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Trial registered on ANZCTR


Registration number
ACTRN12618000581268
Ethics application status
Approved
Date submitted
29/03/2018
Date registered
16/04/2018
Date last updated
27/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Yeddung Gauar (Good Heart): Feasibility of an Aboriginal and Torres Strait Islander female Cardiac Rehabilitation program delivered in a non-Indigenous health service.
Scientific title
Yeddung Gauar (Good Heart): Feasibility of an Aboriginal and Torres Strait Islander female Cardiac Rehabilitation program delivered in a non-Indigenous health service.
Secondary ID [1] 294453 0
None
Universal Trial Number (UTN)
U1111-1211-3775
Trial acronym
GoodHeart-CR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic Heart Disease 307202 0
Heart Attack 307203 0
Medium-high risk of a cardiac event 307237 0
Condition category
Condition code
Cardiovascular 306313 306313 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 306497 306497 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An 18-week mixed methods feasibility study will be conducted, with weekly CR sessions consisting of 1 hour of exercise and 30 minutes of education delivered by a multidisciplinary team, including an Indigenous Health Worker. Participants will be recruited from a variety of settings, with the aim to recruit a minimum of 20 participants.

Attendance will be flexible, aiming for participants to complete 6 sessions and attendance checklists will be completed for every session. Participants will be re-assessed after every sixth session attended and can continue attending the program following this, if desired. The Aboriginal Community Bus will be utilised to bring participants to and from the University of Canberra’s Faculty of Health Clinics. This will be coordinated by the projects Research Assistant and the IHW.

The main aim of the exercise sessions will be to increase cardiovascular fitness by exercising large muscle groups. Sessions will be run as a group circuit class, supervised by a physiotherapist and/or exercise physiologist and will be individually tailored for each of the participants based on pre assessments. The exercise sessions will include a 10 minute warm up and cool down and 40 minutes of aerobic exercise including upper limb resistance excises, lower limb strengthening, overground/treadmill walking and stationary cycling. Intensity of the exercise will be assessed via the Borg RPE Scale.

Members of the multi-disciplinary team will conduct educational lectures to increase participant knowledge of their CVD condition and increase self-management skills for risk factor management. The education sessions/lectures will cover; cardiac anatomy and physiology; cardiac risk factors, modification and management of symptoms; how to deal with stress, anxiety and depression; cardiac medications; benefits of exercise and physical activity; and nutrition advice. This information will be delivered in a flexible, nonthreatening manner using Indigenous resources from the National Heart Foundation.
Intervention code [1] 300741 0
Lifestyle
Intervention code [2] 300744 0
Treatment: Other
Intervention code [3] 300745 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305326 0
Feasibility measure: Data will be collected on participant recruitment rates.
Timepoint [1] 305326 0
At 18 weeks (post program).
Primary outcome [2] 305400 0
Feasibility measure: Data will be collected on participant adherence to the program (number of exercise and education sessions attended) and on the number of drop-outs.
Timepoint [2] 305400 0
At 18 weeks (post program).
Primary outcome [3] 305402 0
Composite Primary Outcome of Health workforce cultural safety and cultural awareness and sensitivity of Health Professionals in working with Aboriginal and Torres Strait Islander populations via a de-identified questionnaire (designed specifically for this study), a focus group and survey assessing perceptions of cultural safety.
Timepoint [3] 305402 0
Baseline and 18 weeks (pre and post program).
Secondary outcome [1] 344845 0
Body Mass Index (BMI). BMI (kg/m2) with be recorded using calibrated set of scales and a stadiometer.
Timepoint [1] 344845 0
Baseline and every sixth session attended by participants.
Secondary outcome [2] 344846 0
Waist-to-hip ratio (WHR). Waist circumference and hip circumferences will be measured in centimetres using a tape measure.
Timepoint [2] 344846 0
Baseline and every sixth session attended by participants.
Secondary outcome [3] 344847 0
Blood pressure. Blood pressure levels will be obtained using mercury sphygmomanometer on the right arm of seated subjects.
Timepoint [3] 344847 0
Baseline and every sixth session attended by participants.
Secondary outcome [4] 344848 0
Random point-of-care glucose levels are taken from a fingerstick blood sample applied to a strip, that is inserted into a reader, and results are available in 2 minutes.
Timepoint [4] 344848 0
Baseline and every sixth session attended by participants.
Secondary outcome [5] 344849 0
Sub-maximal exercise capacity assessed using the 6-minute walk test (6MWT).
Timepoint [5] 344849 0
Baseline and every sixth session attended by participants.
Secondary outcome [6] 344850 0
Health-related quality of life. The Macnew questionnaire will used for the assessment of heart disease specific health-related quality of life.
Timepoint [6] 344850 0
Baseline and every sixth session attended by participants.
Secondary outcome [7] 344851 0
Anxiety. The Hospital Anxiety and Depression Scale questionnaire will be used for the assessment of anxiety.
Timepoint [7] 344851 0
Baseline and every sixth session attended by participants.
Secondary outcome [8] 344852 0
Composite Secondary Outcome: Participant Evaluation and satisfaction of program: On completion of the program (>1 sessions attended) all participants will be assessed and inviteded to submit an evaluation form (specially designed for this program) which will include questions on motivation to take part and continue with the program, program content and satisfaction. Additionally, unstructured interviews and a focus group will be conducted with willing participants to investigate these issues.
Timepoint [8] 344852 0
At 18 weeks (post program).

