Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000284662
Ethics application status
Approved
Date submitted
13/04/2011
Date registered
18/03/2014
Date last updated
18/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Central Australian Heart Protection Study: A Randomised Trial of Nurse-Led, Family Based Secondary Prevention of Acute Coronary Syndromes.
Scientific title
The Central Australian Heart Protection Study: A Randomised Trial of Nurse-Led, Family Based Secondary Prevention of Acute Coronary Syndromes.
Secondary ID [1] 259994 0
Nil
Universal Trial Number (UTN)
U1111-1120-7348
Trial acronym
CAHPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndromes 265645 0
Condition category
Condition code
Cardiovascular 265775 265775 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to test the effectiveness of a culturally appropriate, integrated family based secondary prevention (SP) program in reducing the incidence of major adverse coronary events (MACE) in indigenous and non-indigenous patient’s discharged from Alice Springs Hospital following an Acute Coronary Syndrome ACS.

Key features of the study intervention will include:

1. A 90minute comprehensive, home-based assessment of factors likely to positively or negatively impact on the longer-term CV health of the patient within 14 days of hospital discharge. This assessment will occur at baseline, and protocol driven management and education will be delivered by individual case-managers focused on medical therapy, cardiac education and awareness, symptom recognition, necessary follow up and guideline based stepped care to target.

2. A computerised decision support system incorporating all clinical and demographic data relative to local evidence-based guidelines (CARPA Standard Treatment Manual) will be used to guide individual case management, delivered by outreach nurses at baseline, 6 months, 12 months with final close out visit at 24 months. Visits last for approximately 1 hour. Individual follow up may vary according to predefined risk, clinical stability and the achievement of secondary prevention targets in blood pressure, lipid levels and psychosocial status (depression scores). Those individuals at elevated risk or clinically unstable will be visited at weekly to three monthly intervals (in addition to standard visit follow up) until clinically stable.

3. Repeated application of the decision support tool over twelve months of active nurse-led stepped care, to identify key therapeutic targets and treatments necessary to achieve them for optimal risk reduction (secondary prevention) in patients with ACS.

4. A family-based clinical and education intervention will also applied by a trained cardiac nurse and Aboriginal Health Worker (AHW) tailored to the patient’s health assessment (as specified above). This will occur once at the first home visit, and last approximately 30-60 minutes.
Intervention code [1] 264409 0
Prevention
Intervention code [2] 288501 0
Rehabilitation
Intervention code [3] 288502 0
Lifestyle
Comparator / control treatment
Usual Care will consist of standard care as provided by the patients general practitioner/Primary care providers. All such therapy is outlined in the CARPA standard treatment manual for secondary prevention of Coronary heart disease.
Control group
Active

Outcomes
Primary outcome [1] 266529 0
Major Adverse Cardiovascular Endpoint (MACE) - death, non-fatal ACS, stroke, or unplanned revascularisation. Hospitalisation (hospital separation ICD-10) and vital statistics data (NDI propensity matched mortality data) will be collated on each individual at study close out, and according to standardised hospitalisation and event forms to be completed prospectively by individual case managers. Each event will have details collated and will be reviewed by a blinded outcome adjudication committee according to standardised outcome definitions.
Timepoint [1] 266529 0
2 years
Secondary outcome [1] 273980 0
Receipt of evidence based care (recorded from patient interview and medical records and collated on case report forms).

Timepoint [1] 273980 0
24 months
Secondary outcome [2] 273981 0
CVD-related and all-cause hospital admissions will be recorded from review of NT hospitalisations database/clinical records within local hospital. Interstate hospitalisations will be identified through patient interview and primary care record review at close out. ICD-10 primary and secondary hospitalisation codes will be reviewed, medical records reviewed and blinded end-point committee will determine CVD/non-CVD related events.
Timepoint [2] 273981 0
24 months
Secondary outcome [3] 273982 0
Proportion of family buddies with CV risk factors (hypertension, dyslipidaemia, abdominal obesity, elevated BMI and smoking). Individual buddies will have explicit Case report forms for collation of individual risk at baseline and close-out. Close visits will involve direct clinical assessment and review of behavioural factors by clinical staff.
Timepoint [3] 273982 0
24 months
Secondary outcome [4] 306133 0
Achievement of clinical targets (BP, lipid fractions (TC, HDL-C, LDL-C, and triglycerides), and glycosylated haemoglobin (HbA1c), Each individual will have a close-out assessment at 2 years to determine their cardiovascular risk status (in the same manner as at baseline). Proportions of individual achieving evidence based practice guideline (NHF, CARPA STM, NHMRC, KHA) directed targets for lipid sub-fractions and HBA1c will be determined
Timepoint [4] 306133 0
24 months
Secondary outcome [5] 306134 0
Anthropometric measures (weight, waist and hip circumference);
Timepoint [5] 306134 0
24 months
Secondary outcome [6] 306135 0
Psychosocial status (depression score).
Timepoint [6] 306135 0
24 months

Eligibility
Key inclusion criteria
All patients admitted to the Alice Springs Hospital with the admission diagnosis of ST elevation myocardial infarction (STEMI), Non ST segment elevation ACS, or angina.

