Effectiveness of Stroke Riskometer Apps In Improving Awareness and Stroke Risk Probability
- Conditions
- StrokeCardiovascular DiseasesRisk Factor, Cardiovascular
- Interventions
- Device: Stroke Riskometer ApplicationOther: Informational Leaflets
- Registration Number
- NCT04529681
- Lead Sponsor
- Ministry of Health, Malaysia
- Brief Summary
This intervention study using the Stroke Riskometer Apps as health promotion and disease prevention tools for the stroke prevention. Study will specifically target the young adult population (18-50 years old) who are the population at risk for young stroke. The study will determine the effectiveness of Stroke Riskometer Apps by assessing the awareness (knowledge, perception of stroke risk and intention to change behaviours) using the translated ABCD risk questionnaire and stroke risk probability using Stroke Riskometer Apps.
- Detailed Description
This intervention study is non-blinded, parallel-group cluster randomized controlled trial with 1:1 allocation ratio will be implemented in Kelantan, Malaysia with sample size of 58 each groups. The study will have four points of data collection (for ABCD risk questionnaire) in 6 weeks of intervention study. Primary outcome will be analysed using the Linear Mixed Effect model. Not only the effectiveness of Stroke Riskometer Apps, the investigators also able to get baseline stroke risk among young adult population in Kelantan, Malaysia. However, because of the time and budget limiting, the investigators only able to handle in Kelantan population and within 6 weeks duration.
This study will produce good impact; (a) targeting young adult population in response to young stroke incidence nationally and internationally, (b) tool that the investigators used will be a good starting to health promotion and disease prevention in Malaysia (model of valid and comparable stroke risk calculator, modules that used by Stroke Riskometer Apps), (c) comparing to current practices of non-communicable diseases (NCDs) prevention strategies - may need a practical and new effective strategy especially to catch up the newer generation at risk other than depending on health promotion and disease prevention program and leaflets promotion in health clinics.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 116
- All consented young adult (aged 18 - 50 years old) who are Kelantan resident, can understand Malay language and own a smartphone.
- Non-Malaysian and ever diagnosed of stroke and psychiatric problem.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Informational Leaflets Intervention group will be equipped with Stroke Riskometer Apps and informational leaflets. In the beginning of the study, investigators will guide the participants to download and install the Stroke Riskometer Apps and how to use the application to measure, monitor and self-manage the stroke risk. Participants will be followed up until six weeks with four points of data collection; baseline, second week, fourth week and sixth week. Intervention Group Stroke Riskometer Application Intervention group will be equipped with Stroke Riskometer Apps and informational leaflets. In the beginning of the study, investigators will guide the participants to download and install the Stroke Riskometer Apps and how to use the application to measure, monitor and self-manage the stroke risk. Participants will be followed up until six weeks with four points of data collection; baseline, second week, fourth week and sixth week. Control Group Informational Leaflets Control group will be given the informational leaflets consist of stroke-related leaflet, CVDs-related leaflet and the healthy eating behaviors. Participants will be followed up until six weeks with four points of data collection; baseline, second week, fourth week and sixth week.
- Primary Outcome Measures
Name Time Method Stroke Risk Awareness 6 weeks The outcome will be measured as stroke risk awareness score. The score will be calculated from the translated and validated 'Attitudes and Beliefs about Cardiovascular Disease (ABCD) Risk Questionnaire' which consists of 26 questions with total score of 80. The awareness score represents domain of knowledge (8 items), perception (12 items) and intention to change (6 items). For the domain knowledge, the type of answer is true/false/don't know while the rest are 4 likert scales; strongly disagree, disagree, agree and strongly agree. The total score will be calculated as percentage and the higher the percentage, the better the awareness of stroke risk. It will be assessed at the earlier of the study, second week, forth week and sixth week.
The outcome will be analysed using the Linear Mixed Effect model after adjusting the potential confounder such as sociodemographic (age, gender, ethnicity, marital status) and/or socioeconomic status (education level, income/occupational).
- Secondary Outcome Measures
Name Time Method Body Mass Index (kg/m^2) 6 weeks The outcome consists of weight (in kilogram) and height (in meters) that will be combined to report BMI in kg/m\^2. The BMI will be measured at the earlier of study and sixth week of study. Instruments that will be used in this study are uniform and well-calibrated.
Blood Pressure (mmHg) 6 weeks The outcome will be measured at the earlier of study and sixth week of study using uniform and well-calibrated instruments.
Stroke Risk Probability 6 weeks The outcome is the percentage of stroke risk probability within 5 and 10 years. It will be measured using the Stroke Riskometer (control group will use the same assessment that translated into question set). It contains 15 questions consist of stroke risk factors (smoking, alcohol consumption, dietary and physical activities), related comorbidity (diabetes, hypertension, heart disease and traumatic brain injury) and including the BMI and blood pressure. The higher the percentage of stroke risk probability means higher risk of getting stroke within 5 and 10 years. It will be measured on the baseline week and sixth week of the study.
The outcome will be analysed using the Linear Mixed Effect model between the intervention and control group. The model also will be adjusted to the potential confounder such as sociodemographic (age, gender, ethnicity, marital status) and/or socioeconomic status (education level, income/occupational).
Trial Locations
- Locations (1)
Universiti Sains Malaysia, Health Campus
🇲🇾Kubang Kerian, Kelantan, Malaysia