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Trial registered on ANZCTR
Registration number
ACTRN12618002050235
Ethics application status
Approved
Date submitted
1/12/2018
Date registered
21/12/2018
Date last updated
22/11/2022
Date data sharing statement initially provided
21/12/2018
Date results information initially provided
17/11/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
Would Knowing Your Risk For Getting Stroke Make You Change Your Lifestyle?
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Scientific title
Influence of Stroke Riskometer on Making Lifestyle Changes Among Urban Dwelling Malaysian Stroke Caregivers: A Pilot Randomised Controlled Trial
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Secondary ID [1]
296758
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nil known
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Universal Trial Number (UTN)
U1111-1224-8551
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
310676
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Condition category
Condition code
Stroke
309356
309356
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0
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Ischaemic
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Stroke
309445
309445
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0
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Haemorrhagic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
313067
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Early detection / Screening
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Intervention code [2]
313068
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Lifestyle
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Comparator / control treatment
Arm 2: Control
Allocated to intervention (n=40)
Calculate stroke risk using app. No application given to control group.
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Control group
Active
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Outcomes
Primary outcome [1]
308312
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To determine feasibility of the intervention of using Stroke Riskometer Application in influencing lifestyle changes in stroke caregivers. Feasibility of the studies is measured by willingness of participants to be recruited and randomised (number=n), number of eligible carers, follow up rate, time needed to collect data.
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Assessment method [1]
308312
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Timepoint [1]
308312
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3 months post commencement of stroke riskometer application.
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Secondary outcome [1]
354632
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To assess risk of stroke among stroke caregivers at 5 and 10 years in percentage using Stroke Riskometer.
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Assessment method [1]
354632
0
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Timepoint [1]
354632
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3 months post commencement of stroke riskometer application
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Secondary outcome [2]
354633
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To determine the lifestyle changes of stroke caregivers within 3 months after knowledge of personal stroke risk assessed by Stroke Riskometer as measured by Life’s Simple 7 questionnaire.
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Assessment method [2]
354633
0
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Timepoint [2]
354633
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3 months post commencement of stroke riskometer application
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2019
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Actual
3/12/2018
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Date of last participant enrolment
Anticipated
31/01/2019
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Actual
31/01/2019
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Date of last data collection
Anticipated
6/05/2019
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Actual
6/06/2019
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Sample size
Target
80
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Accrual to date
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Final
75
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Recruitment outside Australia
Country [1]
21091
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Malaysia
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State/province [1]
21091
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WILAYAH PERSEKUTUAN
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Funding & Sponsors
Funding source category [1]
301337
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University
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Name [1]
301337
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Universiti Kebangsaan Malaysia Fundamental Research Grant
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Address [1]
301337
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Jalan Yaacob Latif, Bandar Tun Razak, 56000 Batu 9 Cheras, Wilayah Persekutuan Kuala Lumpur
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Country [1]
301337
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Malaysia
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Primary sponsor type
University
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Name
Universiti Kebangsaan Malaysia Fundamental Research Grant
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Address
Jalan Yaacob Latif, Bandar Tun Razak, 56000 Batu 9 Cheras, Wilayah Persekutuan Kuala Lumpur
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Country
Malaysia
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Secondary sponsor category [1]
301004
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None
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Name [1]
301004
0
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Address [1]
301004
0
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Country [1]
301004
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302077
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Universiti Kebangsaan Malaysia Medical Ethical Committee
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Ethics committee address [1]
302077
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Jalan Yaacob Latif, Bandar Tun Razak, 56000 Batu 9 Cheras, Wilayah Persekutuan Kuala Lumpur
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Ethics committee country [1]
302077
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Malaysia
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Date submitted for ethics approval [1]
302077
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15/03/2018
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Approval date [1]
302077
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09/04/2018
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Ethics approval number [1]
302077
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UKM PP1/111/8/JEP-2018-039
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Dr. Aznida FIrzah Abdul Aziz
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Address
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Department of Family Medicine, 14th floor, Pre clinical Building, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Batu 9 Cheras, Wilayah Persekutuan Kuala Lumpur
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Country
89046
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Malaysia
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Phone
89046
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603-9145 9455
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Fax
89046
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Email
89046
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[email protected]
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Contact person for public queries
Name
89047
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A/Prof Dr. Aznida FIrzah Abdul Aziz
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Address
89047
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Department of Family Medicine, 14th floor, Pre clinical Building, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Batu 9 Cheras, Wilayah Persekutuan Kuala Lumpur
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Country
89047
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Malaysia
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Phone
89047
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+603 91456117
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Fax
89047
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Email
89047
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[email protected]
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Contact person for scientific queries
Name
89048
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A/Prof Dr. Aznida FIrzah Abdul Aziz
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Address
89048
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Department of Family Medicine, 14th floor, Pre clinical Building, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Batu 9 Cheras, Wilayah Persekutuan Kuala Lumpur
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Country
89048
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Malaysia
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Phone
89048
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+603 91456117
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Fax
89048
0
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Email
89048
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
585
Informed consent form
376497-(Uploaded-04-12-2018-00-23-37)-Study-related document.docx
586
Other
Data collection form
376497-(Uploaded-04-12-2018-00-24-25)-Study-related document.docx
587
Ethical approval
376497-(Uploaded-04-12-2018-00-25-39)-Study-related document.pdf
600
Study protocol
376497-(Uploaded-04-12-2018-00-28-45)-Study-related document.docx
601
Other
Flow chart of study
376497-(Uploaded-04-12-2018-00-29-16)-Study-related document.docx
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Basic results
No
376497-(Uploaded-20-11-2022-20-17-39)-Basic results summary.pdf
Documents added automatically
No additional documents have been identified.
Download to PDF