Aged over 18 years

Able to provide informed consent

Resident of Central Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they do not survive to discharge, have a discharge diagnosis inconsistent with ACS, who are not residents of Central Australia (i.e. Interstate or international visitors), or who have a significant neurological/cognitive impairment that prevents informed consent being obtained

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Stratified randomisation (based on Indigenous versus non-Indigenous status and on a 1:1 intervention to control basis) will occur following consent and via a blinded protocol at the time of discharge from hospital. To reduce contamination, we will ensure that individuals from the same household (in the event that two eligible patients are recruited from the same family) will be randomised to the same arm of the trial. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generated randominsation
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
1/12/2011
Date of last participant enrolment
Anticipated
29/11/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 1879 0
Alice Springs Hospital - Alice Springs
Recruitment postcode(s) [1] 7657 0
0870 - Alice Springs

Funding & Sponsors
Funding source category [1] 264881 0
Government body
Name [1] 264881 0
NHMRC
Country [1] 264881 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Baker IDI Heart and Diabetes Institute
Address
Central Australia
W&E Rubuntja Building
Alice Springs Hospital
Gap Rd, Alice Springs 0870, NT
Country
Australia
Secondary sponsor category [1] 287175 0
None
Name [1] 287175 0
Address [1] 287175 0
Country [1] 287175 0
Other collaborator category [1] 251950 0
University
Name [1] 251950 0
Melinda Carrington
Address [1] 251950 0
Baker IDI
75 Commercial Road
Melbourne VIC, 3004
Country [1] 251950 0
Australia
Other collaborator category [2] 251951 0
University
Name [2] 251951 0
Sandra Eades
Address [2] 251951 0
Baker IDI
75 Commercial Road
Melbourne VIC, 3004
Country [2] 251951 0
Australia
Other collaborator category [3] 251952 0
University
Name [3] 251952 0
David Thompson
Address [3] 251952 0
Australian Catholic University
Locked Bag 4115
Fitzroy MDC
Fitzroy Victoria 3065
Country [3] 251952 0
Australia
Other collaborator category [4] 251953 0
University
Name [4] 251953 0
Christopher Zeitz
Address [4] 251953 0
Adelaide University
C/O Queen Elizabeth Hospital
28 Woodville Road
Woodville West SA 5011
Country [4] 251953 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266835 0
Central Australian Human Research Ethics Committee
Ethics committee address [1] 266835 0
C/- Centre for Remote Health
PO Box 4066, Alice Springs, NT 0871
Ethics committee country [1] 266835 0
Australia
Date submitted for ethics approval [1] 266835 0
10/05/2011
Approval date [1] 266835 0
Ethics approval number [1] 266835 0

Summary
Brief summary
Despite the high burden of cardiovascular diseases among Indigenous Australians, few intervention trials have sought to evaluate novel approaches to reducing differential outcomes in this vulnerable group. The Central Australian Heart Protection Study seeks to test the effectiveness of a nurse-led, family based education and assessment program in reducing the incidence of poor outcomes in indigenous and non-indigenous patient’s following an Acute Coronary Syndrome (ACS).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32484 0
Prof Alex Brown
Address 32484 0
Level 9, 121 King William Street Adelaide, SA 5001
Country 32484 0
Australia
Phone 32484 0
+61 8 81164427
Fax 32484 0
Email 32484 0
alex.brown@sahmri.com
Contact person for public queries
Name 15731 0
Alex Brown
Address 15731 0
Baker IDI Central Australia
W&E Rubuntja Building
Alice Springs Hospital
Gap Road
Alice Springs, NT 0870
Country 15731 0
Australia
Phone 15731 0
+61 8 8959 0111
Fax 15731 0
+61 8 8952 1557
Email 15731 0
alex.brown@bakeridi.edu.au
Contact person for scientific queries
Name 6659 0
Alex Brown
Address 6659 0
Baker IDI Central Australia
W&E Rubuntja Building
Alice Springs Hospital
Gap Road
Alice Springs, NT 0870
Country 6659 0
Australia
Phone 6659 0
+61 8 8959 0111
Fax 6659 0
+61 8 8952 1557
Email 6659 0
alex.brown@bakeridi.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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