Stroke Clinical Trial
Official title:
"Make my Day"- Incorporating Healthy Activity Patterns: A Person-centered, Digital Prevention Program to Support Health Among Persons at Risk for Stroke
Verified date | March 2023 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 31, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet | Huddinge | Stockholms Län |
Lead Sponsor | Collaborator |
---|---|
Emelie Malstam | University of Gavle |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Baseline, within a month after the intervention, 1 year follow-up after baseline. | |
Primary | 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. | Baseline, within a month after the intervention, 1 year follow-up after baseline. | |
Primary | 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. |
Baseline, within a month after the intervention, 1 year follow-up after baseline. | |
Primary | 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. | Baseline, within a month after the intervention, 1 year follow-up after baseline. | |
Secondary | Weight | Measure in kilograms with a scale. Measure includes observation of changes. | Baseline, within a month after the intervention, 1 year follow-up after baseline. | |
Secondary | Blood pressure | Measure systolic and diastolic blood pressure with blood pressure machine. Measure includes observation of changes. | Baseline, within a month after the intervention, 1 year follow-up after baseline. | |
Secondary | 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. | Baseline, within a month after the intervention, 1 year follow-up after baseline. | |
Secondary | 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. |
Baseline, within a month after the intervention, 1 year follow-up after baseline. | |
Secondary | 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. | Baseline, within a month after the intervention, 1 year follow-up after baseline. | |
Secondary | 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. | Baseline, within a month after the intervention, 1 year follow-up after baseline. |
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