Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2014 Jan 11:14:28.
doi: 10.1186/1471-2458-14-28.

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

Affiliations
Randomized Controlled Trial

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

Kirsty Bobrow et al. BMC Public Health. .

Abstract

Background: Interventions to support people with hypertension in attending clinics and taking their medication have potential to improve outcomes, but delivery on a wide scale and at low cost is challenging. Some trials evaluating clinical interventions using short message service (SMS) text-messaging systems have shown important outcomes, although evidence is limited. We have developed a novel SMS system integrated with clinical care for use by people with hypertension in a low-resource setting. We aim to test the efficacy of the system in improving blood pressure control and treatment adherence compared to usual care.

Methods/design: The SMS Text-message Adherence suppoRt trial (StAR) is a pragmatic individually randomised three-arm parallel group trial in adults treated for hypertension at a single primary care centre in Cape Town, South Africa. The intervention is a structured programme of clinic appointment, medication pick-up reminders, medication adherence support and hypertension-related education delivered remotely using an automated system with either informational or interactive SMS text-messages. Usual care is supplemented by infrequent non-hypertension related SMS text-messages. Participants are 1:1:1 individually randomised, to usual care or to one of the two active interventions using minimisation to dynamically adjust for gender, age, baseline systolic blood pressure, years with hypertension, and previous clinic attendance. The primary outcome is the change in mean systolic blood pressure at 12-month follow-up from baseline measured with research staff blinded to trial allocation. Secondary outcomes include the proportion of patients with 80% or more of days medication available, proportion of participants achieving a systolic blood pressure less than 140 mmHg and a diastolic blood pressure less than 90 mmHg, hospital admissions, health status, retention in clinical care, satisfaction with treatment and care, and patient related quality of life. Anonymised demographic data are collected on non-participants.

Discussion: The StAR trial uses a novel, low cost system based on widely available mobile phone technology to deliver the SMS-based intervention, manage communication with patients, and measure clinically relevant outcomes. The results will inform implementation and wider use of mobile phone based interventions for health care delivery in a low-resource setting.

Trial registration: NCT02019823.

PubMed Disclaimer

Figures

Figure 1
Figure 1
CONSORT diagram for SMS-text Adherence suppoRt Trial (StAR).
Figure 2
Figure 2
Process of intervention development adapted from Smith et al. [[18]].

References

    1. Lawes CMM, Vander Hoorn S, Rodgers A. et al.Global burden of blood-pressure-related disease, 2001. Lancet. 2008;371:1513–1518. doi: 10.1016/S0140-6736(08)60655-8. - DOI - PubMed
    1. Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H. et al.A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990–2010: a systematic analysis for the global burden of disease study 2010. Lancet. 2012;380:2224–2260. doi: 10.1016/S0140-6736(12)61766-8. 1. - DOI - PMC - PubMed
    1. Lewington S, Clarke R, Qizilbash N. et al.Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002;360:1903–1913. - PubMed
    1. Collins R, Peto R, MacMahon S. et al.Blood pressure, stroke, and coronary heart disease. Part 2. Lancet. 1990;335:827–838. doi: 10.1016/0140-6736(90)90944-Z. - DOI - PubMed
    1. Staessen JAJ, Wang JGJ, Thijs LL. Cardiovascular protection and blood pressure reduction: a meta-analysis. Lancet. 2001;358:1305–1315. doi: 10.1016/S0140-6736(01)06411-X. - DOI - PubMed

Publication types

Associated data