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A randomized clinical trial of an interactive voice response and text message intervention for individuals with hypertension.

ABSTRACT: Interactive voice response and text message (IVR-T) technology may improve hypertension control in under-resourced settings. We conducted a randomized clinical trial to determine whether an IVR-T intervention would improve blood pressure (BP), medication adherence and visit keeping among adults with hypertension from multiple racial and ethnic groups in primary care at an Urban Indian Health Organization in Albuquerque, New Mexico. Two hundred and ninety-five participants were randomly assigned to IVR-T (N = 148) or to usual care (N = 147). The IVR-T arm received reminders for clinic visits, messages to reschedule missed clinic visits, monthly medication refill reminders, weekly motivational messages, and a blood pressure cuff. The usual care arm received no messages. The primary outcome was change in systolic BP (SBP) between baseline and 12 months. Secondary outcomes included change in SBP between baseline and 6 months, change in diastolic BP (DBP) at 6 and 12 months, self-reported adherence at 6 months, and the proportion of missed primary care clinic appointments. The intervention did not affect SBP or DBP at 6 or 12 months. The 12-month change in SBP/DBP was 1.66/1.10 mm Hg in usual care and 0.23/1.34 mm Hg in the intervention group (P values = .57 and .88, respectively). Self-reported medication adherence improved comparably in both groups, and there was no difference in percentage of kept visits. Several features of study design, clinic operations, and data transfer were barriers to demonstrating effectiveness.

SUBMITTER: Schroeder EB

PROVIDER: S-EPMC8029814 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Efficient and effective strategies for treating chronic health conditions such as hypertension are particularly needed for under-resourced clinics such as Urban Indian Health Organizations (UIHOs). OBJECTIVE:The objective of the Controlling Blood Pressure Trial is to assess the impact of an interactive voice response and text message (IVR-T) intervention compared with usual care among individuals with hypertension receiving care at a UIHO in Albuquerque, New Mexico. This manuscript presents the baseline characteristics of individuals enrolled in the trial and compares their characteristics with those in the hypertension registry who did not enroll in the trial. METHODS:A hypertension registry developed from the clinic's electronic health record was used for recruitment. Potentially eligible participants were contacted by letter and then by phone. Those who expressed interest completed an in-person baseline visit that included a baseline survey and blood pressure measurement using standardized procedures. Individuals randomized to the intervention group could opt to receive either automated text messages or automated phone calls in either English or Spanish. The messages include reminders of upcoming appointments at First Nations Community HealthSource, requests to reschedule recently missed appointments, monthly reminders to refill medications, and weekly motivational messages to encourage self-care, appointment keeping, and medication taking for hypertension. Individuals in the IVR-T arm could opt to nominate a care partner to also receive notices of upcoming and missed appointments. Individuals in the IVR-T arm were also offered a home blood pressure monitor. Follow-up visits will be conducted at 6 months and 12 months. RESULTS:Over a 9.5-month period from April 2017 to January 2018, 295 participants were enrolled from a recruitment list of 1497 individuals. The enrolled cohort had a mean age of 53 years, was 25.1% (74/295) American Indian or Alaska Native and 51.9% (153/295) Hispanic, and 39.0% (115/295) had a baseline blood pressure greater than or equal to 140/90 mmHg. Overall, the differences between those enrolled in the trial and patients with hypertension who were ineligible, those who could not be reached, or those who chose not to enroll were minimal. Enrolled individuals had a slightly lower blood pressure (129/77 mmHg vs 132/79 mmHg; P=.04 for systolic blood pressure and P=.01 for diastolic blood pressure), were more likely to self-pay for their care (26% vs 10%; P<.001), and had a more recent primary care visit (164 days vs 231 days; P<.001). The enrolled cohort reported a high prevalence of poor health, low socioeconomic status, and high levels of basic material needs. CONCLUSIONS:The Controlling Blood Pressure Trial has successfully enrolled a representative sample of individuals receiving health care at a UIHO. Trial follow-up will conclude in February 2019. TRIAL REGISTRATION:ClinicalTrials.gov NCT03135405; http://clinicaltrials.gov/ct2/show/NCT03135405 (Archived by WebCite http://www.webcitation.org/76H2B4SO6). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11794.

