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Would Knowing Your Risk For Getting Stroke Make You Change Your Lifestyle?

Influence of Stroke Riskometer on Making Lifestyle Changes Among Urban Dwelling Malaysian Stroke Caregivers: A Pilot Randomised Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618002050235
Enrollment
75
Registered
2018-12-21
Start date
2018-12-03
Completion date
2019-01-31
Last updated
2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A prospective randomised controlled trial is proposed among primary caregivers of post stroke patients, currently receiving treatment at a public university primary health care centre in Kuala Lumpur, Malaysia. All adult caregivers aged more than 18 years old, owns and able to operate a smartphone and literate in either English or Malay will be included. Caregivers who are either pregnant or diagnose or receiving treatment for depression or their care recipient resides in a nursing home will be excluded. Baseline stroke risk and current lifestyle practices will be recorded using Stroke RIskometer Application(SRA) and LIfe' s Simple 7 (LS7) questionnaire. Subject will be randomised to receive either additional acces to the Stroke RIskometer Application or without. Changes in SRA and LS7 scores will be measured together with clinical parameters.

Interventions

The intervention tool used in this study is a validated Stroke Riskometer application which can be downloaded for free via iOS and Google Play. The app contains 20 questions specifically designed to assess participant’s’ modifiable and non-modifiable risk factors. The application is available in English and Bahasa Malaysia version. Data obtained through the application will be recorded in google form. The collected data will be grouped into 3(three) domains; • Part A: Non modifiable risk fact

The intervention tool used in this study is a validated Stroke Riskometer application which can be downloaded for free via iOS and Google Play. The app contains 20 questions specifically designed to assess participant’s’ modifiable and non-modifiable risk factors. The application is available in English and Bahasa Malaysia version. Data obtained through the application will be recorded in google form. The collected data will be grouped into 3(three) domains; • Part A: Non modifiable risk factors: age, gender and race • Part B: Modifiable risk factors: Smoking status, excessive alcohol consumption, physical activities, healthy diet, family history of stroke, diabetes, Hypertension, atrial fibrillation, dementia. • Part C: Percentage of stroke risk calculated in 5 and 10 years of time. At initial assessment, all participants will be doing the questions in the application with assistance from researcher. Their risk of getting stroke for the next 5 and 10 years time will be informed and standard medical care will be given if they are at risk. Standard medical care is defined as treatment provided at primary care level according to Malaysian's Guideline such as hypertension, dyslipidemia, obesity, smoking dependance, atrial fibrillation, depression, dementia. Treatment of standard medical care will be given at primary care clinic by registered doctors. Upon entering the trial, only participants in the intervention group (n=40 ) will be receiving Stroke Riskometer application downloaded into their smartphones on which they are able to reuse and recorded. There's no time limit for participants. They will be assessed of their lifestyle according to Life's Simple 7 questions. Participants in control group will act upon their known risk of getting stroke independantly. They will not have any access or exposure to the Stroke Riskometer Application. Both control and interventional group will be assessed again after 12 weeks of trial and analysed the data obtained. Permission to use the Stroke Riskometer Application has been obtained from the original copyright owner of the app i.e Professor Valerie Feigin from Auckland University of Technology's, National Institute for Stroke and Applied Neurosciences. A list of all the stroke patients attending Post Stroke Clinic in Klinik Primer, will be used as the sampling frame. Potential participants will be identified via simple random sampling method and picked by using computer generated random number. They will be approached through phone call and if they agree to join, an appointment will be set up to assess their eligibility and to get consent. Caregivers who meet the inclusion criteria will be approached during their visit to the Klinik Primer with the patient and recruited for the trial. Consent will be taken and they will be briefed regarding the study protocol. They will also be informed regarding the randomization for intervention types in the study. Due to the nature of the intervention, participants will not be blinded to the type of intervention received during the trial. Participants who agree to participate in this trial will be asked to sign a written consent during interview the participants’ mental health status will be screened using Two Question With Help Question. If found to have symptoms of depression, they will then be referred to the primary care team for further evaluation and necessary treatment. Findings of the study and the feedback will be offered to the participants upon completion of the study. It will be emphasized that this study is totally voluntary and no discrimination will be given if they refuse to take part in this study. Similarly if they do agree to participate, they are free to withdraw at any time during the study if they change their mind.

Sponsors

Universiti Kebangsaan Malaysia Fundamental Research Grant
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

i. Aged at or more than 18 years old. ii. Owns a smartphone and knows how to use it. iii. Able to read and speak either in Bahasa Malaysia or English. iv. Stroke caregivers

Exclusion criteria

i. The care recipient i.e. post stroke patient resides in nursing home. ii. Pregnant caregivers. Enrolling pregnant mother to this trial for intervention and advices might affect their own health and the unborn foetus for example encouraging on low calorie diet or moderate intensity exercise. As some pregnancy might be entered in different trimester, their baseline assessment of weight, blood pressure, cholesterol will be remarkably different due to hormonal and physiological changes. iii. Stroke caregivers with possible depression (i.e. Respondents with positive score on the Two Question With Help Questionnaire i.e. a screening tool for depression

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026