Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001344381
Ethics application status
Approved
Date submitted
7/09/2017
Date registered
25/09/2017
Date last updated
17/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Supporting Lifestyle and Activity Modification after Transient Ischaemic Attack (TIA) (and mild stroke)
Scientific title
Effect of a behaviour change program on physical activity levels and blood pressure in people who have had a recent TIA or mild stroke
Secondary ID [1] 291935 0
None
Universal Trial Number (UTN)
Trial acronym
S+SLAM-TIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild stroke 303269 0
Transient Ischaemic Attack 303270 0
Condition category
Condition code
Stroke 302695 302695 0 0
Haemorrhagic
Stroke 302696 302696 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Service change and Supporting Lifestyle and Activity Modification after TIA (S+SLAM-TIA) is a non-randomised controlled trial which seeks to determine the effect participation in a 18 week behaviour change program has in increasing time spent in Moderate to Vigorous Physical Activity (MVPA) for the purpose of improving patient cardiovascular health.
The 18 week behaviour change program is currently delivered by the HNE LHD Community Stroke Team (CST). The 18 week program is designed to equip patients with knowledge, confidence and strategies to identify their modifiable risk factors for the purpose of changing health behaviours so as to improve their cardiovascular health and reduce the risk of cardiovascular events.
There are two phases to the program. The first phase involves 6 weeks of group education and exercise delivered in a community gym. Education sessions are conducted face-to-face by a CST clinician, once per week for 30 minutes. Content comprises of information about stroke etiology, risk factors for stroke, lifestyle changes to reduce the risk factors and practical goal setting. Exercise sessions are 1 hour in duration and conducted twice weekly for 6 weeks; the first 9 sessions are facilitated in person by a CST physiotherapist and exercise instructor and the final 3 sessions are independent exercise sessions with telehealth support. Participants complete 20-30 minutes of continuous cardiovascular exercise (treadmill, bike or rower) and functional strengthening (sit-to-stands, step ups, arm weights) with prompting to exercise at moderate intensity on the Borg RPE scale. Heart rate is also monitored to guide intensity of exercise – participants are encouraged to aim for 60-80% of their heart rate reserve. Group attendance is monitored by CST clinicians and any barriers to attending are addressed, using behaviour change methodology techniques if appropriate.
The second phase of the program is 12 weeks of fortnightly telehealth supported health coaching (5 sessions) delivered by HNE LHD Connecting Care via telephone with each individual. These sessions are approximately 15 minutes in duration. The purpose of the session is to discuss the participants goals and progress, discuss any barriers in achieving the goals and how to overcome these.
Usual care within this program is the collection of clinical outcomes at entry into the program (initial assessment/baseline) and at the end of both component one and two. Clinical outcomes are collected at baseline, 6, and 18 weeks.
All eligible patients participating in the SLAM-TIA program will be invited to participate in this research study as part of the intervention cohort. Control group participants will be recruited from a volunteer stroke register.
Outcomes collected for the research study, S+SLAM-TIA, running in parallel to the CST SLAM-TIA will be collected at HMRI in the Clinical Trials Unit, or at the Community Stroke Service, at entry into the program (baseline) and at the end of both component one and two (6 and 18 weeks). To evaluate the effectiveness of the program on achieving sustainable behaviour change, research outcomes will also be collected three months after the CST SLAM-TIA program has ceased (30 weeks).
Intervention code [1] 298111 0
Prevention
Intervention code [2] 298112 0
Lifestyle
Intervention code [3] 298113 0
Behaviour
Comparator / control treatment
Control group - no treatment.
Participants recruited from the Hunter Stroke Research Volunteer Register, and through flyers or word of mouth.
Control group
Active

Outcomes
Primary outcome [1] 302164 0
Average change in minutes per day spent in moderately vigorous physical activity (MVPA).
To evaluate this, participants wear an accelerometer for 1 week at baseline and at 6 weeks post-baseline.
Timepoint [1] 302164 0
6 weeks post-baseline
Primary outcome [2] 303325 0
Systolic Blood Pressure (SBP). Participants take twice daily home blood pressure measurements using an automatic blood pressure monitor for a 7 day period at baseline and 6 weeks post-baseline.
Timepoint [2] 303325 0
6 weeks post-baseline
Secondary outcome [1] 335023 0
MVPA between baseline and 18 weeks and baseline and 30 weeks. Participants wear an accelerometer for 1 week at each timepoint.
Timepoint [1] 335023 0
18 and 30 weeks
Secondary outcome [2] 335024 0
Systolic blood pressure between baseline and 18 weeks and baseline and 30 weeks


Timepoint [2] 335024 0
18 and 30 weeks
Secondary outcome [3] 337087 0
HbA1c level between baseline and 18 weeks and baseline and 30 weeks. This will be assessed through serum assay at each timepoint.

