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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

Rawstorn, Jonathan Charles, Ball, Kylie, Oldenburg, Brian, Chow, Clara K, McNaughton, Sarah A, Lamb, Karen Elaine, Gao, Lan, Moodie, Marj, Amerena, John, Nadurata, Voltaire, Neil, Christopher, Cameron, Stuart and Maddison, Ralph 2020, 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, JMIR Research Protocols, vol. 9, no. 1, doi: 10.2196/15022.

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Title 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
Author(s) Rawstorn, Jonathan CharlesORCID iD for Rawstorn, Jonathan Charles orcid.org/0000-0002-9755-7993
Ball, KylieORCID iD for Ball, Kylie orcid.org/0000-0003-2893-8415
Oldenburg, Brian
Chow, Clara K
McNaughton, Sarah AORCID iD for McNaughton, Sarah A orcid.org/0000-0001-5936-9820
Lamb, Karen ElaineORCID iD for Lamb, Karen Elaine orcid.org/0000-0001-9782-8450
Gao, LanORCID iD for Gao, Lan orcid.org/0000-0001-9734-1140
Moodie, MarjORCID iD for Moodie, Marj orcid.org/0000-0001-6890-5250
Amerena, John
Nadurata, Voltaire
Neil, Christopher
Cameron, Stuart
Maddison, RalphORCID iD for Maddison, Ralph orcid.org/0000-0001-8564-5518
Journal name JMIR Research Protocols
Volume number 9
Issue number 1
Article ID ARTN e15022
Total pages 18
Publisher JMIR Publications
Place of publication Toronto, Ont.
Publication date 2020-01
ISSN 1929-0748
1929-0748
Keyword(s) Science & Technology
Life Sciences & Biomedicine
Health Care Sciences & Services
telemedicine
telerehabilitation
mHealth
myocardial ischemia
coronary artery disease
exercise
behavioral medicine
health services accessibility
costs and cost analysis
Summary 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.ObjectiveThe 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.MethodsIn 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.ResultsThe 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.ConclusionsThe 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 RegistrationAustralian 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
Language eng
DOI 10.2196/15022
Indigenous content off
Field of Research 1103 Clinical Sciences
1117 Public Health and Health Services
HERDC Research category C1 Refereed article in a scholarly journal
Free to Read? Yes
Persistent URL http://hdl.handle.net/10536/DRO/DU:30134804

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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.