Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000939796
Ethics application status
Approved
Date submitted
9/06/2022
Date registered
1/07/2022
Date last updated
1/07/2022
Date data sharing statement initially provided
1/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of an Individualised Intervention for the Prevention of Stroke (TIIPS)- using health and wellness coaching
Scientific title
Trial of an Individualised Intervention for the Prevention of Stroke (TIIPS)- the efficacy of health and wellness coaching in adults at risk of stroke after minor stroke and TIA
Secondary ID [1] 307155 0

Nil known
Universal Trial Number (UTN)
Trial acronym
TIIPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 326518 0
transient ischaemic attack (TIA) 326523 0
Condition category
Condition code
Neurological 323782 323782 0 0
Other neurological disorders
Stroke 324059 324059 0 0
Ischaemic
Stroke 324060 324060 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health and wellness coaching (HWC) intervention: HWC is a multidimensional psychological behaviour change intervention aimed at improving self-management of lifestyle behaviour and maintaining health and wellbeing. It fosters ongoing self-directed learning, delivering a cost-effective intervention in person or by telephone, and by medical or non-medical personnel, thus saving cost and increasing the scope of implementation. Individuals who receive HWC have increased perceived health status, improved medication adherence, and physical activity, with significantly improved health outcomes shown in patients following myocardial infarction. There is no prescribed level of participation engagement (as the aim is to self-empower the participant to make their own changes), but each session will allow the participant to set their own goals, which will be noted and discussed in the next session.

Research staff will attend an intensive 4-week coaching course, at Momentum Coaching (www.coachmomentum.co.nz), with two sessions in the first two weeks and 4 which includes training in core coaching competencies and code of ethics, developed by the International Coach Federation (ICF) to support greater understanding of the skills and approaches used in the coaching profession.
The initial intervention will occur after the baseline assessment, to ensure the participant meets all the study criteria, and to collect all baseline health information. Following this, the participant will be randomised, and be informed of their group allocation to HWC. The designated coach (matched to the participant by the coach trainer, based on health and demographic information), will contact the participant to make an appointment to have the first session in person, (usually at the participant's home). The first session is expected to last about 1 hour. After this, further appointments are made to have the remaining sessions by video call (Zoom, or other options that suit the participant). These sessions are expected to last about 30 minutes.
The intervention will combine educational material and intensive HWC coaching. The educational material is existing evidence-based information (booklets) on healthy eating guidelines for the prevention of cardiovascular disease including stroke, from the NZ Heart Foundation, Life After Stroke, an information guide on how to manage after stroke, including secondary prevention, from the New Zealand Stroke Foundation, and information about the Stroke Riskometer App, a free app that informs people about their personal risk of stroke, risk factors and how to manage them, including using goal setting and reminders, how to recognise stroke, and what to do if someone is having a stroke. No new material will be produced by the study team.
Participants allocated to the HWC group will have 12 individual coaching sessions over 6 months with trained HWC coaches, of which 4 sessions are carried out weekly, 6 sessions fortnightly and the remaining two sessions monthly. The initial two sessions and the final session will be conducted face-to-face and the remaining coaching sessions via telephone. Between the final coaching session and the 12-month assessment, HWC participants will receive a short monthly telephone call from their coach to encourage maintenance of behaviour change. Coaching sessions will take up to 1 hour initially, with later sessions lasting about 30 minutes. Interventional Group participants will be provided with tools to assist with behaviour changes.
The details of each session will be recorded in the study database (REDCap), (Session number, date, coach name etc, plus whether or not the session took place, and if missed, reasons for this). Coaches will also complete a self-evaluation form after each session on REDCap to evaluate and reflect on how each session went. Participants will also be invited to reflect on the sessions in an open format, which will be recorded on teh REDCap database.
Intervention code [1] 323700 0
Behaviour
Intervention code [2] 323880 0
Lifestyle
Intervention code [3] 323881 0
Prevention
Comparator / control treatment
Participants in the Control Group will not receive any HWC. Control group participants will only receive information as part of their usual care from their health professionals, and no materials will be provided from the study.
Control group
Active

