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

Ministry of Health, Malaysia

Status: Unknown

Conditions: Stroke; Cardiovascular Diseases; Risk Factor, Cardiovascular

Treatments: Other: Informational Leaflets; Device: Stroke Riskometer Application

Study type: Interventional

Funder types: Other

Identifiers

NCT04529681

NMRR-19-3296-51864(IIR)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Device: Stroke Riskometer Application

Other: Informational Leaflets

Control Group

Other group

Description:

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.

Treatment:

Other: Informational Leaflets