Project description:ObjectiveTo evaluate the feasibility of a randomized controlled pilot study with lifestyle-promoting text messages as a treatment for hypertension in primary care.DesignRandomized controlled pilot trial.SettingThree primary health care centers in southern Sweden.SubjectsSixty patients aged 40-80 years with hypertension were included.Main outcome measuresFeasibility of the pilot study, i.e. recruitment rate, dropout rate and eligibility criteria. Secondary outcomes were change in blood pressure and other cardiovascular risk factors.MethodsThirty participants were randomized to the intervention group with four lifestyle-promoting text messages sent every week for six months. The control group received usual care. The baseline and follow-up visits for all 60 patients included measurements of blood pressure, anthropometrics, blood tests and a self-reported questionnaire.ResultsAll feasibility criteria (recruitment rate (≥55%), dropout rate (≤15%) and eligibility (60 eligible patients during the four-month inclusion period) for the pilot study were fulfilled. This means that a larger study with a similar design may be conducted. After six months, there were no significant improvements in cardiovascular risk factors. However, we found favorable trends for all secondary outcomes in the intervention group as compared to the control group.ConclusionLifestyle modification in patients with hypertension is important to reduce cardiovascular risk. However, primary healthcare has limited resources to work with modifying lifestyle habits. This is the first pilot study to test the feasibility of text message-based lifestyle intervention in patients with hypertension in Swedish primary healthcare. Whether significant improvement in cardiovascular risk factors may be achieved in a larger study population remains to be evaluated. Key points This pilot randomized controlled trial (RCT) is the first study to evaluate the feasibility of text message-based lifestyle advice to patients with hypertension in Swedish primary healthcare. •All feasibility criteria for the pilot study were fulfilled. This outcome means that a larger study with a similar design may be conducted. •The study was not powered to find significant changes in cardiovascular risk factors. Nevertheless, after six months we found favorable trends for all secondary outcomes in the intervention group compared to control. •If a future larger study can show significant results, this intervention could serve as a useful tool in everyday primary healthcare.

Project description:Binge drinking is associated with numerous negative consequences. The prevalence and intensity of binge drinking is highest among young adults. This randomized trial tested the efficacy of a 12-week interactive text message intervention to reduce binge drinking up to 6 months after intervention completion among young adults.Young adult participants (18-25 y; n = 765) drinking above the low-risk limits (AUDIT-C score >3/4 women/men), but not seeking alcohol treatment, were enrolled from 4 Emergency Departments (EDs) in Pittsburgh, PA. Participants were randomized to one of three conditions in a 2:1:1 allocation ratio: SMS Assessments + Feedback (SA+F), SMS Assessments (SA), or control. For 12 weeks, SA+F participants received texts each Thursday querying weekend drinking plans and prompting drinking limit goal commitment and each Sunday querying weekend drinking quantity. SA+F participants received tailored feedback based on their text responses. To contrast the effects of SA+F with self-monitoring, SA participants received texts on Sundays querying drinking quantity, but did not receive alcohol-specific feedback. The control arm received standard care. Follow-up outcome data collected through web-based surveys were provided by 78% of participants at 3- months, 63% at 6-months and 55% at 9-months. Multiple imputation-derived, intent-to-treat models were used for primary analysis. At 9-months, participants in the SA+F group reported greater reductions in the number of binge drinking days than participants in the control group (incident rate ratio [IRR] 0.69; 95% CI .59 to.79), lower binge drinking prevalence (odds ratio [OR] 0.52; 95% CI 0.26 to 0.98]), less drinks per drinking day (beta -.62; 95% CI -1.10 to -0.15) and lower alcohol-related injury prevalence (OR 0.42; 95% CI 0.21 to 0.88). Participants in the SA group did not reduce drinking or alcohol-related injury relative to controls. Findings were similar using complete case analyses.An interactive text-message intervention was more effective than self-monitoring or controls in reducing alcohol consumption and alcohol-related injury prevalence up to 6 months after intervention completion. These findings, if replicated, suggest a scalable approach to help achieve sustained reductions in binge drinking and accompanying injuries among young adults.ClinicalTrials.gov NCT01688245.

