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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

Gao, Lan, Maddison, Ralph, Rawstorn, Jonathan, Ball, Kylie, Oldenburg, Brian, Chow, Clara, McNaughton, Sarah, Lamb, Karen, Amerena, John, Nadurata, Voltaire, Neil, Christopher, Cameron, Stuart and Moodie, Marj 2020, 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, BMJ open, vol. 10, no. 8, pp. 1-8, doi: 10.1136/bmjopen-2020-038178.

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Title 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
Author(s) Gao, LanORCID iD for Gao, Lan orcid.org/0000-0001-9734-1140
Maddison, RalphORCID iD for Maddison, Ralph orcid.org/0000-0001-8564-5518
Rawstorn, JonathanORCID iD for Rawstorn, Jonathan orcid.org/0000-0002-9755-7993
Ball, KylieORCID iD for Ball, Kylie orcid.org/0000-0003-2893-8415
Oldenburg, Brian
Chow, Clara
McNaughton, SarahORCID iD for McNaughton, Sarah orcid.org/0000-0001-5936-9820
Lamb, KarenORCID iD for Lamb, Karen orcid.org/0000-0001-9782-8450
Amerena, John
Nadurata, Voltaire
Neil, Christopher
Cameron, Stuart
Moodie, MarjORCID iD for Moodie, Marj orcid.org/0000-0001-6890-5250
Journal name BMJ open
Volume number 10
Issue number 8
Article ID e038178
Start page 1
End page 8
Total pages 8
Publisher BMJ Publishing Group
Place of publication London, Eng.
Publication date 2020-08-26
ISSN 2044-6055
2044-6055
Keyword(s) Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
health economics
rehabilitation medicine
myocardial infarction
coronary heart disease
Summary Introduction It is important to ascertain the cost-effectiveness of alternative services to traditional cardiac rehabilitation while the economic credentials of the Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) programme among people with coronary heart disease (CHD) are unknown. This economic protocol outlines the methods for undertaking a trial-based economic evaluation of SCRAM in the real-world setting in Australia. Methods and analysis The within-trial economic evaluation will be undertaken alongside a randomised controlled trial (RCT) designed to determine the effectiveness of SCRAM in comparison with the usual care cardiac rehabilitation (UC) alone in people with CHD. Pathway analysis will be performed to identify all the costs related to the delivery of SCRAM and UC. Both a healthcare system and a limited societal perspective will be adopted to gauge all costs associated with health resource utilisation and productivity loss. Healthcare resource use over the 6-month participation period will be extracted from administrative databases (ie, Pharmaceutical Benefits Scheme and Medical Benefits Schedule). Productivity loss will be measured by absenteeism from work (valued by human capital approach). The primary outcomes for the economic evaluation are maximal oxygen uptake (VO2max, mL/kg/min, primary RCT outcome) and quality-adjusted life years estimated from health-related quality of life as assessed by the Assessment of Quality of Life-8D instrument. The incremental cost-effectiveness ratio will be calculated using the differences in costs and benefits (ie, primary and secondary outcomes) between the two randomised groups from both perspectives with no discounting. All costs will be valued in Australian dollars for year 2020. Ethics and dissemination The study protocol has been approved under Australia’s National Mutual Acceptance agreement by the Melbourne Health Human Research Ethics Committee (HREC/18/MH/119). It is anticipated that SCRAM is a cost-effective cardiac telerehabilitation programme for people with CHD from both a healthcare and a limited societal perspective in Australia. The evaluation will provide evidence to underpin national scale-up of the programme to a wider population. The results of the economic analysis will be submitted for publication in a peer-reviewed journal. Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12618001458224).
Language eng
DOI 10.1136/bmjopen-2020-038178
Indigenous content off
Field of Research 1103 Clinical Sciences
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
HERDC Research category C1 Refereed article in a scholarly journal
Free to Read? Yes
Persistent URL http://hdl.handle.net/10536/DRO/DU:30141461

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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.