Outcomes
Primary outcome [1] 331552 0
The primary end-point is a change in systolic blood pressure from Baseline, with the study powered to detect a mean difference of 6 mm Hg (SD±20 mm Hg) between HWC and UC groups at 6 months post-randomisation. Blood pressure will be measured using a sphygmomanometer. A total of three readings will be taken and the average of the last two will be used as the final value.
Timepoint [1] 331552 0
Assessments will take place at Baseline, then 3- monthly up to 12 months post-randomisation - the primary timepoint is at 6 months post-randomisation.
Secondary outcome [1] 410240 0
Blood pressure, using a sphygmomanometer
Timepoint [1] 410240 0
6-months post-randomisation
Secondary outcome [2] 411243 0
Change in the proportion of participants in ‘high’ and ‘intermediate’ to ‘low’ risk on the Life's Simple 7 (LS7)
Timepoint [2] 411243 0
6-months post-randomisation
Secondary outcome [3] 411244 0
Stroke risk from Stroke Riskometer app – 5- year absolute risk
Timepoint [3] 411244 0
6- and 12-months post-randomisation
Secondary outcome [4] 411245 0
Quality of life (EQ5D) at 6-months post-randomisation
Timepoint [4] 411245 0
6 months post randomisation
Secondary outcome [5] 411246 0
Stroke awareness (using a stroke awareness questionnaire)
Timepoint [5] 411246 0
6- and 12-months post randomisation
Secondary outcome [6] 411247 0
Cognitive assessment score (Montreal Cognitive Assessment)
Timepoint [6] 411247 0
6-months post randomisation
Secondary outcome [7] 411248 0
Medication adherence (Self-Efficacy For Appropriate Medication Use Scale (SEAMS)
Timepoint [7] 411248 0
3, 6, 9 and 12 months post randomisation
Secondary outcome [8] 411249 0
CVD adverse outcomes (fatal and nonfatal stroke, TIA, myocardial infarction and heart failure, death attributable to CVD) as a composite outcome. Outcomes will be assess by reviewing hospital clinical records
Timepoint [8] 411249 0
3, 6, 9 and 12 months post randomisation
Secondary outcome [9] 411250 0
Healthcare and community service costs assessed as self-reported service use questionnaire at follow up..
Timepoint [9] 411250 0
3, 6, 9, and 12 months post randomisation
Secondary outcome [10] 411379 0
All cause mortality
Timepoint [10] 411379 0
12 months post randomisation
Secondary outcome [11] 411380 0
Stroke risk from Stroke Riskometer app – 5- year relative risk
Timepoint [11] 411380 0
12 months post randomisation
Secondary outcome [12] 411381 0
Blood glucose using blood test
Timepoint [12] 411381 0
6 months post randomisation
Secondary outcome [13] 411382 0
Blood cholesterol using blood test
Timepoint [13] 411382 0
6 months post randomisation
Secondary outcome [14] 411383 0
Productivity status will be self-reported and will include items regarding status (e.g., paid work, voluntary work, homemaker, student, unemployed), hours (e.g., full/part time), compared to hospitalisation pre-stroke status
Timepoint [14] 411383 0
3, 6, 9 and 12 months post randomisation

