SMARTphone and social media-based Cardiac Rehabilitation and Secondary Prevention (SMART-CR/SP) for patients with coronary heart disease in China: a randomised controlled trial protocol

Tashi Dorje, Gang Zhao, Anna Scheer, Lhamo Tsokey, Jing Wang, Yaolin Chen, Khandro Tso, B-K Tan, Junbo Ge, Andrew Maiorana, Tashi Dorje, Gang Zhao, Anna Scheer, Lhamo Tsokey, Jing Wang, Yaolin Chen, Khandro Tso, B-K Tan, Junbo Ge, Andrew Maiorana

Abstract

Introduction: The burden of cardiovascular disease (CVD) is rapidly increasing in developing countries, however access to cardiac rehabilitation and secondary prevention (CR/SP) in these countries is limited. Alternative delivery models that are low-cost and easy to access are urgently needed to address this service gap. The objective of this study is to investigate whether a smartphone and social media-based (WeChat) home CR/SP programme can facilitate risk factor monitoring and modification to improve disease self-management and health outcomes in patients with coronary heart disease (CHD), after percutaneous coronary intervention (PCI) therapy.

Methods and analysis: We propose a single-blind, randomised controlled trial of 300 patients post-PCI with follow-up over 12 months. The intervention group will receive a smartphone-based and WeChat-based CR/SP programme providing education and support for risk factor monitoring and modification. SMART-CR/SP incorporates core components of modern CR/SP: physical activity tracking with interactive feedback and goal setting; education modules addressing CHD understanding and self-management; remote blood pressure monitoring and strategies to improve medication adherence. Furthermore, a dedicated data portal and a CR/SP coach will facilitate individualised supervision and counselling. The control group will receive usual care but no formal CR/SP programme. The primary outcome is change in exercise capacity measured by 6 minute walk test distance. Secondary outcomes include knowledge and awareness of CHD, risk factor status, medication adherence, psychological well-being and quality of life, major cardiovascular events, re-hospitalisations and all-cause mortality. To assess the feasibility and patients' acceptance of the intervention, a process evaluation will be performed at the conclusion of the study.

Ethics and dissemination: Ethics approval was granted by both the Human Research Ethics Committee of Fudan University Zhongshan Hospital (HREC B2016-058) and Curtin University Human Research Ethics Office (HRE2016-0120). Results will be disseminated via peer-reviewed publications and presentations at conferences.

Clinical trial registration number: ChiCTR-INR-16009598; Pre-results.

Keywords: cardiac rehabilitation; coronary heart disease; secondary prevention; social media; wechat.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Randomised controlled trial design and flowchart. The control group will receive usual care but no formal CR/SP. The intervention group will receive a smartphone and WeChat-based CR/SP programme providing education and support for risk factor monitoring and modification. CHD, coronary heart disease; CR/SP, cardiac rehabilitation/secondary prevention; CVD, cardiovascular disease; LDL, low-density lipoprotein; 6MWT, 6 min walk test; PCI, percutaneous coronary intervention.
Figure 2
Figure 2
Components of the Smart-CR/SP system. SMART-CR/SP incorporates core components of modern CR/SP: physical activity tracking with interactive feedback and goal setting; education modules addressing CHD understanding and self-management; remote blood pressure monitoring and strategies to improve medication adherence. Furthermore, a dedicated data portal and a CR/SP coach will facilitate individualised supervision and counselling. CHD, coronary heart disease; CR/SP, cardiac rehabilitation and secondary prevention.
Figure 3
Figure 3
WeChat-based CR/SP system interface depicting health education (A), physical activity tracking (B), blood pressure monitoring (C), cholesterol management (D), medication management (E), individual counselling (F), smoking secession (G), mental health (H). CR/SP, cardiac rehabilitation and secondary prevention.

