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Trial registered on ANZCTR


Registration number
ACTRN12621000211864
Ethics application status
Approved
Date submitted
26/10/2020
Date registered
1/03/2021
Date last updated
1/03/2021
Date data sharing statement initially provided
1/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of PERsonalised Knowledge to reduce the risk of Stroke (PERKS-International)
Scientific title
Evaluating the effect of PERsonalised Knowledge to reduce the risk of Stroke in at-risk adults (PERKS-International)
Secondary ID [1] 302536 0
None
Universal Trial Number (UTN)
U1111-1259-5819
Trial acronym
PERKS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 319405 0
cardiovascular disease 319406 0
Condition category
Condition code
Stroke 317374 317374 0 0
Ischaemic
Stroke 317375 317375 0 0
Haemorrhagic
Cardiovascular 317376 317376 0 0
Hypertension
Public Health 317377 317377 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group (IG) will be provided with written information on their risk factors and provided with the links to download the Stroke Riskometer App. The written information is structured around Life's Simple Seven - (i) blood pressure, (ii) cholesterol, (iii) blood sugar, (iv) being active, (v) eating well, (vi) BMI and (vii) smoking. Individual indicators for each factor will be measured by online questionnaire and face-to-face health assessment. The written materials have been developed for this study specifically.

The Stroke Riskometer App guides users to input their personal risk factors and uses an in-built validated algorithm to show the users' relative and absolute risk of stroke in the next 5 or 10 years. Information on risk factors is saved within the App to allow tracking over time. The App provides personalised feedback on a user's modifiable (e.g. lifestyle and biomedical) and unmodifiable (e.g. age and sex) risk factors for stroke including evidence-based information on how to manage these risk factors in text and video format. There is also information on the signs and symptoms of stroke based on the Face, Arm, Speech, Time (FAST) acronym. The App uses 'push notifications' that automatically communicate with the user about the App at a decreasing frequency from first app use (e.g. daily, then weekly, then monthly). The App can be used to set specific goals to change risk factors including monitoring of change.

Participants in the IG will complete a brief online questionnaire at 1 week after randomisation to confirm they have downloaded and entered their information into the app. The unblinded Project Manager will check-in with participants that do not complete the 1 week post-randomisation questionnaire or indicate that they are having issues with downloading or using the App. The App will be available to the Participants for the full 12 month duration of the trial, then indefinitely should they wish to continue to use the App.
Intervention code [1] 318822 0
Lifestyle
Comparator / control treatment
Participants in the usual care group (UCG) will receive written feedback on their risk factors without feedback on their risk of stroke and they will not be informed about the Stroke Riskometer App. The written information is structured around Life's Simple Seven - (i) blood pressure, (ii) cholesterol, (iii) blood sugar, (iv) being active, (v) eating well, (vi) BMI and (vii) smoking. Individual indicators for each factor will be measured by online questionnaire and face-to-face health assessment.
Control group
Active

Outcomes
Primary outcome [1] 325413 0
Change in total score on the combined health behaviour and biomedical cardiovascular risk factor score (Life's Simple 7)
Timepoint [1] 325413 0
6 months post-randomisation
Secondary outcome [1] 387847 0
Change in blood pressure. Blood pressure measured after 10 minutes of rest using a Omron digital blood pressure monitor and European Society for Cardiology guidelines.
Timepoint [1] 387847 0
6 months and 12 months post-randomisation
Secondary outcome [2] 387848 0
Change in awareness of stroke risk factors and warning signs. Participants will complete an online study-specific questionnaire on their knowledge of stroke.
Timepoint [2] 387848 0
6 months and 12 months post-randomisation
Secondary outcome [3] 387849 0
Change in health-related quality of life with the EQ5D.
Timepoint [3] 387849 0
6 months and 12 months post-randomisation
Secondary outcome [4] 387850 0
Change in the proportion of participants in 'high' and 'intermediate' risk on the combined health behaviour and biomedical cardiovascular risk factor score (Life's Simple 7)
Timepoint [4] 387850 0
6 months and 12 months post-randomisation
Secondary outcome [5] 387851 0
Change in the predicted 5-year risk of stroke from the Riskometer algorithm
Timepoint [5] 387851 0
6 months and 12 months post-randomisation
Secondary outcome [6] 387852 0
Cost-effectiveness of the Riskometer App in terms of health care use and costs from analysis of linked MBS/PBS data in Australia and equivalent data from New Zealand Ministry of Health.
Timepoint [6] 387852 0
6 months and 12 months post-randomisation
Secondary outcome [7] 387853 0
Participant satisfaction with the trial (study-specific questionnaire).
Timepoint [7] 387853 0
6 months and 12 months post-randomisation
Secondary outcome [8] 389416 0
Barriers and enablers of use of the Riskometer App for those in the intervention group (study-specific questionnaire and focus-groups)
Timepoint [8] 389416 0
6 months and 12 months post-randomisation
Secondary outcome [9] 391015 0
Change in smoking status. Change in smoking status will be determined with standardised questions on current smoking status comprising never (smoked<100 cigarettes/day), former (smoked>100 cigarettes/day and was regular smoker) and current regular (smoked>100 cigarette per day and currently smokes regularly - daily or most days). Changes between categories (never/former/current) will be calculated between baseline and follow-ups.
Timepoint [9] 391015 0
6 and 12 months post-randomisation
Secondary outcome [10] 391016 0
Change in BMI. Weight will be measured with Omron digital scale; height with a stadiometer. Changes in continuous BMI and categories of BMI will be used to examine the change between baseline and follow-up(s).
Timepoint [10] 391016 0
6 and 12 months post-randomisation
Secondary outcome [11] 391017 0
Change in diet. A brief Food Frequency Questionnaire (University of Leeds) will be used to calculate a diet quality score at baseline and follow-up. Changes in continuous ‘diet quality score’ and categories of ‘diet quality score’ (e.g. based on centiles) will be used to examine the change between baseline and follow-up(s).

