JMIR Publications

ABSTRACT

Background:

Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistently low utilisation of traditional centre-based programs. Use of contemporary digital technologies to deliver CR intervention support could significantly improve current poor reach and fidelity.

Objective:

This trial is comparing effects and costs of the innovative Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) intervention with usual care CR.

Methods:

In this multi-centre, investigator-blinded randomised controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from three hospitals in metropolitan and regional Victoria, Australia, and randomised (1:1) to receive usual care CR alone or usual care CR plus the 24-week SCRAM intervention. All participants are offered access to usual care CR services offered by their local CR provider. SCRAM is a dual-phase intervention that includes 1) 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists followed by 12 weeks of non-real-time remote coaching, and 2) 24 weeks of evidence- and theory-based behaviour change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviours (healthy diet, physical activity/sedentary behaviour, stress management, smoking cessation), health-related quality of life, and adverse events. An economic evaluation and process analysis will determine cost-effectiveness and participant perceptions of the treatment arms, respectively.

Results:

The trial was funded in November 2017, received ethical approval in June 2018, and recruitment began in November 2018. As of June 2019, 33 participants have been randomised into the trial.

Conclusions:

The innovative multi-phase SCRAM intervention can deliver real-time remote exercise supervision and evidence-based self-management behavioural support to participants, regardless of their geographic proximity to traditional centre-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important for informing healthcare providers about the potential for innovative program delivery models like SCRAM to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort that includes metropolitan-, regional-, and rural-dwelling participants will also facilitate understanding the role of this delivery model across multiple geographic locations and healthcare settings with diverse needs. Clinical Trial: Registered with the Australian New Zealand Clinical Trials Registry on 30/08/2018 (ACTRN12618001458224).