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      SMARTphone-based, early cardiac REHABilitation in patients with acute coronary syndromes [SMART-REHAB Trial]: a randomized controlled trial protocol

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          Abstract

          Background

          There are well-documented treatment gaps in secondary prevention of coronary heart disease and no clear guidelines to assist early physical activity after acute coronary syndromes (ACS). Smartphone technology may provide an innovative platform to close these gaps. This paper describes the study design of a randomized controlled trial assessing whether a smartphone-based secondary prevention program can facilitate early physical activity and improve cardiovascular health in patients with ACS.

          Methods

          We have developed a multi-faceted, patient-centred smartphone-based secondary prevention program emphasizing early physical activity with a graduated walking program initiated on discharge from ACS admission. The program incorporates; physical activity tracking through the smartphone’s accelerometer with interactive feedback and goal setting; a dynamic dashboard to review and optimize cardiovascular risk factors; educational messages delivered twice weekly; a photographic food diary; pharmacotherapy review; and support through a short message service. The primary endpoint of the trial is change in exercise capacity, as measured by the change in six-minute walk test distance at 8-weeks when compared to baseline. Secondary endpoints include improvements in cardiovascular risk factor status, psychological well-being and quality of life, medication adherence, uptake of cardiac rehabilitation and re-hospitalizations.

          Discussion

          This randomized controlled trial will use a smartphone-phone based secondary prevention program to emphasize early physical activity post-ACS. It will provide evidence regarding the feasibility and utility of this innovative platform in closing the treatment gaps in secondary prevention.

          Trial registration

          The trial was retrospectively registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) on April 4, 2016. The registration number is ACTRN12616000426482.

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          Most cited references21

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          Association of diet, exercise, and smoking modification with risk of early cardiovascular events after acute coronary syndromes.

          Although preventive drug therapy is a priority after acute coronary syndrome, less is known about adherence to behavioral recommendations. The aim of this study was to examine the influence of adherence to behavioral recommendations in the short term on risk of cardiovascular events. The study population included 18 809 patients from 41 countries enrolled in the Organization to Assess Strategies in Acute Ischemic Syndromes (OASIS) 5 randomized clinical trial. At the 30-day follow-up, patients reported adherence to diet, physical activity, and smoking cessation. Cardiovascular events (myocardial infarction, stroke, cardiovascular death) and all-cause mortality were documented to 6 months. About one third of smokers persisted in smoking. Adherence to neither diet nor exercise recommendations was reported by 28.5%, adherence to either diet or exercise by 41.6%, and adherence to both by 29.9%. In contrast, 96.1% of subjects reported antiplatelet use, 78.9% reported statin use, and 72.4% reported angiotensin-converting enzyme/angiotensin receptor blocker use. Quitting smoking was associated with a decreased risk of myocardial infarction compared with persistent smoking (odds ratio, 0.57; 95% confidence interval, 0.36 to 0.89). Diet and exercise adherence was associated with a decreased risk of myocardial infarction compared with nonadherence (odds ratio, 0.52; 95% confidence interval, 0.4 to 0.69). Patients who reported persistent smoking and nonadherence to diet and exercise had a 3.8-fold (95% confidence interval, 2.5 to 5.9) increased risk of myocardial infarction/stroke/death compared with never smokers who modified diet and exercise. Adherence to behavioral advice (diet, exercise, and smoking cessation) after acute coronary syndrome was associated with a substantially lower risk of recurrent cardiovascular events. These findings suggest that behavioral modification should be given priority similar to other preventive medications immediately after acute coronary syndrome. Clinical Trial Registration Information- URL: http://clinicaltrials.gov/ct2/show/NCT00139815. Unique identifier: NCT00139815.
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            SPIRIT 2013: new guidance for content of clinical trial protocols.

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              Telehealth interventions versus center-based cardiac rehabilitation of coronary artery disease: A systematic review and meta-analysis.

              Cardiac rehabilitation (CR) is an evidence-based recommendation for patients with coronary artery disease (CAD). However, CR is dramatically underutilized. Telehealth interventions have the potential to overcome barriers and may be an innovative model of delivering CR. This review aimed to determine the effectiveness of telehealth intervention delivered CR compared with center-based supervised CR.
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                Author and article information

                Contributors
                03 9496 5527 , matiasyudi@gmail.com
                Journal
                BMC Cardiovasc Disord
                BMC Cardiovasc Disord
                BMC Cardiovascular Disorders
                BioMed Central (London )
                1471-2261
                5 September 2016
                5 September 2016
                2016
                : 16
                : 1
                : 170
                Affiliations
                [1 ]Department of Cardiology, Austin Health, Melbourne, Australia
                [2 ]Department of Medicine, University of Melbourne, Melbourne, Australia
                [3 ]Department of Cardiology, Western Health, Melbourne, Australia
                [4 ]Department of Cardiology, St Vincent’s Hospital, Melbourne, Australia
                [5 ]Department of Heart and Mind, Australian Catholic University, Melbourne, Australia
                [6 ]Monash Heart, Monash Health, Melbourne, Australia
                [7 ]Department of Cardiology, Royal Melbourne Hospital, Melbourne, Australia
                [8 ]Department of Cardiology, Barwon Health, Geelong, Australia
                [9 ]School of Public Health, Curtin University, Perth, Western Australia Australia
                Article
                356
                10.1186/s12872-016-0356-6
                5011930
                27596569
                c611ec45-ccd5-4945-a820-7b593861f3a4
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 14 July 2016
                : 26 August 2016
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100001030, National Heart Foundation of Australia;
                Award ID: 101130
                Award ID: 101029
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/501100000925, National Health and Medical Research Council;
                Award ID: 1115163
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2016

                Cardiovascular Medicine
                cardiac rehabilitation,secondary prevention,acute coronary syndromes,mhealth,smartphone application

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