Timepoint [11] 391017 0
6 and 12 months post-randomisation
Secondary outcome [12] 391018 0
Change in blood glucose. A capillary blood sample using a single-use lancet and capillary tube will be used with a Cardiochek point of care monitor to obtain non-fasting glucose. Changes in continuous glucose and clinically relevant categories of glucose will be used to examine the change between baseline and follow-up(s).
Timepoint [12] 391018 0
6 and 12 months post-randomisation
Secondary outcome [13] 391019 0
Change in total cholesterol. A capillary blood sample using a single-use lancet and capillary tube will be used with a Cardiochek point of care monitor to obtain total HDL and LDL cholesterol and triglyceride levels. Changes in continuous lipids and clinically relevant categories of lipids will be used to examine the change between baseline and follow-up(s).
Timepoint [13] 391019 0
6 and 12 months post-randomisation
Secondary outcome [14] 391021 0
Change in physical activity. The short version of the International Physical Activity Questionnaire (IPAQ) will be used to examine physical activity at baseline and follow-ups. Changes in continuous physical activity per week and clinically relevant categories of physical activity per week will be used to examine the change between baseline and follow-up(s).
Timepoint [14] 391021 0
6 and 12 months post-randomisation
Secondary outcome [15] 391022 0
Change in total score on the combined health behaviour and biomedical cardiovascular risk factor score (Life's Simple 7)
Timepoint [15] 391022 0
12 months post-randomisation

Eligibility
Key inclusion criteria
1. Adults aged between 35 years to 75 years;
2. with 2 or more ‘poor’ risk factors on the LS7 scale;
3. no cognitive impairment (as determined by MoCA, score >26)
4. own a Smartphone and are familiar with the use of mobile phone applications;
5. give informed consent to participate in the trial;
6. Speak English and able to understand requirements of the study and information provided through a mobile phone application.
Minimum age
35 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of stroke or myocardial infarction (self-report or verification through medical records when needed)
2. life-threatening conditions with a life-expectancy <5 years
3. participation in another RCT
4. family members of existing participants (or peers who reside in the same house).

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)
Allocation is concealed by randomisation by a central computer by a study staff member not involved in participant assessments
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use a computer-generated, block stratified randomisation procedure with location as the stratification factor to ensure that each site has a balance of participants in each group. The intervention will be randomly permuted within each block so that they are exactly balanced at the end of each block. No other stratification factors will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Assuming a 10% drop-out and 10% drop-in rate, 790 participants (395 IG, 395 UC) will provide 80% power (two sided a=0.05) to detect the difference found in the New Zealand pilot in the LS7 of around 0.40 (SD 1.61) in The App group compared to 0.01 (SD 1.44) in the UCG at 6 months post-randomisation. A pilot study recruited 68% of those screened, we estimate that we will need to screen 1,129 people to achieve the final sample of 790.
All analyses will be conducted using the principle of intention to treat (ITT) led by the study statistician. We will attempt to follow-up all randomised participants even if they withdraw from the allocated intervention. The main analyses will use Analysis of Covariance (ANCOVA) to address the primary hypothesis to compare the difference in change in LS7 at 6 months post-randomisation between the IG and UCGs. An overall LS7 score will be calculated and also categorized as inadequate (0-4), average (5-9), or optimum (10-14) cardiovascular health.
As per the ITT protocol, participants randomised and contributed at least one measure of an outcome will have their assessments deemed to belong to the ITT analysis set.
Pre-specified sub-group analyses will be conducted for the primary outcome only in order to assess whether there is effect modification by age, sex, residency, baseline 5 year absolute and relative CVD risk (as measured by the app), and socioeconomic status (as measured by family income).
Regression analysis models will be used to address the secondary hypotheses to investigate the difference in (1) the change in behavioural components of the LS7 score at 12 months; (2) level of stroke awareness; (3) identification of stroke warning signs; (4) quality of life; (5) health resource use and costs, between the IG and UCGs. Linear mixed effects models will be utilised to model the change in level of stroke awareness, identification of stroke warning signs, lifestyle behaviours, and quality of life measures between the IG and UCG from baseline, 3-, 6-, and 12-months post-randomisation. Maintenance of the intervention post the 6-month primary endpoint will be assessed using ANCOVA to model the change in behaviour (weight, diet, smoking, alcohol intake, physical activity) from 6 to 12 months. Inferences will be based on a 5% significance level and two-sided alternatives. The study reporting will follow the SPIRIT Guidelines for reporting the outcomes of an RCT.

