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

Primary Purpose

Stroke, Cardiovascular Diseases, Risk Factor, Cardiovascular

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Stroke Riskometer Application
Informational Leaflets
Sponsored by
Ministry of Health, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Stroke, Cardiovascular Diseases, Risk Probability, Awareness, Mobile Apps

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Universiti Sains Malaysia, Health Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention Group

Control Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Blood Pressure (mmHg)
The outcome will be measured at the earlier of study and sixth week of study using uniform and well-calibrated instruments.
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).

Full Information

First Posted
August 19, 2020
Last Updated
February 22, 2021
Sponsor
Ministry of Health, Malaysia
Collaborators
Universiti Sains Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04529681
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
September 5, 2020 (Actual)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Malaysia
Collaborators
Universiti Sains Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cardiovascular Diseases, Risk Factor, Cardiovascular
Keywords
Stroke, Cardiovascular Diseases, Risk Probability, Awareness, Mobile Apps

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Stroke Riskometer Application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Informational Leaflets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stroke Risk Awareness
Description
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).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Body Mass Index (kg/m^2)
Description
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.
Time Frame
6 weeks
Title
Blood Pressure (mmHg)
Description
The outcome will be measured at the earlier of study and sixth week of study using uniform and well-calibrated instruments.
Time Frame
6 weeks
Title
Stroke Risk Probability
Description
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).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Zarudin M Said, MD, MPH
Organizational Affiliation
Universiti Sains Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Sains Malaysia, Health Campus
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34535608
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.
Results Reference
derived

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

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