Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001022853
Ethics application status
Approved
Date submitted
31/05/2021
Date registered
5/08/2021
Date last updated
19/09/2024
Date data sharing statement initially provided
5/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Kaat Koort: Examining the impact of a program targeting cardio-metabolic risk and lifestyle changes on heart and brain health among Aboriginal and Torres Strait Islander people
Scientific title
Kaat Koort: Examining the impact and efficacy of an Aboriginal health practitioner-led program targeting cardio-metabolic risk and lifestyle changes on blood pressure, cardio-metabolic health and cognitive functioning among Aboriginal and Torres Strait Islander adults aged 35-60 years : A pragmatic randomised controlled trial
Secondary ID [1] 304231 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 322095 0
hypertension 322096 0
cardiovascular disease 322097 0
cognitive decline 322098 0
Condition category
Condition code
Cardiovascular 319811 319811 0 0
Hypertension
Cardiovascular 319812 319812 0 0
Coronary heart disease
Neurological 319813 319813 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A one-year intervention program will be guided and led by Aboriginal health practitioners (AHPs) and will involve a cardiovascular risk management program, lifestyle program targeting diet and physical activity, targeted advice and coaching for smoking cessation (for current smokers) and depression (for those at high risk of depression). All intervention protocols will be developed in consultation with AHPs and relevant staff from the Aboriginal community-controlled health services. The study will be conducted in two sites in Western Australia (Derbarl Yerrigan Health Service in Perth and South West Aboriginal Medical Service in Bunbury). Please see details of the intervention components below:
1) Cardio-metabolic risk management program: Once the participant’s cardio-metabolic risk factors have been identified, an appointment with the general practitioner (GP) at the health service will be made to form a cardiovascular risk management plan. Pharmacological treatment may be included as part of the care plan if recommended by the GP but it is not a specific component of the intervention. The Aboriginal health practitioner will then meet with the participant to go through the care plan and ensure they have understood the care plan and to answer any questions. There are 15 cardiometabolic risk management visits over 12 months (4 visits in the first 6 weeks then monthly visits). These visits will vary in duration from 30 minutes to 1 hour.
2) Lifestyle Program: Consists of individual and group sessions focused on diet and physical activity.
Individual diet sessions: All participant will have an individual appointment with the dietitian during Week 1 to assess their current diet. A tailored diet plan will be created for the participant, based on areas that they are willing to address and per their cardio-metabolic risk factors (e.g. diabetes, high blood pressure). The participant will meet again with the dietitian in Week 2 to assess the diet plan. Starting from month 2 onwards, the individual diet sessions will occur monthly. All individual diet sessions will be 1 hour in duration. Dietary plans will be made in accordance with the Australian dietary guidelines. Adherence to the sessions will be monitored by recording attendance at each session and reasons for not attending.
Group diet and physical activity sessions: The first group session focusing on diet and physical activity will start in Month 2 and will occur monthly then after. Groups of 10 participants will meet face-to-face at a suitable venue with a dietitian, exercise therapist and an AHP. The session is expected to last for approximately 2 hours and will cover specific diet topics with infographics that have been specifically designed for this project. The educational topics include: Wholegrains, Dairy, Fast food, Fruits, Vegetables, Healthy fats, Lean meat, Processed/salty foods and Sugar. The group session will also include a physical activity component (approximately 1 hour) where an exercise therapist and AHP will lead a guided physical activity session focusing on aerobic and strength building exercises. Adherence to the sessions will be monitored by recording attendance at each session and reasons for not attending.
Group physical activity sessions: In addition to the monthly group diet and physical activity sessions, there will also be monthly sessions focused on physical activity. Groups of 10 participants (preferably the same 10 participants that were in the group diet/physical activity session) will meet face-to-face at a suitable venue with an exercise therapist and AHP who will lead the physical activity session focusing on aerobic and strength building exercises. The exercises will be tailored to the group’s age and abilities and is expected to range from low to vigorous intensity. The session will last for approximately 1 hour. Physical activity recommendations will be made according to the Australian physical activity guidelines. Adherence to the sessions will monitored by recording attendance at each session and reasons for not attending. Participants will also receive a physical activity manual consisting of exercises that can be done at home, which has been specifically developed for this study. The types of exercises included in the group activity will be guided by the exercise therapist and will consist of a range of indoor and outdoor activities, at low, moderate and high intensities. Examples of aerobic (cardio) exercises include: walking, star jumps, group aerobics, dancing, swimming. Examples of strength building exercises include: sit to stand; squats; arm raises; arm curls, air punches, chair dips, sit ups.
Intervention code [1] 320689 0
Prevention
Intervention code [2] 320690 0
Lifestyle
Intervention code [3] 320691 0
Behaviour
Comparator / control treatment
Participants randomised to the usual care group will receive their usual care at the health service. These participants will receive three individual dietary counselling sessions but no guided group diet sessions. A dietary counselling session with the study dietitian will occur during the first month of the study (the session will last for approximately 1 hour). The session will consist of the dietitian creating an individual dietary plan for the participant based on their current diet and any changes recommended based on risk factors. Based on the participant’s responses to the physical activity questionnaire, recommendations on physical activity will be made by the Aboriginal health practitioner using the Australian physical activity guidelines. Participants will also receive the physical activity manual consisting of exercises that can be done at home, which has been specifically developed for this study by an exercise physiologist.
Participants with a PHQ-9 score of 10 or greater (indicating high risk of major depression) and who indicate they are current regular smokers, will follow the existing usual care pathway of the health service—accordingly, AHPs will refer them to a clinic General Practitioner for the purposes of (1) further treatment for potential mental health issues and (2) to support the participant to quit smoking. Patients attending the Aboriginal medical service (AMS) who are looking to quit smoking are encouraged to talk to a GP for support and advice. In addition, AMS will advertise the available national hotlines and organisations for additional support and information. They note that Quitline employs Aboriginal counsellors with comprehensive training to assist people with smoking cessation in a culturally appropriate way.
Control group
Active

