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StrokeNCT04529681

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

A study testing Stroke Riskometer Application and Informational Leaflets in people with Stroke and Cardiovascular Diseases, run by Ministry of Health, Malaysia at 1 site in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
Stroke Riskometer Application and Informational Leaflets
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteMalaysia
Study dates
31 Aug 2020to May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Universiti Sains Malaysia, Health Campus

    Kubang Kerian, Kelantan, 16150

Other trials in Malaysia

About this study

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

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.

Read the 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.

Being tested
Stroke Riskometer Application, Informational Leaflets
Keywords
Stroke, Cardiovascular Diseases, Risk Probability, Awareness, Mobile Apps
Medical subject headings
Stroke, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stroke Riskometer ApplicationDevice

    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 LeafletsOther

    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.

Study groups in NCT04529681
Study groupRoleWhat they receive
Intervention GroupExperimentalIntervention 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.
Receives: Device: Stroke Riskometer Application; Other: Informational Leaflets
Control GroupOtherControl 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.
Receives: Other: Informational Leaflets

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 6 weeks

Secondary outcomes (3)

  1. 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.

    Measured: 6 weeks

  2. Blood Pressure (mmHg)

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

    Measured: 6 weeks

  3. 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).

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2020
  2. Study start31 Aug 2020
  3. Primary completion5 Sep 2020
  4. Study completionMay 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04529681
Sponsor's protocol ID
NMRR-19-3296-51864(IIR)
Status last verified
Feb 2021
First submitted
19 Aug 2020
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34535608

Questions about this trial

What is this clinical trial studying?

A study testing Stroke Riskometer Application and Informational Leaflets in people with Stroke and Cardiovascular Diseases, run by Ministry of Health, Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke Risk Awareness (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04529681, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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