Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001184662
Ethics application status
Approved
Date submitted
2/10/2014
Date registered
11/11/2014
Date last updated
11/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a culturally and linguistically appropriate patient education tool to improve conclusive electrocardiography stress testing results in Aboriginal and non-Aboriginal Australian patients.
Scientific title
In patients having an Exercise Stress Test (EST) does a culturally and linguistically appropriate education tool, in comparison to a placebo Coronary Heart Disease (CHD) education video, reduce inconclusive EST.
Secondary ID [1] 285341 0
'None'
Universal Trial Number (UTN)
U1111-1161-7557
Trial acronym
BEST study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 293066 0
Condition category
Condition code
Cardiovascular 293341 293341 0 0
Coronary heart disease
Public Health 293492 293492 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BEST audio-visual tool in a culturally and linguistically appropriate education video that describes how to successfully complete an EST. The 5 minute language intervention tool will be played to patients by the researcher 10 minutes prior to the patients undergoing the EST in the waiting room. Those allocated to intervention will view the content using a hand held tablet computer (iPad) or a DVD in English or one of several local Aboriginal languages. The preference for language will be determined by subject self-selection.
Intervention code [1] 290257 0
Other interventions
Comparator / control treatment
The control group will be shown a placebo audio visual tool developed by the National Heart Foundation. The educational video is titled: 'Warning Signs of a Heart Attack'. This resource will only be available in English and runs for approximately 10 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 293172 0
This study aims to increase conclusive Exercise Stress Testing results amongst testing subjects at the Alice Springs Hospital.

The criteria for inducible ischaemia is as follows:
-ST segment depression >2 mm (Horizontal or down-sloping) in contiguous leads - with or without symptoms
- deep T inversion - with or without symptoms
- ST segment elevation of 1 mm in chest leads or 2 mm in limb leads – with or without symptoms
- Transient LBBB

Equivocal EST – requiring further evaluation:
- ST depression 1-2 mm (Horizontal or down-sloping) with or without symptoms
- Transient T wave changes
- Abnormal BP response.
- Reproducible symptoms (subjective) with no abnormality on ECG or Haemodynamic response or ECG and Haemodynamic abnormalities not qualifying as Positive EST
- Increasingly frequent premature ventricular complexes (PVC) during exercise - suggestive of ischaemia
- Frequent PVCs in recovery period

Negative EST:
- No or <1mm ST segment depression despite achieving 85% of maximal age-predicted HR
- Up-sloping ST depression only
Timepoint [1] 293172 0
Conclusion of electrocardiographic stress test (30 minutes)
Secondary outcome [1] 310504 0
nil
Timepoint [1] 310504 0
nil

Eligibility
Key inclusion criteria
1. 18 years of age and older

2. patient at the Alice Springs Hospital

3. Aboriginal or non-Aboriginal AUstralian

4. participants need to be undertaking a maximal exercise stress testing at the Alice Springs Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects are less than 18 years of age

2. Clinician assessment deems physically incapable of undergoing an exercise stress test

3. Maximal exercise stress test deemed inappropriate by supervising clinician (e.g. uniterpretable electrocardiogram (ECG) such as a left bundle branch block)

4. Maximal exercise stress test deemed to be conraindicated by supervising clinician (e.g. recent Acute Coronary Syndrome)

5. Patient is unable to provide informed consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once informed consent is obtained eligibility will be reassessed and if the patient is suitable they will be allocated a sequential unique study identification code. Only once this code is allocated will the research open a double sealed envelope which matches this identification code containing the subject allocation to active or control intervention. The order of allocation will be pre-determined using a random list generated by the Stata statistical package ‘runiform’ command.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stata to generate a random balanced allocation will have for approximately every 10 participants will be 5 control and 5 intervention.

set obs 100
egen id =equal to seq(), to()
egen = equal to seq(),
set seed 314159
gen random = uniform()
*at this point find the median point of the random sequence to make sure cut point for allocation means 50 in each group therefore - sum random
gen allocation to 0 if random less than <.459047 * (median value) *
replace allocation = 1 if random >= greater than or equal to.459047 list

1. (0) = 50 control and (1) = 50 intervention.