Outcomes
Primary outcome [1] 327677 0
Systolic blood pressure assessed using an automatic blood pressure machine.
Timepoint [1] 327677 0
Baseline, 6 months and 12 months (primary endpoint)
Primary outcome [2] 328256 0
Diastolic blood pressure assessed using an automatic blood pressure machine.
Timepoint [2] 328256 0
Baseline, 6 months and 12 months (primary endpoint)
Secondary outcome [1] 396205 0
Absolute cardiovascular risk score calculated using: age, gender, systolic blood pressure, smoking status, total cholesterol, HDL-cholesterol and diabetes
Timepoint [1] 396205 0
Baseline, 6 months and 12 months
Secondary outcome [2] 396206 0
Cognitive function assessed using CogState Brief Battery
Timepoint [2] 396206 0
Baseline and 12 months
Secondary outcome [3] 396207 0
Cognitive function assessed using the Symbol Digit Modalities Test (SDMT)
Timepoint [3] 396207 0
Baseline and 12 months
Secondary outcome [4] 397919 0
Meeting the recommended Australian dietary guidelines
Timepoint [4] 397919 0
Baseline, 6 months and 12 months
Secondary outcome [5] 397920 0
Meeting the recommended Australian physical activity guidelines
Timepoint [5] 397920 0
Baseline, 6 months and 12 months
Secondary outcome [6] 397921 0
Waist circumference using a tape measure
Timepoint [6] 397921 0
Baseline, 6 months and 12 months
Secondary outcome [7] 397922 0
HbA1c assessed through a blood test
Timepoint [7] 397922 0
Baseline, 6 months and 12 months
Secondary outcome [8] 397923 0
High density lipoprotein cholesterol assessed through a blood test
Timepoint [8] 397923 0
Baseline, 6 months and 12 months
Secondary outcome [9] 439846 0
Elevated blood pressure (assessed using an automatic blood pressure machine): Either systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg.
Timepoint [9] 439846 0
Secondary outcome [10] 439847 0
Elevated blood pressure (assessed using an automatic blood pressure machine): Either systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg.
Timepoint [10] 439847 0
Baseline, 6 months and 12 months

Eligibility
Key inclusion criteria
Participants will include Aboriginal and Torres Strait Islander people aged 35 to 60 years of age from Perth and Bunbury in Western Australia at high risk of cardiovascular disease. Participants will be classified as ‘high risk’ if they: have a previous history of atherosclerotic cardiovascular disease (e.g. stroke, coronary artery disease, peripheral vascular disease, heart failure) or are current regular smoker or have any two of the following risk factors diagnosed within the past 3 months: elevated blood pressure, elevated waist circumference, reduced high density lipoprotein (HDL) C, elevated low density lipoprotein (LDL) C or elevated HbA1C.
Minimum age
35 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior diagnosis of dementia and/or cognitive impairment
- Clinically assessed as not being able to participate in the proposed intervention
- Currently pregnant or planning a pregnancy
- Enrolled in another clinical trial

