Text2PreventCVD: protocol for a systematic review and individual participant data meta-analysis of text message-based interventions for the prevention of cardiovascular diseases

Introduction Text message interventions have been shown to be effective in prevention and management of several non-communicable disease risk factors. However, the extent to which their effects might vary in different participants and settings is uncertain. We aim to conduct a systematic review and individual participant data (IPD) meta-analysis of randomised clinical trials examining text message interventions aimed to prevent cardiovascular diseases (CVD) through modification of cardiovascular risk factors (CVRFs). Methods and analysis Systematic review and IPD meta-analysis will be conducted according to Preferred Reporting Items for Systematic review and Meta-Analysis of IPD (PRISMA-IPD) guidelines. Electronic database of published studies (MEDLINE, EMBASE, PsycINFO and Cochrane Library) and international trial registries will be searched to identify relevant randomised clinical trials. Authors of studies meeting the inclusion criteria will be invited to join the IPD meta-analysis group and contribute study data to the common database. The primary outcome will be the difference between intervention and control groups in blood pressure at 6-month follow-up. Key secondary outcomes include effects on lipid parameters, body mass index, smoking levels and self-reported quality of life. If sufficient data is available, we will also analyse blood pressure and other secondary outcomes at 12 months. IPD meta-analysis will be performed using a one-step approach and modelling data simultaneously while accounting for the clustering of the participants within studies. This study will use the existing data to assess the effectiveness of text message-based interventions on CVRFs, the consistency of any effects by participant subgroups and across different healthcare settings. Ethics and dissemination Ethical approval was obtained for the individual studies by the trial investigators from relevant local ethics committees. This study will include anonymised data for secondary analysis and investigators will be asked to check that this is consistent with their existing approvals. Results will be disseminated via scientific forums including peer-reviewed publications and presentations at international conferences. Trial registration number CRD42016033236.

[1]  Sheikh Mohammed Shariful Islam,et al.  mHealth in Cardiovascular Health Care. , 2016, Heart, lung & circulation.

[2]  P. Shekelle,et al.  Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation , 2016, British Medical Journal.

[3]  Lionel Tarassenko,et al.  Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (SMS-Text Adherence Support [StAR]): A Single-Blind, Randomized Trial , 2016, Circulation.

[4]  Ralph Maddison,et al.  Text Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial , 2015, Journal of medical Internet research.

[5]  G. Hillis,et al.  Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification in Patients With Coronary Heart Disease: A Randomized Clinical Trial. , 2015, JAMA.

[6]  C. Montag,et al.  Smartphone usage in the 21st century: who is active on WhatsApp? , 2015, BMC Research Notes.

[7]  Andreas Lechner,et al.  Effects of Mobile Phone SMS to Improve Glycemic Control Among Patients With Type 2 Diabetes in Bangladesh: A Prospective, Parallel-Group, Randomized Controlled Trial , 2015, Diabetes Care.

[8]  Julie Redfern,et al.  The mobile revolution—using smartphone apps to prevent cardiovascular disease , 2015, Nature Reviews Cardiology.

[9]  C. Chow,et al.  Strengthening preventive cardiology. , 2015, Heart, lung & circulation.

[10]  Richard D Riley,et al.  Preferred Reporting Items for a Systematic Review and Meta-analysis of Individual Participant Data: The PRISMA-IPD Statement , 2015 .

[11]  P. Shekelle,et al.  Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation , 2015, BMJ : British Medical Journal.

[12]  R. Holle,et al.  Mobile phone intervention for increasing adherence to treatment for type 2 diabetes in an urban area of Bangladesh: protocol for a randomized controlled trial , 2014, BMC Health Services Research.

[13]  R. Sacco,et al.  Sustainable Development Goals and the Future of Cardiovascular Health: A Statement From the Global Cardiovascular Disease Taskforce , 2014, Journal of the American Heart Association.

[14]  C. O'connor,et al.  Exercise training for chronic heart failure (ExTraMATCH II): protocol for an individual participant data meta-analysis. , 2014, International journal of cardiology.

[15]  J Redfern,et al.  Development of a set of mobile phone text messages designed for prevention of recurrent cardiovascular events , 2014, European journal of preventive cardiology.

[16]  Ralph Maddison,et al.  Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol , 2014, Trials.

[17]  Lionel Tarassenko,et al.  Efficacy of a text messaging (SMS) based intervention for adults with hypertension: protocol for the StAR (SMS Text-message Adherence suppoRt trial) randomised controlled trial , 2014, BMC Public Health.

[18]  L. Neubeck,et al.  A randomised controlled trial of a consumer-focused e-health strategy for cardiovascular risk management in primary care: the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) study protocol , 2014, BMJ Open.

[19]  D. Prabhakaran,et al.  Prospective meta-analysis of trials comparing fixed dose combination based care with usual care in individuals at high cardiovascular risk: the SPACE Collaboration. , 2013, International journal of cardiology.

[20]  Lawrence Mbuagbaw,et al.  Mobile phone text messages for improving adherence to antiretroviral therapy (ART): an individual patient data meta-analysis of randomised trials , 2013, BMJ Open.

[21]  A. Haines,et al.  The Effectiveness of Mobile-Health Technology-Based Health Behaviour Change or Disease Management Interventions for Health Care Consumers: A Systematic Review , 2013, PLoS medicine.

[22]  G. Hillis,et al.  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 , 2012, BMJ Open.

[23]  A. Sutton,et al.  Assessment of publication bias, selection bias, and unavailable data in meta-analyses using individual participant data: a database survey , 2012, BMJ : British Medical Journal.

[24]  Ralph Maddison,et al.  HEART: heart exercise and remote technologies: A randomized controlled trial study protocol , 2011, BMC cardiovascular disorders.

[25]  W. Jack,et al.  Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial , 2010, The Lancet.

[26]  Richard Emsley,et al.  Ian R White interventions Mediation and moderation of treatment effects in randomised controlled trials of complex , 2010 .

[27]  R. Riley,et al.  Meta-analysis of individual participant data: rationale, conduct, and reporting , 2010, BMJ : British Medical Journal.

[28]  J. Feder,et al.  Cell-phone medicine brings care to patients in developing nations. , 2010, Health affairs.

[29]  W. Kraus,et al.  Method for Establishing Authorship in a Multicenter Clinical Trial , 2009, Annals of Internal Medicine.

[30]  Susan Michie,et al.  Designing and implementing behaviour change interventions to improve population health , 2008, Journal of health services research & policy.

[31]  Mark C Simmonds,et al.  Meta-analysis of individual patient data from randomized trials: a review of methods used in practice , 2005, Clinical trials.

[32]  M. Piepoli,et al.  Exercise training meta-analysis of trials in patients with chronic heart failure (ExTraMATCH) , 2004, BMJ : British Medical Journal.

[33]  F. Turnbull Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomised trials , 2003, The Lancet.

[34]  L. Stewart,et al.  To IPD or not to IPD? , 2002, Evaluation & the health professions.

[35]  M. Buyse,et al.  Surrogate threshold effect: an alternative measure for meta-analytic surrogate endpoint validation. , 2006, Pharmaceutical statistics.