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Epidemiology
Protocol
Text2PreventCVD: protocol for a systematic review and individual participant data meta-analysis of text message-based interventions for the prevention of cardiovascular diseases
  1. Clara K Chow1,2,
  2. Sheikh Mohammed Shariful Islam1,2,3,
  3. Andrew Farmer4,
  4. Kirsty Bobrow4,5,
  5. Ralph Maddision6,7,
  6. Robyn Whittaker6,
  7. Leila Pfaeffli Dale6,
  8. Andreas Lechner8,
  9. Louis Niessen9,10,
  10. Scott A Lear11,
  11. Zubin J Eapen12,
  12. Karla Santo1,2,
  13. Sandrine Stepien1,
  14. Julie Redfern1,2,
  15. Anthony Rodgers1,2
    1. 1The George Institute for Global Health, Sydney, Australia
    2. 2Sydney Medical School, University of Sydney, Sydney, Australia
    3. 3Ludwig-Maximillian Universitat, Munich, Germany
    4. 4Oxford University, Oxford, UK
    5. 5University of Cape Town, South Africa
    6. 6The University of Auckland, Auckland, New Zealand
    7. 7Deakin University, Melbourne, Australia
    8. 8Diabetes Research Group, Ludwig—Maximilians University, Munich, Germany
    9. 9Liverpool School of Tropical Medicine, Liverpool, UK
    10. 10Johns Hopkins University, Baltimore, Maryland, USA
    11. 11Simon Fraser University and St. Paul's Hospital, Vancouver, British Columbia, Canada
    12. 12Duke Clinical Research Institute, Durham, North Carolina, USA
    1. Correspondence to Professor Clara K Chow; cchow{at}georgeinstitute.org.au

    Abstract

    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.

    • Cardiovascular diseases
    • prevention
    • text messages
    • randomized controlled trials
    • short message service (SMS)

    This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

    https://doi.org/10.1136/bmjopen-2016-012723

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      Footnotes

      • Twitter Follow Sheikh Mohammed Shariful Islam at @drsislam

      • Collaborators Text2PreventCVD trial collaborator group: (1) Cardiovascular Division, The George Institute for Global Health, Sydney, Australia (secretariat): Clara Chow, Julie Redfern, Anthony Rodgers, Shariful Islam, Aravinda Thiagalingam (TEXT ME trial9 ,29). (2) University of Oxford, Institute of Biomedical Engineering, Oxford, UK/Chronic Disease Initiative for Africa, Division of Diabetes and Endocrinology, Department of Medicine, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa South Africa: Kirsty Bobrow, Andrew Farmer (StAR-BP30 ,31). (3) Center for International Health, Ludwig-Maximilians University, Munich, Germany/Liverpool School of Tropical Medicine, UK, and Center for Control of Chronic Diseases, ICDDR,B, Dhaka, Bangladesh: Louis Niessen and Shariful Islam (MPID trial32 ,33). (4) Diabetes Research Group, Medizinische Klinik 4, Klinikum der Universitaet Muenchen, Ludwig-Maximilians University, Munich, Germany: Andreas Lechner. (5) National Institute for Health Innovation, The University of Auckland, New Zealand: Robyn Whittaker, Ralph Maddision and Leila Pfaeffli Dale (HEART34 and Text4Heart35 ,36). (6) Simon Fraser University and St. Paul's Hospital, Vancouver, BC, Canada: Scott Lear. (6) Duke University, USA: Zubin Eapen.

      • Contributors  CKC, SMSI, JR and AR contributed to the study concept and design. CKC and SMSI participated in the drafting of the manuscript. All the authors were involved in the critical revision of the manuscript for important intellectual content.

      • Funding The George Institute funded the secretariat. SMSI is funded by the George Institute for Global Health Post Doctorate Research Fellowship. AF is an NIHR senior investigator and received support from NIHR Oxford Biomedical Research Centre. CKC is funded by a Career Development Fellowship cofunded by the National Health and Medical Research Council (NHMRC) and National Heart Foundation and Sydney Medical Foundation Chapman Fellowship. JR is funded by an NHMRC Career Development Fellowship cofunded with a National Heart Foundation Future Fellowship. AR has a NHMRC Principal Fellowship.

      • Competing interests None declared.

      • Provenance and peer review Not commissioned; externally peer reviewed.