Eligibility
Key inclusion criteria
Female Indigenous adults (greater than or equal to 18 years old) will be eligible for inclusion in the Good Heart program at the University of Canberra’s Faculty of Health Clinics. Participants will be included if they have stable heart disease and are receiving optimal medical treatment +/- revascularisation (CABG, PCI), or have had a heart attack. Additionally, participants will be included if they are at medium-to-high risk of developing heart disease. The Absolute Risk (AR) Calculator will be used to determine their level of CVD risk in the next 5 years.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they have New York Heart Association class II-IV symptoms of heart failure (or documented signs and symptoms of chronic heart failure), with ejection fraction <45%), uncontrolled arrhythmias, severe chronic obstructive pulmonary disease, uncontrolled hypertension, symptomatic peripheral artery disease, unstable angina, uncontrolled diabetes, are unable to perform a sub maximal walking test (6-minute walk test), or are unable to wear an accelerometer due to disability, for example, if they are confined to a wheelchair.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No control group - Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
All participants who completed the baseline assessment and attended at least one session within the feasibility study at the University of Canberra’s Faculty of Health Clinics will be included in the evaluation sample. Quantitative analysis of baseline and outcome measures will be conducted. A p-value of less than 0.05 will be considered statistically significant. A qualitative thematic analysis of feedback (interview, focus group, survey) from both participants and staff will also be undertaken.

Recruitment
Recruitment status
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)
ACT,NSW
Recruitment hospital [1] 10484 0
The Canberra Hospital - Garran
Recruitment hospital [2] 10485 0
Calvary Public Hospital ACT - Bruce
Recruitment postcode(s) [1] 22197 0
2605 - Garran
Recruitment postcode(s) [2] 22198 0
2617 - Bruce
Recruitment postcode(s) [3] 22199 0
2620 - Queanbeyan
Recruitment postcode(s) [4] 22200 0
2582 - Yass

Funding & Sponsors
Funding source category [1] 299061 0
University
Name [1] 299061 0
The University of Canberra
Address [1] 299061 0
University Drive, Bruce, ACT, 2617
Country [1] 299061 0
Australia
Primary sponsor type
Individual
Name
Dr Nicole Freene
Address
University of Canberra, Univeristy Drive, Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 298296 0
Individual
Name [1] 298296 0
Alicia Jackson
Address [1] 298296 0
The University of Canberra, Univeristy Drive, Bruce, ACT, 2617
Country [1] 298296 0
Australia
Secondary sponsor category [2] 298351 0
Individual
Name [2] 298351 0
Paul Collis
Address [2] 298351 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country [2] 298351 0
Australia
Secondary sponsor category [3] 298352 0
Individual
Name [3] 298352 0
Chris Bourke
Address [3] 298352 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country [3] 298352 0
Australia
Secondary sponsor category [4] 298353 0
Individual
Name [4] 298353 0
Holly Northam
Address [4] 298353 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country [4] 298353 0
Australia
Secondary sponsor category [5] 298354 0
Individual
Name [5] 298354 0
Katharine Silk
Address [5] 298354 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country [5] 298354 0
Australia
Secondary sponsor category [6] 298355 0
Individual
Name [6] 298355 0
Rachel Davey
Address [6] 298355 0
University of Canberra, University Drive, Bruce, ACT, 2617
Country [6] 298355 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299995 0
The Human Research Ethics Committee (UC-ICR).
Ethics committee address [1] 299995 0
University of Canberra, University Drive, Bruce, ACT, 2617.
Ethics committee country [1] 299995 0
Australia
Date submitted for ethics approval [1] 299995 0
27/12/2017
Approval date [1] 299995 0
01/02/2018
Ethics approval number [1] 299995 0
20180086

Summary
Brief summary
Cardiovascular disease (CVD) is diagnosed in almost half of Indigenous Australians 55 years and over, and is the largest cause of premature deaths in this population. It is widely recognised that cardiac rehabilitation (CR) decreases mortality, improves risk profiles, decreases hospital admissions, increases medication adherence and improves quality of life in those diagnosed with CVD. The aim of this study is to evaluate the feasibility of a female only Aboriginal and Torres Strait Islander CR program in a non-Indigenous health service setting. It will evaluate both the combination of improving access to a CR service; and improving health workforce cultural safety through implementation of an 18-week program of weekly CR sessions consisting of 1 hour of exercise and 30 minutes of education delivered by a multidisciplinary team, including an Indigenous Health Worker. Data will be collected from participants at baseline, and at every sixth session attended. Assessment of health professionals’ cultural awareness and safety pre and post program will be evaluated via a questionnaire. Feasibility measures will include recruitment of participants, adherence to the CR program, drop-out rates and Qualitative data collection from both participants and health professionals will be analysed at the end of the program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82202 0
Dr Nicole Freene
Address 82202 0
Physiotherapy Department, The University of Canberra, University Drive, Bruce, ACT, 2617.
Country 82202 0
Australia
Phone 82202 0
+61 2 62015550
Fax 82202 0
Email 82202 0
nicole.freene@canberra.edu.au
Contact person for public queries
Name 82203 0
Dr Nicole Freene
Address 82203 0
Physiotherapy Department, The University of Canberra, University Drive, Bruce, ACT, 2617.
Country 82203 0
Australia
Phone 82203 0
+61 2 62015550
Fax 82203 0
Email 82203 0
Nicole.freene@canberra.edu.au
Contact person for scientific queries
Name 82204 0
Dr Nicole Freene
Address 82204 0
Physiotherapy Department, The University of Canberra, University Drive, Bruce, ACT, 2617.
Country 82204 0
Australia
Phone 82204 0
+61 2 62015550
Fax 82204 0
Email 82204 0
Nicole.freene@canberra.edu.au

No data has been provided for results reporting
Summary results
Not applicable