Project description:Study objectiveOpportunistic brief in-person emergency department (ED) interventions can be effective at reducing hazardous alcohol use in young adult drinkers, but require resources frequently unavailable. Mobile telephone text messaging (short message service [SMS]) could sustainably deliver behavioral support to young adult patients, but efficacy remains unknown. We report 3-month outcome data of a randomized controlled trial testing a novel SMS-delivered intervention in hazardous-drinking young adults.MethodsWe randomized 765 young adult ED patients who screened positive for past hazardous alcohol use to one of 3 groups: SMS assessments+feedback (SA+F) intervention who were asked to respond to drinking-related queries and received real-time feedback through SMS each Thursday and Sunday for 12 weeks (n=384), SMS assessments (SA) who were asked to respond to alcohol consumption queries each Sunday but did not receive any feedback (N=196), and a control group who did not participate in any SMS (n=185). Primary outcomes were self-reported number of binge drinking days and number of drinks per drinking day in the past 30 days, collected by Web-based timeline follow-back method and analyzed with regression models. Secondary outcomes were the proportion of participants with weekend binge episodes and most drinks consumed per drinking occasion during 12 weekends, collected by SMS.ResultsWith Web-based data, there were decreases in the number of self-reported binge drinking days from baseline to 3 months in the SA+F group (-0.51 [95% confidence interval {CI} -0.10 to -0.95]), whereas there were increases in the SA group (0.90 [95% CI 0.23 to 1.6]) and the control group (0.41 [95% CI -0.20 to 1.0]). There were also decreases in the number of self-reported drinks per drinking day from baseline to 3 months in the SA+F group (-0.31 [95% CI -0.07 to -0.55]), whereas there were increases in the SA group (0.10 [95% CI -0.27 to 0.47]) and the control group (0.39 [95% CI 0.06 to 0.72]). With SMS data, there was a lower mean proportion of SA+F participants reporting a weekend binge during 12 weeks (30.5% [95% CI 25% to 36%) compared with the SA participants (47.7% [95% CI 40% to 56%]). There was also a lower mean drinks consumed per weekend during 12 weeks in the SA+F group (3.2 [95% CI 2.6 to 3.7]) compared to the SA group (4.8 [95% CI 4.0 to 5.6]).ConclusionA text message intervention can produce small reductions in self-reported binge drinking and the number of drinks consumed per drinking day in hazardous-drinking young adults after ED discharge.

Project description:BackgroundMobile technology offers the potential to deliver health-related interventions to individuals who would not otherwise present for in-person treatment. Text messaging (short message service, SMS), being the most ubiquitous form of mobile communication, is a promising method for reaching the most individuals.ObjectiveThe goal of the present study was to evaluate the feasibility and preliminary efficacy of a smoking cessation intervention program delivered through text messaging.MethodsAdult participants (N=60, age range 18-52 years) took part in a single individual smoking cessation counseling session, and were then randomly assigned to receive either daily non-smoking related text messages (control condition) or the TXT-2-Quit (TXT) intervention. TXT consisted of automated smoking cessation messages tailored to individual's stage of smoking cessation, specialized messages provided on-demand based on user requests for additional support, and a peer-to-peer social support network. Generalized estimating equation analysis was used to assess the primary outcome (7-day point-prevalence abstinence) using a 2 (treatment groups)×3 (time points) repeated measures design across three time points: 8 weeks, 3 months, and 6 months.ResultsSmoking cessation results showed an overall significant group difference in 7-day point prevalence abstinence across all follow-up time points. Individuals given the TXT intervention, with higher odds of 7-day point prevalence abstinence for the TXT group compared to the Mojo group (OR=4.52, 95% CI=1.24, 16.53). However, individual comparisons at each time point did not show significant between-group differences, likely due to reduced statistical power. Intervention feasibility was greatly improved by switching from traditional face-to-face recruitment methods (4.7% yield) to an online/remote strategy (41.7% yield).ConclusionsAlthough this study was designed to develop and provide initial testing of the TXT-2-Quit system, these initial findings provide promising evidence that a text-based intervention can be successfully implemented with a diverse group of adult smokers.Trial registrationClinicalTrials.gov: NCT01166464; http://clinicaltrials.gov/ct2/show/NCT01166464 (Archived by WebCite at http://www.webcitation.org/6IOE8XdE0).

Project description: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.

