance (OBQ4)
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.
Motivation for lifestyle changes
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.
Lisat-11
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.
EQ5D
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.

Full Information

First Posted
October 29, 2018
Last Updated
March 16, 2023
Sponsor
Emelie Malstam
Collaborators
University of Gavle
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1. Study Identification

Unique Protocol Identification Number
NCT03730701
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emelie Malstam
Collaborators
University of Gavle

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Communicable Diseases, Stroke, Cardiovascular Risk Factor
Keywords
Life style, Primary prevention, Modifiable risk factors, mHealth, Engaging occupation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevention treatment group
Arm Type
Experimental
Arm Description
Prevention program with 10 week blended intervention utilizing both a digital health app, group-sessions with peers and a interprofessional team of health-care workers chairing 5+1 themed group-sessions as support to change lifestyle habits in to a pattern of activities (behaviors and actions) in everyday life that can promote health and wellbeing and decrease risk for stroke. Lifestyle analysis and stroke risk screening before, at follow up and 12 months after the prevention program.
Arm Title
Standard treatment group
Arm Type
No Intervention
Arm Description
Usal care in Swedish primary health care. In addition a Lifestyle analysis and stroke risk screening before, at follow up and 12 months after the prevention program.
Intervention Type
Behavioral
Intervention Name(s)
Prevention program for stroke
Intervention Description
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 Outcome Measure Information:
Title
Stroke risk score card
Description
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.
Time Frame
Baseline, within a month after the intervention, 1 year follow-up after baseline.
Title
Healthy Activity patterns (PPR profile)
Description
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.
Time Frame
Baseline, within a month after the intervention, 1 year follow-up after baseline.
Title
Questions of Lifestyle habits
Description
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.
Time Frame
Baseline, within a month after the intervention, 1 year follow-up after baseline.
Title
Canadian Occupational Performance Measurement (COPM)
Description
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.
Time Frame
Baseline, within a month after the intervention, 1 year follow-up after baseline.
Secondary Outcome Measure Information:
Title
Weight
Description
Measure in kilograms with a scale. Measure includes observation of changes.
Time Frame
Baseline, within a month after the intervention, 1 year follow-up after baseline.
Title
Blood pressure
Description
Measure systolic and diastolic blood pressure with blood pressure machine. Measure includes observation of changes.
Time Frame
Baseline, within a month after the intervention, 1 year follow-up after baseline.
Title
Occupational Balance (OBQ4)
Description
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.
Time Frame
Baseline, within a month after the intervention, 1 year follow-up after baseline.
Title
Motivation for lifestyle changes
Description
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.
Time Frame
Baseline, within a month after the intervention, 1 year follow-up after baseline.
Title
Lisat-11
Description
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.
Time Frame
Baseline, within a month after the intervention, 1 year follow-up after baseline.
Title
EQ5D
Description
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.
Time Frame
Baseline, within a month after the intervention, 1 year follow-up after baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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
Karolinska Institutet
City
Huddinge
State/Province
Stockholms Län
ZIP/Postal Code
14183
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
derived

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Make my Day - Primary Prevention of Stroke

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