Clinical trial NCT04529681: Effectiveness of Stroke Riskometer Apps In Improving Awareness and Stroke Risk Probability
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Cardiovascular Diseases
Risk Factor, Cardiovascular
Keywords: Stroke
Cardiovascular Diseases
Risk Probability
Awareness
Mobile Apps
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
Collaborators: name: Universiti Sains Malaysia
First posted: 2020-08-28
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stroke Risk Awareness
timeFrame: 6 weeks
Secondary outcomes:
measure: Body Mass Index (kg/m^2)
timeFrame: 6 weeks
measure: Blood Pressure (mmHg)
timeFrame: 6 weeks
measure: Stroke Risk Probability
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: Universiti Sains Malaysia, Health Campus
state: Kelantan
Study officials:
affiliation: Universiti Sains Malaysia
name: Mohamad Zarudin M Said, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mat Said Z, Musa KI, Tengku Ismail TA, Abdul Hamid A, Sahathevan R, Abdul Aziz Z, Feigin V. The Effectiveness of Stroke Riskometer in Improving Stroke Risk Awareness in Malaysia: A Study Protocol of a Cluster-Randomized Controlled Trial. Neuroepidemiology. 2021;55(6):436-446. doi: 10.1159/000518853. Epub 2021 Sep 15.