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 in Australia
Recruitment state(s)
SA,TAS,VIC
Recruitment outside Australia
Country [1] 23062 0
New Zealand
State/province [1] 23062 0

Funding & Sponsors
Funding source category [1] 306973 0
Government body
Name [1] 306973 0
National Health and Medical Research Council
Address [1] 306973 0
16 Marcus Clarke St, Canberra ACT 2601
Country [1] 306973 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Medical Science Precinct, 17 Liverpool St, Hobart, Tasmania 7000
Country
Australia
Secondary sponsor category [1] 307533 0
None
Name [1] 307533 0
Address [1] 307533 0
Country [1] 307533 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307105 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 307105 0
301 Sandy Bay Road Sandy Bay TAS 7005
Ethics committee country [1] 307105 0
Australia
Date submitted for ethics approval [1] 307105 0
26/10/2020
Approval date [1] 307105 0
17/02/2021
Ethics approval number [1] 307105 0
23615

Summary
Brief summary
The PERKS-International trial, which has received funding from the Australian National Health and Medical Research Council (application ID APP1182071), will be of 4 years (2021-2024) duration and involve 790 participants who will be recruited and followed for at least 12 months. The Menzies Institute for Medical Research, University of Tasmania will be responsible for co-ordination of the PERKS-International trial.
This is a Phase III, prospective, pragmatic, open-label, single blinded endpoint 2 arm randomised controlled trial (RCT) including 790 participants across Australia and New Zealand. Participants will be adults aged >35 and <=75 years with two or more modifiable risk factors (smoking, overweight, low physical activity, poor diet, high blood pressure, high total cholesterol or high blood glucose). Participants will be randomised using a stratified block approach to either the intervention or usual care group. After undergoing a detailed health assessment, participants will be randomised to receive feedback on their risk factors for stroke in one of two ways. Our hypothesis is that those who receive feedback using one method (intervention group - IG) will have better improvements in their risk factors as compared to people who receive the information about their risk factors using the other method (usual care group - UCG). Blinded assessments will be conducted face-to-face at baseline and 6 months and by online or telephone assessment at 3 and 12 months. The primary outcome is the change in the total combined cardiovascular risk factor score (LS7 score) from baseline to 6 months post-randomisation in the intervention group compared to usual care group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106050 0
A/Prof Seana Gall
Address 106050 0
Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool St, Hobart, Tasmania 7000
Country 106050 0
Australia
Phone 106050 0
+61 362264728
Fax 106050 0
Email 106050 0
seana.gall@utas.edu.au
Contact person for public queries
Name 106051 0
A/Prof Seana Gall
Address 106051 0
Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool St, Hobart, Tasmania 7000
Country 106051 0
Australia
Phone 106051 0
+61 362264728
Fax 106051 0
Email 106051 0
seana.gall@utas.edu.au
Contact person for scientific queries
Name 106052 0
A/Prof Seana Gall
Address 106052 0
Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool St, Hobart, Tasmania 7000
Country 106052 0
Australia
Phone 106052 0
+61 362264728
Fax 106052 0
Email 106052 0
seana.gall@utas.edu.au

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
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 9448 0
Study protocol
Citation [1] 9448 0
Link [1] 9448 0
Email [1] 9448 0
seana.gall@utas.edu.au
Other [1] 9448 0
E-mail to the study principle investigator. Study protocol to be published prior to trial commencement.
Attachment [1] 9448 0
Type [2] 9449 0
Statistical analysis plan
Citation [2] 9449 0
Link [2] 9449 0
Email [2] 9449 0
seana.gall@utas.edu.au
Other [2] 9449 0
E-mail to the study principle investigator. Study protocol to be published prior to trial commencement.
Attachment [2] 9449 0
Type [3] 9450 0
Informed consent form
Citation [3] 9450 0
Link [3] 9450 0
Email [3] 9450 0
seana.gall@utas.edu.au
Other [3] 9450 0
Attachment [3] 9450 0
Type [4] 9451 0
Ethical approval
Citation [4] 9451 0
Link [4] 9451 0
Email [4] 9451 0
seana.gall@utas.edu.au
Other [4] 9451 0
Attachment [4] 9451 0
Summary results
No Results