2. 100 envelopes with sequential numbers 1-100 marked on the outside + unmarked envelopes that fit inside + 50 small cards labeled INTERVENTION and 50 CONTROL that fit inside these smaller unmarked envelopes

3. The list generated will have the allocation of intervention or control (based on 0 or 1) cards into plain envelope and seal AND then insert these into relevant ID marked envelope double sealed envelopes with random participant allocation.
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
This study will comprise a piloting prior to anticipated extension to other sites. Whilst it would require the enrolment of 206 Aboriginal people to detect a reduction in the proportion of inconclusive tests from 50% to 30% (compared with 20% for non-Indigenous Australians) (assumed alpha 0.05, beta 0.2, power 0.8) this study will commence with the aim of enrolling 100 patients undergoing an EST, 50 randomized to the active intervention and 50 to the control intervention, with equal numbers of Aboriginal and non-Indigenous Australian participants. Currently Alice Springs Hospital conducts approximately 270 ESTs per year.
Statistical analysis will be undertaken using Stata 13 (StataCorp, Texas, USA). Analysis of the primary endpoint will be undertaken using the Chi square statistic. Factors associated with a conclusive as compared with inconclusive test will be investigated using standard bivariate techniques and multivariable logistic regression. A p value less than 0.05 will be taken to indicate statistical significance and all tests will be two-sided.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/10/2014
Actual
15/10/2014
Date of last participant enrolment
Anticipated
31/03/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 2982 0
Alice Springs Hospital - Alice Springs
Recruitment postcode(s) [1] 8704 0
0870 - Alice Springs

Funding & Sponsors
Funding source category [1] 289955 0
University
Name [1] 289955 0
James Cook University
Country [1] 289955 0
Australia
Primary sponsor type
Individual
Name
Graeme Maguire
Address
Baker IDI
Alice Springs Hospital
Gap Road
Alice Springs NT 0870
Country
Australia
Secondary sponsor category [1] 288645 0
Individual
Name [1] 288645 0
Wendy Anders
Address [1] 288645 0
Institute of Koorie Education
Deakin University (Geelong Campus)
75 Pigdons Road
Waurn Ponds Vic 3216
Deakin University
Country [1] 288645 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291672 0
Central Australian Human Research Ethics Committee
Ethics committee address [1] 291672 0
Ethics committee country [1] 291672 0
Australia
Date submitted for ethics approval [1] 291672 0
18/07/2014
Approval date [1] 291672 0
06/08/2014
Ethics approval number [1] 291672 0
HREC 14-252

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 197 197 0 0
/AnzctrAttachments/367099-BEST - research proposal.pdf

Contacts
Principal investigator
Name 51454 0
Prof Graeme Maguire
Address 51454 0
Baker IDI, W & E Rubuntja Research and medical education building,
Alice Springs Hospital, Gap road, Alice Springs NT 0870 Australia.
Country 51454 0
Australia
Phone 51454 0
+61 8 89590111
Fax 51454 0
+61 8 89521557
Email 51454 0
[email protected]
Contact person for public queries
Name 51455 0
Ricky Mentha
Address 51455 0
Baker IDI W & E Rubuntja Research and medical education building,
Alice Springs Hospital, Gap road, Alice Springs NT 0870 Australia.
Country 51455 0
Australia
Phone 51455 0
+61 8 89590111
Fax 51455 0
+61 8 8952 1557
Email 51455 0
[email protected]
Contact person for scientific queries
Name 51456 0
Wendy Anders
Address 51456 0
Institute of Koorie Education
Deakin university (Geelgong campus)
75 Pigdons road, Waurn Ponds Vic, 3216
Country 51456 0
Australia
Phone 51456 0
+61 3 5227 2724
Fax 51456 0
+61 3 52272019
Email 51456 0
[email protected]

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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