References

    1. Weiwei C, Runlin G, Lisheng L, et al. . Outline of the report on cardiovascular diseases in China 2016. China Journal of Circulation 2017;32:521–30.
    1. Bi Y, Jiang Y, He J, et al. . Status of cardiovascular health in Chinese adults. J Am Coll Cardiol 2015;65:1013–25. 10.1016/j.jacc.2014.12.044
    1. Moran A, Gu D, Zhao D, et al. . Future cardiovascular disease in china: markov model and risk factor scenario projections from the coronary heart disease policy model-china. Circ Cardiovasc Qual Outcomes 2010;3:243–52. 10.1161/CIRCOUTCOMES.109.910711
    1. Yusuf S. Two decades of progress in preventing vascular disease. Lancet 2002;360:2–3. 10.1016/S0140-6736(02)09358-3
    1. Clark AM, Hartling L, Vandermeer B, et al. . Secondary prevention programmes for coronary heart disease: a meta-regression showing the merits of shorter, generalist, primary care-based interventions. Eur J Cardiovasc Prev Rehabil 2007;14:538–46. 10.1097/HJR.0b013e328013f11a
    1. Frederix I, Hansen D, Coninx K, et al. . Effect of comprehensive cardiac telerehabilitation on one-year cardiovascular rehospitalization rate, medical costs and quality of life: a cost-effectiveness analysis. Eur J Prev Cardiol 2016;23 10.1177/2047487315602257
    1. Anderson L, Oldridge N, Thompson DR, et al. . Exercise-based cardiac rehabilitation for coronary heart disease: cochrane systematic review and meta-analysis. J Am Coll Cardiol 2016;67:1–12. 10.1016/j.jacc.2015.10.044
    1. Pack QR, Squires RW, Lopez-Jimenez F, et al. . Participation rates, process monitoring, and quality improvement among cardiac rehabilitation programs in the united states: a national survey. J Cardiopulm Rehabil Prev 2015;35:173–80. 10.1097/HCR.0000000000000108
    1. Laukkanen JA. Cardiac rehabilitation: why is it an underused therapy? Eur Heart J 2015;36:1500–1. 10.1093/eurheartj/ehv138
    1. Jelinek MV, Thompson DR, Ski C, et al. . 40 years of cardiac rehabilitation and secondary prevention in post-cardiac ischaemic patients. Are we still in the wilderness? Int J Cardiol 2015;179:153–9. 10.1016/j.ijcard.2014.10.154
    1. Berry JD. Preventive cardiology update: controversy, consensus, and future promise. Prog Cardiovasc Dis 2015;58:1–2. 10.1016/j.pcad.2015.05.005
    1. Chew DP, French J, Briffa TG, et al. . Acute coronary syndrome care across Australia and New Zealand: the SNAPSHOT ACS study. Med J Aust 2013;199:185–91. 10.5694/mja12.11854
    1. Shanmugasegaram S, Perez-Terzic C, Jiang X, et al. . Cardiac rehabilitation services in low- and middle-income countries: a scoping review. J Cardiovasc Nurs 2014;29:454–63. 10.1097/JCN.0b013e31829c1414
    1. Turk-Adawi K, Sarrafzadegan N, Grace SL. Global availability of cardiac rehabilitation. Nat Rev Cardiol 2014;11:586–96. 10.1038/nrcardio.2014.98
    1. Zhang Z, Pack Q, Squires RW, et al. . Availability and characteristics of cardiac rehabilitation programmes in China. Heart Asia 2016;8:9–12. 10.1136/heartasia-2016-010758
    1. Wang W, Chair SY, Thompson DR, et al. . Health care professionals' perceptions of hospital-based cardiac rehabilitation in mainland China: an exploratory study. J Clin Nurs 2009;18:3401–8. 10.1111/j.1365-2702.2009.02876.x
    1. Jin H, Wei Q, Chen L, et al. . Obstacles and alternative options for cardiac rehabilitation in Nanjing, China: an exploratory study. BMC Cardiovasc Disord 2014;14:20 10.1186/1471-2261-14-20
    1. Varnfield M, Karunanithi M, Lee CK, et al. . Smartphone-based home care model improved use of cardiac rehabilitation in postmyocardial infarction patients: results from a randomised controlled trial. Heart 2014;100:1770–9. 10.1136/heartjnl-2014-305783
    1. Neubeck L, Redfern J, Fernandez R, et al. . Telehealth interventions for the secondary prevention of coronary heart disease: a systematic review. Eur J Cardiovasc Prev Rehabil 2009;16:281–9. 10.1097/HJR.0b013e32832a4e7a
    1. Rawstorn JC, Gant N, Direito A, et al. . Telehealth exercise-based cardiac rehabilitation: a systematic review and meta-analysis. Heart 2016;102:1183–92. 10.1136/heartjnl-2015-308966
    1. Szalewska D, Zieliński P, Tomaszewski J, et al. . Effects of outpatient followed by home-based telemonitored cardiac rehabilitation in patients with coronary artery disease. Kardiol Pol 2015;73:1101–7. 10.5603/KP.a2015.0095
    1. Zhao J, Freeman B, Li M. Can mobile phone apps influence people’s health behavior change? An evidence review. J Med Internet Res 2016;18:e287 10.2196/jmir.5692
    1. West JH, Belvedere LM, Andreasen R, et al. . Controlling your "App"etite: how diet and nutrition-related mobile apps lead to behavior change. JMIR Mhealth Uhealth 2017;5:e95 10.2196/mhealth.7410
