Design and rationale of the tobacco, exercise and diet messages (TEXT ME) trial of a text message-based intervention for ongoing prevention of cardiovascular disease in people with coronary disease: a randomised controlled trial protocol

C K Chow, J Redfern, A Thiagalingam, S Jan, R Whittaker, M Hackett, N Graves, J Mooney, G S Hillis, C K Chow, J Redfern, A Thiagalingam, S Jan, R Whittaker, M Hackett, N Graves, J Mooney, G S Hillis

Abstract

Background Although supporting lifestyle change is an effective way of preventing further events in people with cardiovascular disease, providing access to such interventions is a major challenge. This study aims to investigate whether simple reminders about behaviour change sent via mobile phone text message decrease cardiovascular risk. Methods and analysis Randomised controlled trial with 6 months of follow-up to evaluate the feasibility, acceptability and effect on cardiovascular risk of repeated lifestyle reminders sent via mobile phone text messages compared to usual care. A total of 720 patients with coronary artery disease will be randomised to either standard care or the TEXT ME intervention. The intervention group will receive multiple weekly text messages that provide information, motivation, support to quit smoking (if relevant) and recommendations for healthy diets and exercise. The primary end point is a change in plasma low-density lipoprotein cholesterol at 6 months. Secondary end points include a change in systolic blood pressure, smoking status, quality of life, medication adherence, waist circumference, physical activity levels, nutritional status and mood at 6 months. Process outcomes related to acceptability and feasibility of TEXT ME will also be collected. Ethics and dissemination Primary ethics approval was received from Western Sydney Local Health Network Human Research Ethics Committee-Westmead. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences. Clinical trials registration number ACTRN12611000161921.

Conflict of interest statement

Competing interests: None.

Figures

Figure 1
Figure 1
Study design and flow. ACS, acute coronary syndrome; CAD, coronary artery disease; CV, cardiovascular.

