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Trial registered on ANZCTR


Registration number
ACTRN12616000282482
Ethics application status
Approved
Date submitted
18/02/2016
Date registered
3/03/2016
Date last updated
22/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of healthy lifestyle changes on stroke risk in adults with cardiovascular disease
Scientific title
The effect of healthy lifestyle changes on stroke risk in adults with cardiovascular disease
Secondary ID [1] 288570 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk factors for stroke 297693 0
Stroke prevention 297697 0
Condition category
Condition code
Stroke 297877 297877 0 0
Haemorrhagic
Stroke 297910 297910 0 0
Ischaemic
Cardiovascular 297911 297911 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants: In this feasibility study we aim to recruit 50 participants via existing networks in GP practices, such as those newly dispensed a medication for cardiovascular disease or those at >15% risk according to the www.cvdcheck.org.au calculator. We intend to liaise closely with the GPs and onsite Pharmacist to access this information.

Life's Simple 7 Intervention: there will be five key aspects to the 6 month service:
1. Education Package and session specific to cardiovascular disease: This will involve a once off, face-to-face, 2 hour, small group education session, utilising a Chronic Condition Self-Management approach. This will be conducted by a physiotherapist trained in chronic condition self-management. As part of this session, participants will also be provided with a comprehensive educational package based on the American Heart Foundation's program - Life's Simple 7. Given the groups will have about 6-8 participants per group, it is envisaged 6-9 groups will be conducted.

2. Motivational interview with identification of 'nudging' strategies to promote and support identified behaviour change: After the group session a time will be booked to visit each participant and undertake a face-to-face 'assessment', utilising a motivational interview approach. This assessment will be undertaken by the same physiotherapist who conducted the group session and is estimated to take about 1.5 hours. This session will gather data on baseline measures, areas for change, set goals and develop a plan to achieve the participants desired goals. Part of this plan will involve 'nudging' strategies to help each participant achieve their desired goals through long term behaviour change.

3. Individual sessions ( physiotherapist and GP consultations): Through the 6 month intervention, individual sessions will be scheduled for each participant. These sessions will involve a combination of phone and in person sessions, based on the aim of the session and participant preferences. The aim will be to track goals, assist in further motivation/accountability and identify other input that may be required along the way (e.g. dietician, GP review, pharmacist). The number of individual sessions will be based on each person's unique needs.

4. Longer term monitoring with ongoing new 'nudges', liaison and Health Diary: A health dairy will be provided to each participant at commencement of this study. This diary contains vital health information (cardiovascular risk factors) and self-monitoring (nutrition, activity levels, weight, BP, cholesterol, smoking). Participants complete the diary daily and provide feedback about their progress and goals. They will be provided with emails, messages, phone-calls to further support them in this, as well as ongoing 'nudges' to help them achieve their goals. These will be provided dependent on each participants unique needs and what they are trying to achieve at that stage.

5. Health Buddy: At the beginning of the project, each participant will select a health buddy. This will be a person they know (e.g. friend, neighbour) that can support them and encourage them along their journey to be a healthy version of themselves. The health buddy will attend the initial group session, as well as all the face-to-face sessions throughout the 6 months.
Intervention code [1] 293956 0
Lifestyle
Intervention code [2] 293957 0
Prevention
Intervention code [3] 293982 0
Behaviour
Comparator / control treatment
Feasibility study: no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297401 0
Physical activity - short version IPAQ
Timepoint [1] 297401 0
baseline and 6 months
Primary outcome [2] 297430 0
Fasting Cholesterol assessed by serum assay - completed by patient's GP
Timepoint [2] 297430 0
baseline and 6 months
Primary outcome [3] 297431 0
Nutrition - assessed using Life's Simple 7 Nutrition Score- American Heart Foundation
Timepoint [3] 297431 0
baseline and 6 months
Secondary outcome [1] 320966 0
Resting blood pressure assessed using automatic sphygmomanometer- completed by patient's GP
Timepoint [1] 320966 0
Baseline and 6 months
Secondary outcome [2] 321026 0
Weight - assessed using calibrated digital scales
Timepoint [2] 321026 0
baseline and 6 months
Secondary outcome [3] 321027 0
Fasting blood glucose levels - Glucose concentration determined in whole blood sample
Timepoint [3] 321027 0
baseline and 6 months
Secondary outcome [4] 321028 0
Smoking status - Self-reported based on questions designed for this study - non-smoker or smoker,
If smoker measured in packs/day.
If non-smoker currently, but was a smoker - length of time since quitting will be collected as well as packs/day history prior to cessation of smoking.
Timepoint [4] 321028 0
baseline and 6 months

