Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000316707
Ethics application status
Approved
Date submitted
10/12/2021
Date registered
21/02/2022
Date last updated
30/11/2023
Date data sharing statement initially provided
21/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of an assisted self-management program to prevent new life-threatening events post heart attack
Scientific title
Secondary Prevention for All in Need (SPAN) after Type 1 myocardial infarction: a comparative effectiveness randomised trial
Secondary ID [1] 305978 0
ID105531
Universal Trial Number (UTN)
Trial acronym
SPAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 myocardial infarction 324599 0
Condition category
Condition code
Cardiovascular 322055 322055 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SPAN intervention is a flexible framework for secondary prevention after a heart attack providing a minimum level of health service standardisation. It can be delivered across any health area service regardless of a patient’s age, gender, ethnicity, geographical location or socioeconomic position. Patients continue to receive their routine care, including usual pharmacotherapy and lifestyle advice at the discretion of their treating clinicians, whilst receiving the four preventative pillars of education, assessment, individual risk management planning, and supplementary follow-up. Study materials will be adapted from earlier trials (CHOICE Trial Redfern et al, Heart 2008 Sydney University ANZAC Research Institute, Concord Hospital ISRCTN42984084; CHOICE+ Neubeck et al, HLC 2018, Sydney University, ANZAC Research Institute, Concord Hospital, ACTRN12608000182392) to reflect advances in remote monitoring and technology. Use of these resources and associated intensity is at the discretion of the participant. There is no pre-specified template for the number or duration of sessions or the timing as to when they occur in the 12 weeks. The format of delivery is precision-tailored content, with setting and method of contact depending on patient need, access, preference and goals. Each patient will work with a study trained secondary prevention health professional to develop a mutually agreed schedule of contacts, strategies and goals for their personal preventive care. This is bookended by induction - mean 50 minutes - and close-out clinic visit/telephone calls - mean 30 minutes. At induction, participants are familiarised with their modifiable risk factors for new events and the options available for management should they elect to do so. All baseline data for the study will be collected at this time. At close-out, a review of the participants performance against the agreed schedule at baseline will take place. In between, patients will receive lipid-lowering and evidence-based medications (subject to contraindication and intolerance) and optional choice of additional content covering disease progression, lifestyle education, psychosocial support, and information to assist in addressing risk factors such as elevated blood pressure, raised cholesterol, physical inactivity and cigarette smoking. Further, participants can elect to engage in up to a median of 3 x 20-minute (range 5-35 minutes) phone calls with the secondary prevention coordinator to monitor progress. The intervention will commence within 2-4 weeks of leaving hospital and provides a median of 3 contacts (range 1-5) over 12 weeks. The expected overall time spent on telephone follow-up will range from 5-105 minutes with a median of 30 minutes per participant. Adherence to the intervention will be assessed during the close-out visit based on the number of ‘activities’ completed and scheduled calls that took place, compared to what was scheduled in the personalised rehabilitation plan developed by the patient and secondary prevention coordinator during the induction visit.
Intervention code [1] 322373 0
Rehabilitation
Intervention code [2] 322374 0
Prevention
Comparator / control treatment
The control group will receive routine cardiac care at the discretion of their treating team, which includes pharmacotherapy, genetic risk factor education, referral to outpatient group-based rehabilitation and medical review as per local practice.
Control group
Active

Outcomes
Primary outcome [1] 329814 0
Proportion of patients completing at least 80% of all scheduled sessions (yes/no) for standard outpatient rehabilitation versus SPAN. This will be extracted from either hard copy or electronic medical records documented as part of normal clinical responsibilities and from direct access to the personalised rehabilitation plan template and follow-up case report form (CRF) kept by the secondary prevention coordinator, and assessed using a logistic regression analysis with stratification by site.
Timepoint [1] 329814 0
Median of 3 months follow-up at the time of intervention completion.
Secondary outcome [1] 403940 0
Level of health service utilisation as assessed by data linkage to health service records.
Timepoint [1] 403940 0
Median of 12 months follow-up assessed from the time of intervention commencement to 12 months post-intervention commencement.
Secondary outcome [2] 403941 0
Adherence to guideline indicated medications as assessed by data linkage to medical records.
Timepoint [2] 403941 0
Median of 12 months follow-up assessed from the time of intervention commencement to 12 months post-intervention commencement.
Secondary outcome [3] 403942 0
All-cause death as assessed by data linkage to the National Health Index.
Timepoint [3] 403942 0
Median of 12 months follow-up assessed from the time of intervention commencement to 12 months post-intervention commencement.

Eligibility
Key inclusion criteria
Persons aged at least 18 years;
Inpatient diagnosis of suspected ST-segment elevation MI (STEMI), or high-risk and intermediate-risk non-STEMI (NSTEMI) acute coronary syndrome by ACS Guidelines and 4th universal definition of MI. Specifically, Troponin Pattern 1 (Acute Myocardial Injury): A rise and/or fall in troponin from at least 2 samples defined as: (1) Hs-Troponin T: A rise and/or fall in the absolute troponin level of >2.5ng/L/hour (ie a change of >15ng/L in 6 hours) between any troponin results before randomisation OR a relative change in troponin >20% between earlier and later samples (ie 100*(hs-TnT[later] - hs-TnT[earlier] / hs-TnT[earlier]) >20%) documented on any troponin results before randomisation. (2) Hs-Troponin I: An absolute elevation of >10 times the upper limit of normal specific for that assay, using gender-specific cut-points if implemented locally OR change in troponin >20% between earlier and later samples (ie 100*(hs-TnI[later] - hs-TnI[earlier] / hs-TnI[earlier]) >20% documented on any troponin results before randomisation;
Regarded by the treating cardiologist to be suitable for cardiac rehabilitation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior cardiac rehabilitation;
Clinical diagnosis of uncompensated severe heart failure (Class IV);
Uncontrolled arrhythmia or angina;
Severe or symptomatic aortic stenosis;
Co-existing clinical diagnosis of non-cardiac condition that would prevent participation (eg advanced dementia, severe rheumatoid arthritis, severe frailty, terminal illness).

