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.
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2014-02-03
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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
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Adult, Senior, At risk for a particular disease or infection, Client, Access to information or data, Alignment with local norms, Addressing individual beliefs and practices, Pilot, Effectiveness, Randomized, Cardiovascular disease, Chronic care, Health education or promotion, Mass messaging campaigns, Treatment adherence, Disease management, SMS, Text