Project description:AimsTo evaluate the effectiveness of a combined internet and text message intervention for smoking cessation compared with an internet intervention alone. The text message intervention was optimized for engagement in an earlier multiphase optimization (MOST) screening phase.DesignA parallel, two-group, individually randomized clinical trial (RCT) was conducted in a MOST confirming phase. Recruitment spanned December 2018 to March 2019. Follow-up was conducted at 3 and 9 months, beginning March 2019 and ending January 2020.SettingUnited States: a digital study conducted among new registrants on a free tobacco cessation website.ParticipantsEligible individuals were 618 adult current smokers in the United States, age 18 years or older who signed up for text messages during website registration (67.2% female, 70.4% white).InterventionsThe treatment arm (WEB+TXT; n = 311) received access to the website and text messaging. The control arm (WEB; n = 307) received access to the website alone.MeasurementsThe primary outcome was self-reported 30-day point prevalence abstinence (ppa) at 9 months post-randomization analyzed under intent to treat (ITT), counting non-responders as smoking. Secondary outcomes included 3-month measures of 30-day ppa, intervention engagement and intervention satisfaction.FindingsAbstinence rates at 9 months were 23.1% among WEB+TXT and 23.2% among WEB (OR = 1.00, 95% CI = 0.69-1.45; P = 0.99). WEB+TXT increased engagement with 5 of 6 interactive features (standardized mean difference (SMD) = 0.26-0.47, all P < 0.001) and repeat website visits (48.7% vs 38.9%, SMD = 0.14, P = 0.02). Satisfaction metrics favored WEB+TXT (satisfied: 96.3% vs 90.5%, SMD = 0.17, P = 0.008; recommend to friend: 95.9% vs 90.1%, SMD = 0.16, P = 0.028).ConclusionsA randomized controlled trial found no evidence that a combined internet and text message intervention for smoking cessation compared with an internet intervention alone increased 9-month abstinence rates among adult current smokers in the United States, despite evidence of higher levels of intervention engagement and satisfaction at 3 months.

Project description:Smoking is globally the most important preventable cause of ill health and death. Mobile telephone interventions and, in particular, short message service (SMS) text messaging, have the potential to overcome access barriers to traditional health services, not least among young people.To determine the effectiveness of a text-based smoking cessation intervention among young people.A single-blind, 2-arm, randomized clinical trial (Nicotine Exit [NEXit]) was conducted from October 23, 2014, to April 17, 2015; data analysis was performed from April 23, 2014, to May 22, 2015. Participants included daily or weekly smokers willing to set a quit date within 1 month of enrollment. The study used email to invite all college and university students throughout Sweden to participate.The NEXit core program is initiated with a 1- to 4-week motivational phase during which participants can choose to set a stop date. The intervention group then received 157 text messages based on components of effective smoking cessation interventions for 12 weeks. The control group received 1 text every 2 weeks thanking them for participating in the study, with delayed access to the intervention.The primary outcomes were self-reported prolonged abstinence (not having smoked >5 cigarettes over the past 8 weeks) and 4-week point prevalence of complete smoking cessation shortly after the completion of the intervention (approximately 4 months after the quit date).A total of 1590 participants, mainly between 21 and 30 years of age, were randomized into the study; 827 (573 [69.3%] women) were allocated to the intervention group and 763 (522 [68.4%] women) were included in the control group. Primary outcome data were available for 783 (94.7%) of the intervention group and 719 (94.2%) of the control group. At baseline, participants were smoking a median (range) of 63 (1-238) and 70 (2-280) cigarettes per week, respectively. Eight-week prolonged abstinence was reported by 203 participants (25.9%) in the intervention group and 105 (14.6%) in the control group; 4-week point prevalence of complete cessation was reported by 161 (20.6%) and 102 (14.2%) participants, respectively, a mean (SD) of 3.9 (0.37) months after the quit date. The adjusted odds ratios (95% CIs) for these findings were 2.05 (1.57-2.67) and 1.56 (1.19-2.05), respectively.With the limitation of assessing only the short-term effect of the intervention, the effects observed in this trial are comparable with those for traditional smoking cessation interventions. The simple NEXit intervention has the potential to improve the uptake of effective smoking cessation interventions.isrctn.org Identifier: ISRCTN75766527.

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A randomized clinical trial of an interactive voice response and text message intervention for individuals with hypertension.

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