Clinical InvestigationText messages for primary prevention of cardiovascular disease: The TextMe2 randomized clinical trial
Section snippets
Study design
TextMe2 was a single-site, investigator-blinded RCT with 6-month follow-up that compared SMS to standard care. Patients provided written informed consent and ethical approval was provided by the Western Sydney Local Health Network Human Research Ethics Committee. The protocol has been published elsewhere,22 and the approved and implemented study protocol (version 3.0, May 22, 2019) is available in Supplement 1. This study was conducted in an Australian tertiary referral center. Patients were
Results
Between 25 February 2019 and 22 January 2020, 295 patients were approached and 246 were recruited and randomized (mean age 58.6±10.7 years; 149 male) with 49 who were ineligible or declined. Reasons for exclusion are outlined in Figure 1. Recruitment closed when the target sample size was reached. The median time from randomization to follow-up was 6 months in both groups. Data for the primary outcome was available for 209/246 (85.0%) participants. Baseline characteristics were mostly similar
Discussion
This study assessed the utility of an SMS-based education and support program on simultaneous cardiovascular multi-risk factor control in a moderate-high risk primary prevention cohort. Although the primary outcome was not statistically significant, the secondary outcome results suggest impact of texts on risk factor control (Figure 2). This was driven by a significant reduction in physical inactivity and those with uncontrolled BP at follow-up compared to baseline. The intervention was safe,
Conclusions
Text message-support in primary prevention is feasible and has high acceptability. The primary outcome, of the between-group difference in the proportion of patients who have at least 3 uncontrolled cardiovascular risk factors at 6 months, was not significant. However, TextMe2 did motivate behavior change, reduced physical inactivity, and improved cardiovascular risk factor control overall (i.e. more intervention participants reduced the number of uncontrolled risk factors at 6-months from
Author contributions
Harry Klimis, Aravinda Thiagalingam, Clara Chow: Conceptualization, Methodology. Aravinda Thiagalingam: Software. Harry Klimis, Amy Von Huben: Formal analysis. Simone Marschner: Validation. Harry Klimis, Aravinda Thiagalingam, Daniel McIntyre: Investigation. Harry Klimis, Aravinda Thiagalingam, Amy Von Huben: Data Curation. Harry Klimis: Writing – Original Draft. All authors: Writing – Review and Editing. Harry Klimis: Visualization. Aravinda Thiagalingam, Clara Chow: Supervision. Harry Klimis:
Data availability statement
In line with the requirements of the ethics committees who approved this research, requests for access to data are to be made in writing to the corresponding author. Only de-identified participant data can be made available, along with a data dictionary and statistical code, to suitably qualified researchers who have ethical approval and have signed a data-sharing contract. The study protocol approved by ethics and the statistical analysis plan has been provided with the publication in the
Funding
HK was supported by the Royal Australian College of Physicians (RACP) Fellows Research Entry Scholarship, and the Australian Government Research Training Program (RTP) Scholarship. CKC was supported by the National Health and Medical Research Council (NHMRC) Career Development Award (APP1105447) co-funded by the National Heart Foundation, and this research was partly funded by that award. The authors are solely responsible for the design and conduct of this study, all study analyses, the
Conflict of interest
None reported.
Acknowledgments
We thank all the participants in the TextMe2 trial, and the Westmead Hospital cardiologists who staffed the rapid access cardiology clinic and supported the recruitment of patients for the TextMe2 program.
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Clinical trial registration: anzctr.org.au Identifier: ACTRN12618001153202.