.
Timepoint [3] 337087 0
18 and 30 weeks
Secondary outcome [4] 338781 0
Body Mass Index calculated using weight and height.
Timepoint [4] 338781 0
6, 18 and 30 weeks
Secondary outcome [5] 338782 0
Waist:hip ratio using tape measure waist circumference and hip circumference.
Timepoint [5] 338782 0
6, 18 and 30 weeks.
Secondary outcome [6] 338783 0
Risk of cardiovascular event will be assessed using The Australian Type 2 Diabetes Risk Assessment Tool
Timepoint [6] 338783 0
30 weeks
Secondary outcome [7] 338784 0
Fatigue will be measured using the Fatigue Assessment Scale.
Timepoint [7] 338784 0
6, 18 and 30 weeks.
Secondary outcome [8] 338785 0
Cortisol levels will be measured by hair cortisol analysis (immunoassay analysis of hair samples).
Timepoint [8] 338785 0
18 and 30 weeks.
Secondary outcome [9] 338787 0
Cognitive function will be assessed using the following tools:
1. Picture Vocabulary Test
2. List Sorting Working Memory Test
3. Pattern Comparison Processing Speed Test
4. Auditory Verbal Learning Test
5. Oral Reading Recognition Test
6. Dimensional Change Card Sort Test
7. Flanker Inhibitory Control and Attention Test
Timepoint [9] 338787 0
6, 18 and 30 weeks
Secondary outcome [10] 338789 0
Submaximal exercise endurance will be measured using the 6 Minute Walk Test.
The 6 Minute Walk Test will be completed in intervention group only.
Timepoint [10] 338789 0
6, 18 and 30 weeks.
Secondary outcome [11] 338790 0
Grip strength will be assessed using a hand-grip dynamometer
Timepoint [11] 338790 0
6, 18 and 30 weeks.
Secondary outcome [12] 338791 0
Quality of life will be measured using the EuroQOL 5-D
Timepoint [12] 338791 0
6, 18 and 30 weeks
Secondary outcome [13] 338792 0
Depression, anxiety and stress levels will be measured using the Depression, Anxiety, Stress Scale (DASS)
Timepoint [13] 338792 0
6, 18 and 30 weeks.
Secondary outcome [14] 338793 0
Nutrition will be assessed using the self-reported Healthy Eating Questionnaire
Timepoint [14] 338793 0
6, 18 and 30 weeks
Secondary outcome [15] 338794 0
Smoking status will be evaluated by participant self-report. Patients will be asked if they smoke and how many cigarettes they smoke per day.
Timepoint [15] 338794 0
6, 18 and 30 weeks
Secondary outcome [16] 338795 0
Alcohol consumption will be evaluated using participant self-report. Participants will be asked if they drink and how many standard drinks they consume daily.
Timepoint [16] 338795 0
6, 18 and 30 weeks
Secondary outcome [17] 350768 0
Health Utilisation Cost: cost data will be accessed from the NSW Health Activity Based Funding Portal. Participants will also be asked to complete a Client Services Receipt Inventory.
Timepoint [17] 350768 0
Baseline, 6, 18 and 30 weeks
Secondary outcome [18] 350769 0
Attitudes to exercise: will be assessed via semi-structured interviews.
Timepoint [18] 350769 0
Baseline, 6, 18 and 30 weeks (intervention group)
Baseline and 18 weeks (control group)
Secondary outcome [19] 350770 0
Exercise Adopters Survey
Timepoint [19] 350770 0
Baseline

Eligibility
Key inclusion criteria
People with recent (within previous 3 months) TIA or mild stroke confirmed with MRI or clinical assessment as completed by treating stroke specialist
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with recent TIA or mild stroke who report to have a medical condition or chronic disease which prevents them from engaging in regular moderate to vigorous physical activity.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Non-randomised. Intervention cohort is recruited from patient group participating in an existing health service.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The co-primary outcomes will be the minutes per day spent in MVPA and systolic blood pressure (SBP) at 6 weeks. For both of these we will aim to detect 0.5SD difference (Cohen's d=0.5) between groups; this translates into a 15.5 minute difference in change in MVPA and a 9mmHg change in SBP. Assuming 80% power, adjusted p-value of 0.025 (to account for 2 primary outcomes), a t-test to look at change from baseline to 6 weeks between groups and allowing for a 10% dropout, the sample size needed will be 86 patients per group.

