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  • Design and rationale of the Cardiovascular Health and Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study: two randomised controlled trials of text messaging to improve secondary prevention for coronary heart disease and diabetes

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Design and rationale of the Cardiovascular Health and Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study: two randomised controlled trials of text messaging to improve secondary prevention for coronary heart disease and diabetes
  1. Xiqian Huo1,
  2. Erica S Spatz2,
  3. Qinglan Ding2,
  4. Paul Horak2,
  5. Xin Zheng1,
  6. Claire Masters2,
  7. Haibo Zhang1,
  8. Melinda L Irwin2,
  9. Xiaofang Yan1,
  10. Wenchi Guan1,
  11. Jing Li1,
  12. Xi Li1,
  13. John A Spertus3,
  14. Frederick A Masoudi4,
  15. Harlan M Krumholz2,
  16. Lixin Jiang1
  1. 1 China Oxford Centre for International Health Research, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
  2. 2 Center for Outcomes Research and Evaluation, Yale University/Yale-New Haven Hospital, New Heaven, Connecticut, USA
  3. 3 Health Outcomes Research, Saint Luke’s Mid America Heart Institute/University of Missouri-Kansas City, Kansas, Missouri, USA
  4. 4 Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA
  1. Correspondence to Dr Lixin Jiang; jiangl{at}fwoxford.org

Abstract

Introduction Mobile health interventions have the potential to promote risk factor management and lifestyle modification, and are a particularly attractive approach for scaling across healthcare systems with limited resources. We are conducting two randomised trials to evaluate the efficacy of text message-based health messages in improving secondary coronary heart disease (CHD) prevention among patients with or without diabetes.

Methods and analysis The Cardiovascular Health And Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study are multicentre, single-blind, randomised controlled trials of text messaging versus standard treatment with 6 months of follow-up conducted in 37 hospitals throughout 17 provinces in China. The intervention group receives six text messages per week which target blood pressure control, medication adherence, physical activity, smoking cessation (when appropriate), glucose monitoring and lifestyle recommendations including diet (in CHAT-DM). The text messages were developed based on behavioural change techniques, using models such as the information-motivation-behavioural skills model, goal setting and provision of social support. A total sample size of 800 patients would be adequate for CHAT Study and sample size of 500 patients would be adequate for the CHAT-DM Study. In CHAT, the primary outcome is the change in systolic blood pressure (SBP) at 6 months. Secondary outcomes include a change in proportion of patients achieving a SBP <140 mm Hg, low-density lipoprotein cholesterol (LDL-C), physical activity, medication adherence, body mass index (BMI) and smoking cessation. In CHAT-DM, the primary outcome is the change in glycaemic haemoglobin (HbA1C) at 6 months. Secondary outcomes include a change in the proportion of patients achieving HbA1C<7%, fasting blood glucose, SBP, LDL-C, BMI, physical activity and medication adherence.

Ethics and dissemination The central ethics committee at the China National Center for Cardiovascular Disease and the Yale University Institutional Review Board approved the CHAT and CHAT-DM studies. Results will be disseminated via usual scientific forums including peer-reviewed publications.

Trial registration number CHAT (NCT02888769) and CHAT-DM (NCT02883842); Pre-results.

  • coronary heart disease
  • diabetes
  • text messaging
  • behavioral intervention
  • secondary prevention

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2017-018302

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    Footnotes

    • XH and ESS contributed equally.

    • Contributors XH, QD, PH, XZ, MLI, WG, JL, XL, LJ: study concept and design; XH, ESS, QD, PH, CM, XZ, HZ, XY, JAS, FAM, HMK: drafting the initial manuscript and critical revision of the paper. All authors read and approved the final manuscript.

    • Funding This project was partly supported by the Research Special Fund for Public Welfare Industry of Health (201202025, 201502009) from the National Health and Family Planning Commission of China, the National Key Technology R&D Program (2015BAI12B01, 2015BAI12B02) from the Ministry of Science and Technology of China, CAMS Innovation Fund for Medical Sciences (CIFMS 2016-I2M-2-004), and the 111 Project (B16005). ESS is supported by grant K12HS023000 from the Agency for Healthcare Research and Quality Patient-Centered Outcomes Research Institute (PCORI) mentored career development programme. The sponsors had no role in the preparation or approval of the manuscript.

    • Competing interests HMK is a recipient of research agreements from Medtronic and Johnson & Johnson (Janssen) through Yale University to develop methods of clinical trial data sharing. He is also the recipient of a grant from the Food and Drug Administration and Medtronic to develop methods for postmarket surveillance of medical devices; and is the founder of Hugo, a personal health information platform. All other authors have no conflicts of interests to declare.

    • Patient consent Obtained.

    • Ethics approval The central ethics committee at the China National Center for Cardiovascular Disease (NCCD) and the Yale University Institutional Review Board approved the CHAT and CHAT-DM studies. All collaborating hospitals accepted the central ethics approval except for 8, which obtained local approval by internal ethics committees.

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