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Effect of an assisted self-management program to prevent new life-threatening events post heart attack

Secondary Prevention for All in Need (SPAN) after Type 1 myocardial infarction: a comparative effectiveness randomised trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000316707
Acronym
SPAN
Enrollment
16
Registered
2022-02-21
Start date
2023-10-23
Completion date
2024-09-30
Last updated
2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Current national yearly data estimates 59,100 people aged 25 and over have a heart attack; around 162 events every day, including death. Despite advances in treatment, 15% of heart attack survivors have another heart attack, stroke or die within 12 months and 8.9% are unexpectedly readmitted to hospital within a year. The Secondary Prevention for All in Need (SPAN) trial will address the established evidence-practice gap that 7/10 heart attack survivors in Australia are not accessing guideline-advocated secondary prevention measures. Barriers to improving reach, completion and outcomes are complex and well-documented but can be addressed by studying more personalised ways of delivering prevention. This trial, where patients have an equal chance of receiving preventive treatment options, will evaluate the implementation of a published and flexible framework for improving secondary prevention amongst heart attack survivors; developed by three of the investigators. The SPAN trial involves comparing personalised rehabilitation with standard outpatient, group-based rehabilitation (or usual care). The SPAN framework offers a flexible, targeted and sustainable approach for risk factor control through shared decision-making and goal attainment. The trial will report on the differences between the two rehabilitation strategies in terms of completion defined as participation in greater than or equal to 80% of scheduled contacts as established at the initial engagement, and subsequently all admissions to hospital and death identified from administrative records at 1-year. We will determine if there is an absolute increase of at least 15% in the proportion of heart attack survivors that complete SPAN versus usual care; i.e. 65% vs 50% at medium three months, respectively. If successful this personalised rehabilitation strategy could be rapidly and widely implemented and would be expected to reduce the risk of recurrent cardiovascular events and unplanned readmissions to hospital nation-wide.

Interventions

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

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.

Sponsors

The University of Western Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026