Secondary outcomes will look at trajectories over time (baseline, 6, 18 and 30 weeks) for MVPA, SBP and HbA1c using linear mixed models to handle repeated measures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/08/2017
Date of last participant enrolment
Anticipated
29/05/2020
Actual
Date of last data collection
Anticipated
18/12/2020
Actual
Sample size
Target
172
Accrual to date
38
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8040 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 16080 0
2305 - New Lambton
Recruitment postcode(s) [2] 16081 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 296442 0
Government body
Name [1] 296442 0
NSW Health Early-Mid Career Researcher Fellowship
Country [1] 296442 0
Australia
Primary sponsor type
Hospital
Name
Hunter Stroke Service, John Hunter Hospital
Address
Level 1
The Lodge
Rankin Park Centre
John Hunter Hospital
Lookout Road
New Lambton Heights
New South Wales
2305
Country
Australia
Secondary sponsor category [1] 295467 0
Other
Name [1] 295467 0
Hunter Medical Research Institute (HMRI)
Address [1] 295467 0
Kookaburra Crt
New Lambton Heights
NSW 2305
Country [1] 295467 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297672 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 297672 0
John Hunter Hospital
Lookout Road
New Lambton Heights
New South Wales
2305
Ethics committee country [1] 297672 0
Australia
Date submitted for ethics approval [1] 297672 0
31/05/2017
Approval date [1] 297672 0
19/07/2017
Ethics approval number [1] 297672 0
HREC/17/HNE/235

Summary
Brief summary
A TIA is a major warning sign for stroke. There is a 15% risk of stroke 90 days following initial event and the risk of cardiovascular events remains high 10-15 years post-TIA. It is best practice for TIA patients to receive secondary medical care to determine TIA cause and to commence preventative pharmacological therapy early post-event.

Behaviour change programs which include education and group exercise (ie. advice and support to address modifiable CVD risk factors including hypertension, inactivity, poor diet etc) significantly reduce the odds of further cardiovascular events. These programs significantly increase the time TIA patients spend in moderately vigorous physical activity (ie. brisk walking). The latter is extremely important as increasing physical activity independently contributes to significant reductions in cardiovascular risk, with an inverse relationship between time spent in moderately vigorous physical activity and risk of cardiovascular events and all-cause mortality.

Despite the evidence in support of the efficacy of behaviour change programs, TIA patients of Hunter New England Health Local Health District (HNE LHD) do not have access to an evidence based behaviour change program.

It is clear that there is an unmet need in this patient population. S+SLAM-TIA, Service change and Supporting Lifestyle and Activity Modification after Transient Ischemic Attack (S+SLAM-TIA), will address this service gap.

S+SLAM-TIA will bring together research active (i) stroke specialists and (ii) general practitioners (GPs), and the Community Stroke Team (CST) to embed a clinically feasible evidence based behaviour change program. This program will be delivered in a community gym and will be comprised of group education and exercise with the use of telehealth and telephone coaching.

S+SLAM-TIA aims to:

1. Evaluate the development and implementation of a behaviour change program for people who have had a recent TIA or minor stroke

2. Increase the minutes/week people who have had a recent TIA or minor stroke spend in moderately vigorous physical activity

3. Improve the cardiovascular health, well-being and quality of life of people who have had a recent TIA or minor stroke

4. Determine the cost-effectiveness of this new service including the health service and community cost-savings that increasing physical activity levels in this population brings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74766 0
Dr Heidi Janssen
Address 74766 0
Hunter Medical Research Institute
Kookaburra Circuit
New Lambton Heights
New South Wales
2305
Country 74766 0
Australia
Phone 74766 0
+612 40420000
Fax 74766 0
Email 74766 0
Heidi.Janssen@newcastle.edu.au
Contact person for public queries
Name 74767 0
Dr Heidi Janssen
Address 74767 0
Hunter Medical Research Institute
Kookaburra Circuit
New Lambton Heights
New South Wales
2305
Country 74767 0
Australia
Phone 74767 0
+612 40420000
Fax 74767 0
Email 74767 0
Heidi.Janssen@newcastle.edu.au
Contact person for scientific queries
Name 74768 0
Dr Heidi Janssen
Address 74768 0
Hunter Medical Research Institute
Kookaburra Circuit
New Lambton Heights
New South Wales
2305
Country 74768 0
Australia
Phone 74768 0
+612 40420000
Fax 74768 0
Email 74768 0
Heidi.Janssen@hnehealth.nsw.gov.au

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What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23524Ethical approval    372927-(Uploaded-16-03-2021-11-05-29)-Study-related document.pdf

Results publications and other study-related documents

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