Eligibility
Key inclusion criteria
1. People aged between 18 years and 75 years diagnosed with TIA or first-ever minor stroke (excluding SAH) (National Institutes of Health Stroke Scale (NIHSS) score less than or equal to 4) and/or modified Rankin Scale (mRS) score between 0-2 at discharge in the past 6 weeks
2. Admitted to one of the three Auckland based hospitals or primary care for minor stroke or TIA
3. With at least 2 modifiable risk factors
4. Who can converse in English
5. Provides written informed consent
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of major stroke or myocardial infarction (verified through Clinical Portal medical records)
2. Planned carotid endarterectomy
3. Life-threatening conditions with a life expectancy less than 5 years
4. Current (in the past year) significant clinical depression/anxiety (Hospital Anxiety and Depression questionnaire (HADS) greater than or equal to 11 in either or both the depression and anxiety domains) (either in clinical records or at screening) OR psychiatric conditions (based on medical records),
5. History (past year) of alcohol or drug/substance abuse
6. Dependent on others (living in a rest-home/care facility)
7. Significant cognitive impairment or pre-existing diagnosis of dementia e.g. ACE-R less than 82 (from clinical records), or at screening (MoCA (less than 26))
6. Participation in another RCT

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer over the RedCap software:

Randomisation will be conducted in REDCap. On completion of the baseline assessment, the study manager will randomise participants into HWC (N equal to =180) or UC (N equal to 180). The participant details will be anonymised, and will be assigned a unique study ID. All communication with health coaches and research assistants will utilise this unique ID. Only the study manager(s) will know the randomisation details and will keep them concealed.

Randomisation Procedure: The randomisation form in REDCap will be a hidden form, visible only to the study managers and data managers. The research assistants and the coaches will not have access to the randomisation form. The randomisation parameters will be predefined, the stratified randomisation module will be selected, and the strata will be selected as age (less than 55, equal to 55 years), sex (M, F); and ethnicity (European, Pacific, Maori, Asian and MELAA (Middle Eastern, Latin American and African). The Dashboard display will show the allocation as HWC or Usual Care (Control).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation: Stratified minimisation randomisation will be used to balance prognostic factors: age (less than 55, equal to 55 years, sex (Male, Female), ethnicity (European, Pacific, Maori, Asian and MELAA (Middle Eastern, Latin American and African).
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
Participants will be allocated to one of the following two groups:

1. Interventional Group
2. Control Group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculation: The sample of 360 participants will provide a simulated 90% statistical power (two-sided a=0.05, ß =0.10 ) to detect a clinically significant 6 mmHg (SD±20) difference in systolic blood pressure change at 6 months post-randomisation, assuming 20% non-compliance/loss to follow-up.

Based on our RIBURST data (an observational stroke risk study) data in NZ general population (n=1265, with 0.07% incident stroke or TIA), the required sample size (n=360) will also provide 90% power (2-sided alpha) to detect 20% relative risk reduction in 5-year absolute risk of stroke. The estimated 5-year risk of stroke after TIA and minor stroke in NZ appeared to be greater than that in Europe, likely due to the greater risk of stroke in Maori and Pacific's people constituting 20% of the NZ RIBURST Study population.

Descriptive analyses: These will be reported overall and compared between HWC and usual care groups using parametric and non-parametric techniques, depending on the distribution of the data. Means (95% CI), standard deviations, medians and quartiles will be reported for continuous risk factor variables while cross-tabulations will be reported for categorical risk factor variables.

Inferential analyses: Intention to treat (ITT) analyses and per-protocol analysis will be used. To address the primary hypothesis ANCOVA will be used to compare the difference in systolic blood pressure at 6-months post-randomisation between the HWC and usual care groups, accounting for baseline stratification factors: (age, gender and ethnicity), referral centres, geographical region and known influential clinical characteristics (e.g. comorbidities). To address the secondary hypotheses linear mixed-effects (LME) repeated measures models will be used to investigate the differences in (1) adherence to medication (2) health-related quality of life (3) incidence of new vascular events including death (4) life satisfaction (5) cognition (6) mood) and (7) health service utilisation costs between the HWC and Usual care groups, and by ethnicity (sub-group analysis) at 6-months (plus lifestyle and adherence at 1-year post-randomisation. These LMEs will model the effect of time (baseline, 3-, 6- 9- and 12-months (medication adherence, lifestyle and awareness at only 12 months), post-randomisation whilst accounting for key demographic stratification factors known to confound with outcomes. Any data not collected within 6-weeks of the follow-up points will be classified as missing data. Baseline covariates of age, sex, most recent blood pressure measurement and any additional variables predictive of outcome data will be included in the imputation model. The reasons for missingness and the reasons will be recorded and accounted for. Sensitivity analyses will be conducted to test the assumptions of the model (including a complete case analysis in which only subjects with complete data are included). Familywise error control will be used to account for the multiplicity of tests. Inferences will be based on a 5% significance level and two-sided alternatives.