    1. Pfaeffli Dale L, Whittaker R, Jiang Y, et al. . Text message and internet support for coronary heart disease self-management: results from the text4heart randomized controlled trial. J Med Internet Res 2015;17:e237 10.2196/jmir.4944
    1. Interlligence P. WeChat 2017 user research and business opportunities insight. 2016.
    1. He C, Wu S, Zhao Y, et al. . Social media-promoted weight loss among an occupational population: cohort study using a wechat mobile phone app-based campaign. J Med Internet Res 2017;19:e357 10.2196/jmir.7861
    1. Chan AW, Tetzlaff JM, Altman DG, et al. . SPIRIT 2013: new guidance for content of clinical trial protocols. Lancet 2013;381:91–2. 10.1016/S0140-6736(12)62160-6
    1. Chan AW, Tetzlaff JM, Altman DG, et al. . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Rev Panam Salud Publica 2015;38:506–14.
    1. Chan AW, Tetzlaff JM, Gøtzsche PC, et al. . SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586 10.1136/bmj.e7586
    1. Casillas JM, Hannequin A, Besson D, et al. . Walking tests during the exercise training: specific use for the cardiac rehabilitation. Ann Phys Rehabil Med 2013;56:561–75. 10.1016/j.rehab.2013.09.003
    1. Gremeaux V, Troisgros O, Benaïm S, et al. . Determining the minimal clinically important difference for the six-minute walk test and the 200-meter fast-walk test during cardiac rehabilitation program in coronary artery disease patients after acute coronary syndrome. Arch Phys Med Rehabil 2011;92:611–9. 10.1016/j.apmr.2010.11.023
    1. Beatty AL, Schiller NB, Whooley MA. Six-minute walk test as a prognostic tool in stable coronary heart disease: data from the heart and soul study. Arch Intern Med 2012;172:1096–102. 10.1001/archinternmed.2012.2198
    1. Woodruffe S, Neubeck L, Clark RA, et al. . Australian Cardiovascular Health and Rehabilitation Association (ACRA) core components of cardiovascular disease secondary prevention and cardiac rehabilitation 2014. Heart Lung Circ 2015;24:430–41. 10.1016/j.hlc.2014.12.008
    1. Kaminsky LA, Brubaker PH, Guazzi M, et al. . Assessing physical activity as a core component in cardiac rehabilitation: a position statement of the american association of cardiovascular and pulmonary rehabilitation. J Cardiopulm Rehabil Prev 2016;36:217–29. 10.1097/HCR.0000000000000191
    1. Organization WH. Physical status: the use and interpretation of anthropometry Geneva, 1995.
    1. Gabb GM, Mangoni AA, Anderson CS, et al. . Guideline for the diagnosis and management of hypertension in adults - 2016. Med J Aust 2016;205:85–9. 10.5694/mja16.00526
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010
    1. Wang SS, Lay S, Yu HN, et al. . Dietary guidelines for chinese residents (2016): comments and comparisons. J Zhejiang Univ Sci B 2016;17:649–56. 10.1631/jzus.B1600341
    1. Smith SC, Benjamin EJ, Bonow RO, et al. . AHA/ACCF secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation. Circulation 2011;124:2458–73. 10.1161/CIR.0b013e318235eb4d
    1. Piepoli MF, Hoes AW, Agewall S, et al. . 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J 2016;37:2315–81. 10.1093/eurheartj/ehw106
    1. Singh SJ, Puhan MA, Andrianopoulos V, et al. . An official systematic review of the European Respiratory Society/American Thoracic Society: measurement properties of field walking tests in chronic respiratory disease. Eur Respir J 2014;44:1447–78. 10.1183/09031936.00150414
    1. Chan CW, Lopez V, Chung JW. A survey of coronary heart disease knowledge in a sample of Hong Kong Chinese. Asia Pac J Public Health 2011;23:288–97. 10.1177/1010539509345869
    1. Wagner J, Lacey K, Chyun D, et al. . Development of a questionnaire to measure heart disease risk knowledge in people with diabetes: the Heart Disease Fact Questionnaire. Patient Educ Couns 2005;58:82–7. 10.1016/j.pec.2004.07.004
    1. Edwards P, Williams-Roberts H, Sahely B, et al. . The WHO STEPwise approach to chronic disease risk factor surveillance (STEPS). Geneva: World Health Organisation, 2008.
    1. Heatherton TF, Kozlowski LT, Frecker RC, et al. . The fagerström test for nicotine dependence: a revision of the fagerström tolerance questionnaire. Br J Addict 1991;86:1119–27. 10.1111/j.1360-0443.1991.tb01879.x
    1. World Health Organisation. Global Physical Activity Questionnaire (GPAQ) analysis guide. 2011. .
    1. Spitzer RL, Kroenke K, Williams JB, et al. . A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006;166:1092–7. 10.1001/archinte.166.10.1092
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001;16:606–13.
    1. Ware J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996;34:220–33.

Source: PubMed

3
Abonnieren