Elsevier

American Heart Journal

Volume 242, December 2021, Pages 33-44
American Heart Journal

Clinical Investigation
Text messages for primary prevention of cardiovascular disease: The TextMe2 randomized clinical trial

https://doi.org/10.1016/j.ahj.2021.08.009Get rights and content

Background

Primary prevention guidelines emphasize the importance of lifestyle modification, but many at high-risk have suboptimal cardiovascular risk factor (CVRF) control. Text message support may improve control, but the evidence is sparse. Our objective was to determine the impact of text messages on multiple CVRFs in a moderate-high risk primary prevention cohort.

Methods

This study was a single-blind randomized clinical trial comparing semi-personalized text message-based support to standard care. A random sample of adults with 10-year absolute cardiovascular risk score ≥10% and without coronary heart disease, referred from February 2019 to January 2020, were recruited from an outpatient cardiology clinic in a large tertiary hospital in Sydney, Australia. Patients were randomized 1:1 to intervention or control. Intervention participants received 4 texts per week over 6 months, and standard care, with content covering: diet, physical activity, smoking, general cardiovascular health, and medication adherence. Controls received standard care only. Content was semipersonalized (smoking status, vegetarian or not-vegetarian, physical ability, taking medications or not) and delivered randomly using automated software. The primary outcome was the difference in the proportion of patients who have ≥3 uncontrolled CVRFs (out of: low-density lipoprotein cholesterol >2.0 mmol/L, blood pressure >140/90 mm Hg, body mass index ≥25 kg/m2, physical inactivity, current smoker) at 6 months adjusted for baseline. Secondary outcomes included differences in biomedical and behavioral CVRFs.

Results

Among 295 eligible participants, 246 (mean age, 58.6 ± 10.7 years; 39.4% female) were randomized to intervention (n = 124) or control (n = 122). At 6 months, there was no significant difference in the proportion of patients with ≥3 uncontrolled CVRFs (adjusted relative risk [RR] 0.98; 95% confidence interval [CI] 0.75-1.29; P = .88). Intervention participants were less likely to be physically inactive (adjusted RR 0.72; 95% CI 0.57-0.92; P = .01), but there were no significant changes in other single CVRFs. More intervention participants reduced the number of uncontrolled CVRFs at 6-months from baseline than controls (86% vs 75%; RR 1.15; 95% CI 1.00-1.32; P = .04).

Conclusions

In moderate-high cardiovascular risk primary prevention, text message-based support did not significantly reduce the proportion of patients with ≥3 uncontrolled CVRFs. However, the program did motivate behavior change and significantly improved cardiovascular risk factor control overall. Larger multicenter studies are needed.

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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