For the analysis of - CVD adverse outcomes (fatal and nonfatal stroke, TIA, myocardial infarction and heart failure, death attributable to CVD and all-cause mortality), we will use the Kaplan-Meier life- test and estimate the hazard ratios (HR) and adjusted HR using time-to-event Cox regression analysis. Time to event analysis will include recurrent events and time-dependent variables where appropriate.
The competing risk method will also be applied to compare the CVD adverse outcomes between the two interventional groups, accounting for mortality outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/07/2022
Actual
Date of last participant enrolment
Anticipated
1/03/2024
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment outside Australia
Country [1] 24812 0
New Zealand
State/province [1] 24812 0
Auckland

Funding & Sponsors
Funding source category [1] 311459 0
Government body
Name [1] 311459 0
Health Research Council (HRC)
Country [1] 311459 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Auckland University of Technology
North Campus
90 Akoranga Drive
Northcote 0627
Auckland
New Zealand
Country
New Zealand
Secondary sponsor category [1] 312854 0
None
Name [1] 312854 0
Address [1] 312854 0
Country [1] 312854 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310929 0
Nothern Region Health and Disability Ethics Committee
Ethics committee address [1] 310929 0
Ethics committee country [1] 310929 0
New Zealand
Date submitted for ethics approval [1] 310929 0
17/03/2022
Approval date [1] 310929 0
01/06/2022
Ethics approval number [1] 310929 0
2022 EXP 12456

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119386 0
A/Prof Rita Krishnamurthi
Address 119386 0
Faculty of Health & Environmental Sciences
National Institute for Stroke and Applied Neurosciences
AUT University
North Shore Campus
Room AR414
90 Akoranga Drive
Northcote
Auckland 0627
Country 119386 0
New Zealand
Phone 119386 0
+6421556071
Fax 119386 0
Email 119386 0
[email protected]
Contact person for public queries
Name 119387 0
Rita Krishnamurthi
Address 119387 0
Faculty of Health & Environmental Sciences
National Institute for Stroke and Applied Neurosciences
AUT University
North Shore Campus
Room AR414
90 Akoranga Drive
Northcote
Auckland 0627
Country 119387 0
New Zealand
Phone 119387 0
+6421556071
Fax 119387 0
Email 119387 0
[email protected]
Contact person for scientific queries
Name 119388 0
Rita Krishnamurthi
Address 119388 0
Faculty of Health & Environmental Sciences
National Institute for Stroke and Applied Neurosciences
AUT University
North Shore Campus
Room AR414
90 Akoranga Drive
Northcote
Auckland 0627
Country 119388 0
New Zealand
Phone 119388 0
+6421556071
Fax 119388 0
Email 119388 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data will be managed by NISAN and stored at AUT University. AUT University follows a rigorous process where the data is stored, retained, and disposed of in an ethical manner. The information is required to be protected under the NZ Health Information Privacy Code 1994 and NZ Privacy Act 1993. Information will not be shared with any third party. The data will be kept for a period of 10 years. This is so that we can analyse this data and report it to the participants, agencies, and communities effectively. After 10 years all information will be destroyed by the study manager by deleting records on the REDCap database and shredding the paper copies. De-identified and aggregated data will be retained to conduct secondary analyses and for data pooling.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.