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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.

ABSTRACT: 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.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.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.NCT02019823.

SUBMITTER: Bobrow K

PROVIDER: S-EPMC3909351 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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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.

Bobrow Kirsty K Brennan Thomas T Springer David D Levitt Naomi S NS Rayner Brian B Namane Mosedi M Yu Ly-Mee LM Tarassenko Lionel L Farmer Andrew A

BMC public health 20140111

<h4>Background</h4>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 ...[more]

PMID: 24410738

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Project description:BackgroundWe assessed the effect of automated treatment adherence support delivered via mobile phone short message system (SMS) text messages on blood pressure.Methods and resultsIn this pragmatic, single-blind, 3-arm, randomized trial (SMS-Text Adherence Support [StAR]) undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information only, interactive SMS text messaging, or usual care. The primary outcome was change in systolic blood pressure at 12 months from baseline measured with a validated oscillometric device. All trial staff were masked to treatment allocation. Analyses were intention to treat. Between June 26, 2012, and November 23, 2012, 1372 participants were randomized to receive information-only SMS text messages (n=457), interactive SMS text messages (n=458), or usual care (n=457). Primary outcome data were available for 1256 participants (92%). At 12 months, the mean adjusted change in systolic blood pressure compared with usual care was -2.2 mm Hg (95% confidence interval, -4.4 to -0.04) with information-only SMS and -1.6 mm Hg (95% confidence interval, -3.7 to 0.6) with interactive SMS. Odds ratios for the proportion of participants with a blood pressure <140/90 mm Hg were 1.42 (95% confidence interval, 1.03-1.95) for information-only messaging and 1.41 (95% confidence interval, 1.02-1.95) for interactive messaging compared with usual care.ConclusionsIn this randomized trial of an automated adherence support program delivered by SMS text message in a general outpatient population of adults with high blood pressure, we found a small reduction in systolic blood pressure control compared with usual care at 12 months. There was no evidence that an interactive intervention increased this effect.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT02019823. South African National Clinical Trials Register, number SANCTR DOH-27-1212-386; Pan Africa Trial Register, number PACTR201411000724141.

Project description:BackgroundEffective use of proven treatments for high blood pressure, a preventable health risk, is challenging for many patients. Prompts via mobile phone SMS-text messaging may improve adherence to clinic visits and treatment, though more research is needed on impact and patient perceptions of such support interventions, especially in low-resource settings.MethodAn individually-randomised controlled trial in a primary care clinic in Cape Town (2012-14), tested the effect of an adherence support intervention delivered via SMS-texts, on blood pressure control and adherence to medication, for hypertensive patients. (Trial registrationClinicalTrials.gov NCT02019823). We report on a qualitative evaluation that explored the trial participants' experiences and responses to the SMS-text messages, and identified barriers and facilitators to delivering adherence support via patients' own mobile phones. Two focus groups and fifteen individual interviews were conducted. We used comparative and thematic analysis approaches to identify themes and triangulated our analysis amongst three researchers.ResultsMost participants were comfortable with the technology of using SMS-text messages. Messages were experienced as acceptable, relevant and useful to a broad range of participants. The SMS-content, the respectful tone and the delivery (timing of reminders and frequency) and the relational aspect of trial participation (feeling cared for) were all highly valued. A subgroup who benefitted the most, were those who had been struggling with adherence due to high levels of personal stress. The intervention appeared to coincide with their readiness for change, and provided practical and emotional support for improving adherence behaviour. Change may have been facilitated through increased acknowledgement of their health status and attitudinal change towards greater self-responsibility. Complex interaction of psycho-social stressors and health service problems were reported as broader challenges to adherence behaviours.ConclusionAdherence support for treatment of raised blood pressure, delivered via SMS-text message on the patient's own phone, was found to be acceptable, relevant and helpful, even for those who already had their own reminder systems in place. Our findings begin to identify for whom and what core elements of the SMS-text message intervention appear to work best in a low-resource operational setting, issues that future research should explore in greater depth.

Project description:Millions of smokers use the Internet for smoking cessation assistance each year; however, most smokers engage minimally with even the best designed websites. The ubiquity of mobile devices and their effectiveness in promoting adherence in other areas of health behaviour change make them a promising tool to address adherence in Internet smoking cessation interventions. Text messaging is used by most adults, and messages can proactively encourage use of a web-based intervention. Text messaging can also be integrated with an Internet intervention to facilitate the use of core Internet intervention components.We identified four aspects of a text message intervention that may enhance its effectiveness in promoting adherence to a web-based smoking cessation programme: personalisation, integration, dynamic tailoring and message intensity. Phase I will use a two-level full factorial design to test the impact of these four experimental features on adherence to a web-based intervention. The primary outcome is a composite metric of adherence that incorporates general utilisation metrics (eg, logins, page views) and specific feature utilisation shown to predict abstinence. Participants will be N=860 adult smokers who register on an established Internet cessation programme and enrol in its text message programme. Phase II will be a two-arm randomised trial to compare the efficacy of the web-based cessation programme alone and in conjunction with the optimised text messaging intervention on 30-day point prevalence abstinence at 9 months. Phase II participants will be N=600 adult smokers who register to use an established Internet cessation programme and enrol in text messaging. Secondary analyses will explore whether adherence mediates the effect of treatment condition on outcome.This protocol was approved by Chesapeake IRB. We will disseminate study results through peer-reviewed manuscripts and conference presentations related to the methods and design, outcomes and exploratory analyses.NCT02585206.