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 concealment will occur through central randomisation by computer program (REDCap). The randomisation list will be computer-generated by an independent statistician and carried out centrally to ensure concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block permuted randomisation will be used with the study site (Perth and Bunbury) and age groups (35-44 years, 45-60 years) as stratification factors to ensure balance in treatment allocation within each centre.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The original sample size calculation at trial commencement was based on a binary primary outcome. A total sample size of 300 (150 intervention subjects and 150 control subjects) will provide 80% power to detect a minimum clinically important difference of 4mmHg in mean change in diastolic blood pressure at 12 months follow-up between the intervention and control arm with two-sided a=0.05 divided between the two primary outcomes. This assumes equal standard deviations of 11mmHg in both groups based on estimates from Carrington et al. (2021) and no correlation between baseline and follow-up diastolic blood pressure (conservative assumption). Accounting for potential loss-to-follow up of 15%, overall the trial would require 177 participants randomized in each group (total sample size 354 participants). This sample size provides >95% power to detect a minimum clinically important difference of 8mmHg in the other primary outcome, systolic blood pressure, between the two study arms, assuming a standard deviation of 15mmHg.

Constrained longitudinal data analysis (cLDA) models will be used to examine the change in each of the primary outcomes (systolic and diastolic blood pressure), with the response consisting of all scores (baseline, 6 months and 12 months) and the model including factors representing group (intervention/control), time, intervention by time interaction and the strata (site and age group), with the restriction of a common baseline mean across interventions. This is based on the assumption that at baseline there are no differences in the mean secondary outcomes between the treatment groups; namely, that the randomisation was effective. The mean change in each of systolic and diastolic blood pressure from baseline to each follow-up time point between the two treatment arms will be obtained. The primary research question will be evaluated by obtaining the estimated differences between the two treatment arms in mean change in systolic and diastolic blood pressure from baseline to 12 months follow-up (primary time point), two-sided 97.5% confidence intervals and p-values. A similar approach will be used for continuous secondary outcomes. For binary outcomes, logistic regression models controlling for stratification factors will be fitted using generalised estimating equations to account for clustering of time within participants, with risk differences and 95% confidence intervals calculated.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
16/08/2021
Actual
1/09/2021
Date of last participant enrolment
Anticipated
30/12/2022
Actual
20/07/2023
Date of last data collection
Anticipated
31/12/2024
Actual
30/08/2024
Sample size
Target
392
Accrual to date
Final
232
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 308609 0
Government body
Name [1] 308609 0
National Health and Medical Research Council of Australia
Country [1] 308609 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
207 Bouverie Street
University of Melbourne
Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 309600 0
None
Name [1] 309600 0
Address [1] 309600 0
Country [1] 309600 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308541 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [1] 308541 0
Ethics committee country [1] 308541 0
Australia
Date submitted for ethics approval [1] 308541 0
Approval date [1] 308541 0
07/08/2020
Ethics approval number [1] 308541 0
HREC 947
Ethics committee name [2] 308635 0
University of Melbourne Medicine and Dentistry Human Ethics Subcommittee
Ethics committee address [2] 308635 0
Ethics committee country [2] 308635 0
Australia
Date submitted for ethics approval [2] 308635 0
Approval date [2] 308635 0
16/10/2020
Ethics approval number [2] 308635 0
2056720

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

Contacts
Principal investigator
Name 111070 0
Prof Sandra Eades
Address 111070 0
207 Bouverie Street, University of Melbourne, Carlton, VIctoria 3010
Country 111070 0
Australia
Phone 111070 0
+61 3 90357863
Fax 111070 0
Email 111070 0
[email protected]
Contact person for public queries
Name 111071 0
Carrington Shepherd
Address 111071 0
Building 410, Curtin Medical School, Curtin University, Perth WA 6102
Country 111071 0
Australia
Phone 111071 0
+61892662043
Fax 111071 0
Email 111071 0
[email protected]
Contact person for scientific queries
Name 111072 0
Carrington Shepherd
Address 111072 0
Building 410, Curtin Medical School, Curtin University, Perth WA 6102
Country 111072 0
Australia
Phone 111072 0
+61892662043
Fax 111072 0
Email 111072 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11782Study protocol    382003-(Uploaded-19-06-2024-13-58-27)-Kaat Koort - Study Protocol_April 2024_Version 7_CLEAN.pdf
11783Ethical approval    382003-(Uploaded-27-05-2021-17-09-30)-Study-related document.pdf



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.