References

    1. World Health Organisation The Top 10 Causes of Death. 2008. Fact sheet N°310. (accessed 16 Feb 2010).
    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
    1. Beswick AD, Rees K, Griebsch I, et al. Provision, uptake and cost of cardiac rehabilitation programmes: improving services to under-represented groups. Health Technol Assess 2004;8:1–152
    1. Suaya JA, Shepard DS, Normand SL, et al. Use of cardiac rehabilitation by Medicare beneficiaries after myocardial infarction or coronary bypass surgery. Circulation 2007;116:1653–62
    1. Chow CK, Jolly S, Rao-Melacini P, et al. Association of diet, exercise, and smoking modification with risk of early cardiovascular events after acute coronary syndromes. Circulation 2010;121:750–8
    1. Clark AM, Hartling L, Vandermeer B, et al. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med 2005;143:659–72
    1. Briffa TG, Kinsman L, Maiorana AJ, et al. An integrated and coordinated approach to preventing recurrent coronary heart disease events in Australia: a policy statement from the Australian cardiovascular health and rehabilitation association. Med J Aust 2009;190:683–6
    1. Scott IA, Lindsay KA, Harden HE. Utilisation of outpatient cardiac rehabilitation in Queensland. Med J Aust 2003;179:341–5
    1. Redfern J, Ellis ER, Briffa T, et al. High risk-factor level and low risk-factor knowledge in patients not accessing cardiac rehabilitation after acute coronary syndrome. Med J Aust 2007;186:21–5
    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
    1. Dobbels F, De Geest S, Vanhees L, et al. Depression and the heart: a systematic overview of definition, measurement, consequences and treatment of depression in cardiovascular disease. Eur J Cardiovasc Nurs 2002;1:45–55
    1. Gierach GL, Loud JT, Chow CK, et al. Mammographic density does not differ between unaffected BRCA1/2 mutation carriers and women at low-to-average risk of breast cancer. Breast Cancer Res Treat 2010;123:245–55
    1. Koivusilta LK, Lintonen TP, Rimpela AH. Orientations in adolescent use of information and communication technology: a digital divide by sociodemographic background, educational career, and health. Scand J Public Health 2007;35:95–103
    1. Leena K, Tomi L, Arja RR. Intensity of mobile phone use and health compromising behaviours—how is information and communication technology connected to health-related lifestyle in adolescence? J Adolesc 2005;28:35–47
    1. Atun RA, Greene SA, Morris S, et al. The role of mobile phones in increasing accessibility and efficiency in healthcare. Moving the debate forward: The Vodaphone Policy Paper Series No. 4. March 2006. Vodaphone Group Plc.
    1. Franklin VL, Waller A, Pagliari C, et al. A randomized controlled trial of Sweet Talk, a text-messaging system to support young people with diabetes. Diabet Med 2006;23:1332–8
    1. Marquez Contreras E, de la Figuera von Wichmann M, Gil Guillen V, et al. Effectiveness of an intervention to provide information to patients with hypertension as short text messages and reminders sent to their mobile phone (HTA-Alert). Aten Primaria 2004;34:399–405
    1. Smith SC., Jr Current and future directions of cardiovascular risk prediction. Am J Cardiol 2006;97:28A–32A
    1. Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med 2009;36:165–73
    1. Whittaker R, Borland R, Bullen C, et al. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev 2009;(4):CD006611.
    1. Patrick K, Raab F, Adams MA, et al. A text message-based intervention for weight loss: randomized controlled trial. J Med Internet Res 2009;11:e1.
    1. Hurling R, Catt M, Boni MD, et al. Using internet and mobile phone technology to deliver an automated physical activity program: randomized controlled trial. J Med Internet Res 2007;9:e7.
    1. Heart Foundation of Australia Healthy Living. 2009. (accessed 11 Mar 2010).
    1. Free C, Whittaker R, Knight R, et al. Txt2stop: a pilot randomised controlled trial of mobile phone-based smoking cessation support. Tob Control 2009;18:88–91
    1. Whittaker R, Maddison R, McRobbie H, et al. A multimedia mobile phone-based youth smoking cessation intervention: findings from content development and piloting studies. J Med Internet Res 2008;10:e49.
    1. Patel A, MacMahon S, Chalmers J, et al. ; ADVANCE Collaborative Group Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008;358:2560–72
    1. World Health Organisation Global Physical Activity Questionnaire (GPAQ) Analysis Guide. 2011. (accessed 7 Sep 2011).
    1. Cunnington AJ, Hormbrey P. Breath analysis to detect recent exposure to carbon monoxide. Postgrad Med J 2002;78:233–7
    1. Ware J, Kosinski M, Keller S. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996;34:220–33
    1. Williams LS, Brizendine EJ, Plue L, et al. Performance of the PHQ-9 as a screening tool for depression after stroke. Stroke 2005;36:635–8
    1. Morse JM. The significance of saturation. Qual Health Res 1995;5:147–9
    1. Drummond MF, Sculpher MJ, Torrance GW, et al. Methods for the Economic Evaluation of Health Care Programmes. 3rd edn Oxford: Oxford University Press, 2005
    1. Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ 2002;21:271–92
    1. Clarke PM, Glasziou P, Patel A, et al. Event rates, hospital Utilization, and costs associated with major Complications of diabetes: a multicountry comparative analysis. PLoS Med 2010;7:e1000236.
    1. Graves N, McKinnon L, Reeves M, et al. Cost-effectiveness analyses and modelling the lifetime costs and benefits of health-behaviour interventions. Chronic Illn 2006;2:97–107
    1. Vale MJ, Jelinek MV, Best JD, et al. Coaching patients On Achieving Cardiovascular Health (COACH): a multicenter randomized trial in patients with coronary heart disease. Arch Intern Med 2003;163:2775–83

Source: PubMed

3
Sottoscrivi