Project description:BackgroundeHealth interventions can help people change behavior (eg, quit smoking). Reminders sent via SMS text messaging or email may improve the adherence to web-based programs and increase the probability of successful behavior change; however, it is unclear whether their efficiency is affected by the modality of the communication channel.ObjectiveA 2-armed randomized control trial was conducted to compare the effect of providing reminders via SMS text messaging versus email on the adherence to an eHealth program for smoking cessation and on the probability to initiate a quit attempt.MethodsSmokers were recruited via an internet-based advertisement. A total of 591 participants who diverted from intended use of the program (ie, failed to log on to a session) were automatically randomized to the experimental (SMS text messaging reminder, n=304) or the active comparator (email reminder, n=287) group.ResultsUnexpectedly, we found that the mode of reminder delivery did not significantly affect either the adherence, namely the number of completed program sessions, with the SMS text messaging reminder group showing a mean of 4.30 (SD 3.24) and the email reminder group showing a mean of 4.36 (SD 3.27) (t586=0.197, P=.84, and Cohen d=0.016), or the outcome, namely the quit smoking attempt rate (34.2% in the SMS text messaging group vs 31.7% in the email group; χ21=0.4, P=.52). Secondary analyses showed that age, gender, and education had significant effects on program adherence and education on the outcome. Moreover, we found a significant interaction effect between the mode of reminder delivery and gender on program adherence, suggesting that the effectiveness of SMS text message reminders might be different for females and males. However, this particular finding should be treated with care as it was based on post hoc subgroup analysis.ConclusionsThis study indicates that the modality of user reminders to log on increased neither the program adherence nor the probability of quitting smoking. This suggests that program developers may save costs using emails instead of SMS text messaging reminders.Trial registrationClinicalTrials.gov NCT03276767; https://clinicaltrials.gov/ct2/show/ NCT03276767.

Project description:BackgroundClinic attendance, metabolic control, engagement in self-management, and psychological health are suboptimal in young-onset (age of onset <40 years) type 2 diabetes.ObjectiveWe examined the effectiveness of an enhanced SMS text message-based support and reminder program in improving clinic attendance, metabolic control, engagement in self-management, and psychological health in young-onset type 2 diabetes.MethodsA 12-month, parallel-arm, randomized controlled trial comparing an enhanced, semipersonalized SMS text message-based intervention (incorporating 1-8 supportive and/or informative text messages per month) against standard care was conducted in a specialized clinic for young adult type 2 diabetes. The primary outcome was maintenance of 100% attendance at scheduled quarterly clinical appointments. Secondary outcomes included (1) metabolic indices, (2) pathology and self-monitored blood glucose (SMBG) data availability, and (3) psychosocial well-being.ResultsA total of 40 participants were randomized, and 32 completed their 12-month study visit. The average participant age was 32.7 (SD 5.1) years, 50% (20/40) were male, and baseline glycated hemoglobin A1c (HbA1c) was 7.3% (SD 1.9%) (56 mmol/mol, SD 20). A higher proportion of the intervention group achieved 100% attendance (12/21, 57%, vs 5/19, 26%, for the control group); Kaplan-Meier analysis demonstrated significantly greater cumulative attendance in the intervention group (P=.04). There were no between-group differences in HbA1c, BMI, lipids, or availability of pathology and SMBG data. Odds of recording an improvement in the Diabetes Empowerment Scale-Short Form score were higher in the intervention group at 6 months (odds ratio [OR] 4.3, 95% CI 1.1-17), with attenuation of this effect at study end (OR 3.1, 95% CI 0.9-11). Program acceptability was high; >90% of participants would recommend the program to new patients.ConclusionsAn enhanced SMS text message-based support and reminder program doubled scheduled clinic attendance rates for patients with young-onset type 2 diabetes. The program was highly acceptable and provided early support for patient empowerment but had no significant effect on measures of metabolic control or self-management.Trial registrationAustralian and New Zealand Clinical Trials Registry (ACTRN12618000479202); https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373579.

Dataset Information

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.

Publications

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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