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 concealed and randomisation performed on central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is at the level of the individual in blocks of four within site upon confirmation of Type 1 MI. It will be done centrally utilising a computer-generated random allocation sequence in a uniform 1:1 allocation ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The trial will be reported according to Consolidated Standards of Reporting Trials (CONSORT) guidelines. Summary statistics including means and standard deviations or counts and percentages will be calculated for all baseline characteristics by treatment arm. Differences in demographic and clinical characteristics between groups at baseline, 3 months (primary endpoint) and 12 months (secondary endpoint) will be compared using t-tests, Mann-Whitney U-tests or Chi-squared tests as appropriate.

Primary Outcome
The primary analysis will be based on the intention-to-treat principle. A chart showing the flow of participants through the trial and reasons for drop out will be provided. The primary outcome of meeting at least 80% participation of all scheduled sessions (yes/ no) for outpatient rehabilitation versus SPAN will be assessed using a logistic regression analysis with stratification by site. Potential confounding variables based on baseline clinical data will be considered in the analyses.

Secondary outcomes
The time to event analysis, including the composite of readmission to hospital for MI, stroke or all-cause death will be based on a Cox proportional hazards regression model, with stratification by site. Hazard ratios comparing the two interventions, with corresponding 95% confidence intervals will be calculated for this model and the log-rank test will be used to compare the groups.

All other binary and continuous outcomes will be analysed using logistic regression and linear regression respectively with stratification by site.

A modified intent-to-treat analysis will also be performed where only those who achieved a minimum exposure to outpatient rehabilitation, defined as attendance at one or more sessions after induction to the program and a minimum exposure to personalised rehabilitation, defined as one contact; i.e. induction session, with the secondary prevention health professional will be included.

Multiple imputation will be used where appropriate and two-tailed p-values < 0.05 will be considered statistically significant.

Sample Size & Power:
The six participating tertiary centres report aggregated annual admissions for MI exceeding 5,000 (range 720 - 950/hospital). All eligible participants will be identified by study personnel from daily admissions to coronary care and general medical units. Sites are required to enrol on average nine patients a month for one year.

Assuming a power of 90% and an overall Type one error of 5%, we expect that 50% of those randomised to usual care will meet the primary endpoint compared to 65% of those on SPAN. To detect this difference of 15%, we require a sample size of 478 (239 per arm) participants. Assuming that 25% of participants will crossover and an attrition rate of 10%, the total sample size required is 640.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
23/10/2023
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
650
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 21280 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 21283 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 21284 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [4] 21285 0
Concord Repatriation Hospital - Concord
Recruitment hospital [5] 21286 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 36149 0
6000 - Perth
Recruitment postcode(s) [2] 36152 0
5042 - Bedford Park
Recruitment postcode(s) [3] 36153 0
3168 - Clayton
Recruitment postcode(s) [4] 36154 0
2139 - Concord
Recruitment postcode(s) [5] 36155 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 310318 0
Charities/Societies/Foundations
Name [1] 310318 0
National Heart Foundation of Australia
Country [1] 310318 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Highway
Crawley, WA 6009
Country
Australia
Secondary sponsor category [1] 311443 0
None
Name [1] 311443 0
Address [1] 311443 0
Country [1] 311443 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309981 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 309981 0
Ethics committee country [1] 309981 0
Australia
Date submitted for ethics approval [1] 309981 0
16/09/2022
Approval date [1] 309981 0
19/09/2022
Ethics approval number [1] 309981 0
2022/HRE00071

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

Contacts
Principal investigator
Name 116066 0
Prof Tom Briffa
Address 116066 0
The University of Western Australia
M431/1.19, Clifton Street Building
35 Stirling Highway, Crawley WA 6009
Country 116066 0
Australia
Phone 116066 0
+61 8 6488 1292
Fax 116066 0
Email 116066 0
[email protected]
Contact person for public queries
Name 116067 0
Tom Briffa
Address 116067 0
The University of Western Australia
M431/1.19, Clifton Street Building
35 Stirling Highway, Crawley WA 6009
Country 116067 0
Australia
Phone 116067 0
+61 8 6488 1292
Fax 116067 0
Email 116067 0
[email protected]
Contact person for scientific queries
Name 116068 0
Tom Briffa
Address 116068 0
The University of Western Australia
M431/1.19, Clifton Street Building
35 Stirling Highway, Crawley WA 6009
Country 116068 0
Australia
Phone 116068 0
+61 8 6488 1292
Fax 116068 0
Email 116068 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
De-identified individual participant data will not be available for this study. There is not consent for IPD to be shared. Moreover, this research project uses data obtained from a third-party source under strict privacy and confidentiality agreements from the Western Australian Department of Health (State) and Australian Department of Health (Federal) databases, which are governed by their ethics committees and data custodians. The data will be provided after approval is granted from their standard application processes for access to the linked datasets. Therefore, any requests to share these data with other researchers will be subject to formal approval from the third-party ethics committees and data custodian(s). Researchers interested in these data should contact the Data Services Team at the Data Linkage Branch of the Western Australian Department of Health (www.datalinkage-wa.org.au/contact-us).


What supporting documents are/will be available?

No Supporting Document Provided



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.