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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
21/12/2018
Date data sharing statement initially provided
21/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Would Knowing Your Risk For Getting Stroke Make You Change Your Lifestyle?
Scientific title
Influence of Stroke Riskometer on Making Lifestyle Changes Among Urban Dwelling Malaysian Stroke Caregivers: A Pilot Randomised Controlled Trial
Secondary ID [1] 296758 0
nil known
Universal Trial Number (UTN)
U1111-1224-8551
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 310676 0
Condition category
Condition code
Stroke 309356 309356 0 0
Ischaemic
Stroke 309445 309445 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 313067 0
Early detection / Screening
Intervention code [2] 313068 0
Lifestyle
Comparator / control treatment
Arm 2: Control
Allocated to intervention (n=40)
Calculate stroke risk using app. No application given to control group.

Control group
Active

Outcomes
Primary outcome [1] 308312 0
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.
Timepoint [1] 308312 0
3 months post commencement of stroke riskometer application.
Secondary outcome [1] 354632 0
To assess risk of stroke among stroke caregivers at 5 and 10 years in percentage using Stroke Riskometer.

Timepoint [1] 354632 0
3 months post commencement of stroke riskometer application
Secondary outcome [2] 354633 0
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.
Timepoint [2] 354633 0
3 months post commencement of stroke riskometer application

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21091 0
Malaysia
State/province [1] 21091 0
WILAYAH PERSEKUTUAN

Funding & Sponsors
Funding source category [1] 301337 0
University
Name [1] 301337 0
Universiti Kebangsaan Malaysia Fundamental Research Grant
Address [1] 301337 0
Jalan Yaacob Latif, Bandar Tun Razak, 56000 Batu 9 Cheras, Wilayah Persekutuan Kuala Lumpur
Country [1] 301337 0
Malaysia
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia Fundamental Research Grant
Address
Jalan Yaacob Latif, Bandar Tun Razak, 56000 Batu 9 Cheras, Wilayah Persekutuan Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 301004 0
None
Name [1] 301004 0
Address [1] 301004 0
Country [1] 301004 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302077 0
Universiti Kebangsaan Malaysia Medical Ethical Committee
Ethics committee address [1] 302077 0
Jalan Yaacob Latif, Bandar Tun Razak, 56000 Batu 9 Cheras, Wilayah Persekutuan Kuala Lumpur
Ethics committee country [1] 302077 0
Malaysia
Date submitted for ethics approval [1] 302077 0
15/03/2018
Approval date [1] 302077 0
09/04/2018
Ethics approval number [1] 302077 0
UKM PP1/111/8/JEP-2018-039

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89046 0
A/Prof Dr. Aznida FIrzah Abdul Aziz
Address 89046 0
Department of Family Medicine, 14th floor, Pre clinical Building, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Batu 9 Cheras, Wilayah Persekutuan Kuala Lumpur
Country 89046 0
Malaysia
Phone 89046 0
603-9145 9455
Fax 89046 0
Email 89046 0
draznida@ppukm.ukm.edu.my
Contact person for public queries
Name 89047 0
A/Prof Dr. Aznida FIrzah Abdul Aziz
Address 89047 0
Department of Family Medicine, 14th floor, Pre clinical Building, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Batu 9 Cheras, Wilayah Persekutuan Kuala Lumpur
Country 89047 0
Malaysia
Phone 89047 0
603-9145 9455
Fax 89047 0
Email 89047 0
draznida@ppukm.ukm.edu.my
Contact person for scientific queries
Name 89048 0
A/Prof Dr. Aznida FIrzah Abdul Aziz
Address 89048 0
Department of Family Medicine, 14th floor, Pre clinical Building, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Batu 9 Cheras, Wilayah Persekutuan Kuala Lumpur
Country 89048 0
Malaysia
Phone 89048 0
603-9145 9455
Fax 89048 0
Email 89048 0
draznida@ppukm.ukm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 585 0
Informed consent form
Citation [1] 585 0
Link [1] 585 0
Email [1] 585 0
Other [1] 585 0
Type [2] 586 0
Other
Citation [2] 586 0
Link [2] 586 0
Email [2] 586 0
Other [2] 586 0
Data collection form
Type [3] 587 0
Ethical approval
Citation [3] 587 0
Link [3] 587 0
Email [3] 587 0
Other [3] 587 0
Type [4] 600 0
Study protocol
Citation [4] 600 0
Link [4] 600 0
Email [4] 600 0
Other [4] 600 0
Type [5] 601 0
Other
Citation [5] 601 0
Link [5] 601 0
Email [5] 601 0
Other [5] 601 0
Flow chart of study
Summary results
No Results