Effectiveness of Stroke Riskometer Apps In Improving Awareness and Stroke Risk Probability

Stroke Clinical Trial

Official title:

Effectiveness of Stroke Riskometer Apps In Improving Awareness of Stroke Risk and Stroke Risk Probability Among Young Adult Population In Kelantan: An App-Based Intervention Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04529681
• Other study ID #: NMRR-19-3296-51864(IIR)
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: May 2021

Study information

• Verified date: February 2021
• Source: Ministry of Health, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: May 2021
• Est. primary completion date: September 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• All consented young adult (aged 18 - 50 years old) who are Kelantan resident, can understand Malay language and own a smartphone.

Exclusion Criteria:

• Non-Malaysian and ever diagnosed of stroke and psychiatric problem.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Risk Factor, Cardiovascular
• Stroke

Intervention

Device:
• Stroke Riskometer Application
Mobile phone application uses to measure, monitor and manage, it mainly calculates the stroke risk probability within 5 year and 10 years by providing the absolute risk and relative risk which is compared to the normal healthy people with the same age and gender. Not only that, the application purposes to increase general awareness about stroke and its risk factors, and to improve stroke and heart attack prevention on an individual level.

Other:
• Informational Leaflets
Informational leaflets consist of the stroke-related leaflet, CVDs-related leaflet and the healthy eating behaviors including; disease introduction, what are the risk factors, early symptoms and also the preventive measures. These materials were developed and published by health education and promotion division Ministry of Health, Malaysia in 2013 - 2016. Usually it will be distributed to public during health screening program and also can be found at all healthcare facilities. All materials were in Malay language only.

Locations

Country	Name	City	State
Malaysia	Universiti Sains Malaysia, Health Campus	Kubang Kerian	Kelantan

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Health, Malaysia	Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke Risk Awareness	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).	6 weeks
Secondary	Body Mass Index (kg/m^2)	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.	6 weeks
Secondary	Blood Pressure (mmHg)	The outcome will be measured at the earlier of study and sixth week of study using uniform and well-calibrated instruments.	6 weeks
Secondary	Stroke Risk Probability	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).	6 weeks