Effectiveness of Stroke Riskometer Apps In Improving Awareness and Stroke Risk Probability
1 other identifier
interventional
116
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Aug 2020
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2020
CompletedFirst Posted
Study publicly available on registry
August 28, 2020
CompletedStudy Start
First participant enrolled
August 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedFebruary 24, 2021
February 1, 2021
5 days
August 19, 2020
February 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Body Mass Index (kg/m^2)
6 weeks
Blood Pressure (mmHg)
6 weeks
Stroke Risk Probability
6 weeks
Study Arms (2)
Intervention Group
EXPERIMENTALIntervention 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
OTHERControl 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- All consented young adult (aged 18 - 50 years old) who are Kelantan resident, can understand Malay language and own a smartphone.
You may not qualify if:
- Non-Malaysian and ever diagnosed of stroke and psychiatric problem.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ministry of Health, Malaysialead
- Universiti Sains Malaysiacollaborator
Study Sites (1)
Universiti Sains Malaysia, Health Campus
Kubang Kerian, Kelantan, 16150, Malaysia
Related Publications (1)
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.
PMID: 34535608DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamad Zarudin M Said, MD, MPH
Universiti Sains Malaysia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 19, 2020
First Posted
August 28, 2020
Study Start
August 31, 2020
Primary Completion
September 5, 2020
Study Completion
May 1, 2021
Last Updated
February 24, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share