"Make my Day"- Incorporating Healthy Activity Patterns: A Person-centered, Digital Prevention Program to Support Health Among Persons at Risk for Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Healthy Activity patterns (PPR profile)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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),
排除标准
- •Persons having had a stroke or TIA
- •Persons with a diagnosis of dementia or cognitive impairment
- •Drug abuse
研究组 & 干预措施
Prevention treatment group
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.
干预措施: Prevention program for stroke (Behavioral)
Standard treatment group
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.
结局指标
主要结局
Healthy Activity patterns (PPR profile)
时间窗: 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.
Canadian Occupational Performance Measurement (COPM)
时间窗: 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.
Stroke risk score card
时间窗: 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.
Questions of Lifestyle habits
时间窗: 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: 1. I have never smoked 2. I have smoked but I have stoped 3. I smoke, but not daily 4. 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.
次要结局
- Motivation for lifestyle changes(Baseline, within a month after the intervention, 1 year follow-up after baseline.)
- EQ5D(Baseline, within a month after the intervention, 1 year follow-up after baseline.)
- Weight(Baseline, within a month after the intervention, 1 year follow-up after baseline.)
- Lisat-11(Baseline, within a month after the intervention, 1 year follow-up after baseline.)
- Blood pressure(Baseline, within a month after the intervention, 1 year follow-up after baseline.)
- Occupational Balance (OBQ4)(Baseline, within a month after the intervention, 1 year follow-up after baseline.)
研究者
Emelie Malstam
Principal Investigator, Doctoral candidate
Karolinska Institutet