Eligibility
Key inclusion criteria
Number of groups: 1 (n = 50)
Age range: adults above 18, no upper age limit
Characteristics: those who have been identified by their usual GP as having cardiovascular disease risk factors. Factors taken into account include: those with hypertension, hypercholesterolaemia, taking medications for either of these conditions, and >15% risk of cardiovascular disease according to the www.cvdcheck.org.au calculator
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adults with known cognitive impairment, inability to provide informed consent. Note we will accept adults with limited English proficiency and provide qualified interpreters for the education and motivational interviewing sessions. Medically unstable

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/03/2016
Actual
1/07/2016
Date of last participant enrolment
Anticipated
22/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 292917 0
Charities/Societies/Foundations
Name [1] 292917 0
The Nancy and Vic Allen Stroke Prevention fund
Country [1] 292917 0
Australia
Primary sponsor type
University
Name
The Univeristy of South Australia
Address
The University of South Australia
School of Health Sciences
City East Campus
Corner of North Terrace and Frome Road
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 291672 0
None
Name [1] 291672 0
Address [1] 291672 0
Country [1] 291672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294423 0
The University of South Austalia's Human Research Ethics Committee
Ethics committee address [1] 294423 0
University of South Australia
City East Campus
Corner of North Terrace and Frome Road
Adelaide SA 5000
Ethics committee country [1] 294423 0
Australia
Date submitted for ethics approval [1] 294423 0
28/08/2015
Approval date [1] 294423 0
15/10/2015
Ethics approval number [1] 294423 0
0000034694

Summary
Brief summary
Our aims of the study are:
1. Increase awareness and adoption of healthy lifestyle factors for people with cardiovascular risk factors, to prevent cardiovascular morbidity and mortality
2. To conduct a feasibility study in the primary care setting to promote the Life's Simple 7 approach, developed by the American Heart Association, for people at risk of stroke
3. To implement a 6 month study to confirm the feasibility, and to provide preliminary data on effectiveness of such an approach.

1. Our overarching hypothesis is that targeted and individualised, longterm support will result in significantly reduced rate of, and risk factors for, morbidity and mortality from stroke and other causes, compared to current practice
2. The 6 month intervention, based on the Life's Simple 7 (LSS) approach, will result in a reduction in stroke risk, measured using the LSS score
3. We hypothesise that the intervention will be feasible, acceptable for participants and we will also collect cost data to determine if the approach is cost effective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63654 0
Dr Michelle McDonnell
Address 63654 0
University of South Australia
School of Health Sciences
Internal Post Code CEA-14
GPO Box 2471
Adelaide SA 5001
Australia
Country 63654 0
Australia
Phone 63654 0
+61 8 8302 1684
Fax 63654 0
Email 63654 0
[email protected]
Contact person for public queries
Name 63655 0
Michelle McDonnell
Address 63655 0
University of South Australia
School of Health Sciences
Internal Post Code CEA-14
GPO Box 2471
Adelaide SA 5001
Australia
Country 63655 0
Australia
Phone 63655 0
+61 8 8302 1684
Fax 63655 0
Email 63655 0
[email protected]
Contact person for scientific queries
Name 63656 0
Michelle McDonnell
Address 63656 0
University of South Australia
School of Health Sciences
Internal Post Code CEA-14
GPO Box 2471
Adelaide SA 5001
Australia
Country 63656 0
Australia
Phone 63656 0
+61 8 8302 1684
Fax 63656 0
Email 63656 0
[email protected]

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No Supporting Document Provided



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