Smartphone Cardiac Rehabilitation, Assisted Self-Management Versus Usual Care: Protocol for a Multicenter Randomized Controlled Trial to Compare Effects and Costs Among People With Coronary Heart Disease

Abstract

Background Alternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs. Objective The aim of this study is to compare the effects and costs of the innovative Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) intervention with usual care CR. Methods In this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively. Results The trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial. Conclusions The innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-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 to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs. Trial Registration Australian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508. International Registered Report Identifier (IRRID) DERR1-10.2196/15022

Economic evaluation protocol for a multicentre randomised controlled trial to compare Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) versus usual care cardiac rehabilitation among people with coronary heart disease

“…The details of the study design are reported elsewhere. 23 Briefly, SCRAM is a multicentre investigator-blinded, assessor-blinded and statistician-blinded parallel two-arm RCT comparing effects and costs of the 24-week SCRAM intervention with usual care CR. A process evaluation is also being undertaken.…”

“…Minimum detectable differences in secondary RCT outcomes are outlined in the main trial protocol. 23 baseline assessment Prior to randomisation, researchers collect the following information: sociodemographic and clinical (diagnostic, smoking, alcohol history and medication) characteristics, eHealth literacy (a questionnaire), VȮ 2 max and secondary outcomes (detailed below).…”

“…The within-trial economic evaluation will be based on the intention-to-treat population as per the primary outcome of the RCT. 23 In particular, completers data will be used for the base-case analysis, whereas the imputed data analysis (using multiple missing data imputation approach, with the assumption that missingness is at random) will be undertaken to examine the robustness of base-case results. All evaluation results will be expressed as incremental results over and above the comparator case.…”

“…To establish the economic credentials of the SCRAM programme in the Australian setting, an economic evaluation will be conducted to examine the balance between health effects and costs of health technologies (ie, SCRAM programme, medications, diagnostic tests and medical services) to inform efficient allocation of limited healthcare funding. In response to the transparent reporting of clinical trials, this paper outlines the methods of the prospective within-trial economic evaluation to be undertaken alongside the RCT, 23 to provide important evidence for policy decision-making around the provision of CR services. It will include both cost-effectiveness and cost-utility analysis (CUA) with a view to informing resource allocation, practice change and investment in the SCRAM programme.…”

“…VȮ 2 max is measured at baseline and 24-week follow-up, while HRQoL is assessed at baseline, 12 and 24 weeks. Secondary outcomes, including modifiable cardiovascular risk factors and adverse events, are described in the main trial protocol 23. …”