Interactive Text Messages Research Articles

A randomized pilot trial of a mobile phone–based brief intervention with personalized feedback and interactive text messaging to reduce driving after cannabis use and riding with a cannabis impaired driver

IntroductionDriving after cannabis use (DACU) and riding with a cannabis-impaired driver (RWCD) are national public health concerns. Though driving impairments and increased crash risk make DACU and RWCD two of the riskiest cannabis-related behaviors, many continue to drive after use and ride with others who are under the influence and do not view DACU or RWCD as dangerous. The current study examined the efficacy of an accessible, low-cost, mobile phone–based brief intervention aimed at reducing DACU and RWCD among college cannabis users in the context of a randomized three-group pilot trial. MethodParticipants were 97 college cannabis users (67.4 % women; average age = 21.34; 80.4 % Caucasian) who endorsed DACU at least three times in the past three months. After completing baseline measures, the study randomly assigned participants to one of three conditions: a) a substance impaired–driving personalized feedback plus MI-style interactive text messaging intervention (PF + MIT); b) a substance impaired–driving personalized feedback only intervention (PF); and c) a substance information control condition (IC). All conditions completed outcome measures three months postintervention. ResultsGeneralized linear mixed models (GLMM) analyses indicated that after controlling for sex, cannabis users in the PF + MIT condition significantly reduced DACU and RWCD over time compared to those in the IC condition. ConclusionsThese findings provide preliminary support for the short-term efficacy of a mobile phone–based intervention in decreasing DACU and RWCD among college cannabis users. Future research should determine whether these reductions in driving behaviors persist past three months.

Using mHealth to improve adherence and reduce blood pressure in individuals with hypertension and bipolar disorder (iTAB-CV): study protocol for a 2-stage randomized clinical trial

BackgroundCardiovascular disease in individuals with mental health conditions such as bipolar disorder is highly prevalent and often poorly managed. Individuals with bipolar disorder face significant medication adherence barriers, especially when they are prescribed multiple medications for other health conditions including hypertension. Poor adherence puts them at a disproportionate risk for poor health outcomes. As such, there is a need for effective interventions to improve hypertension medication adherence, particularly in patients that struggle with adherence due to mental health comorbidity.MethodsThis 5-year project uses a 2-stage randomized controlled trial design to evaluate a brief, practical adherence intervention delivered via interactive text messaging (iTAB-CV) along with self-monitoring of medication taking, mood, and home blood pressure (N = 100) compared to self-monitoring alone (N = 100). Prior to randomization, all participants will view an educational video that emphasizes the importance of medication for the treatment of hypertension and bipolar disorder. Those randomized to the texting intervention will receive daily text messages with predetermined content to address 11 salient domains as well as targeted customized messages for 2 months. This group will then be re-randomized to receive either a high (gradual taper from daily to weekly texts) or low booster (weekly texts) phase for an additional 2 months. All participants will be monitored for 52 weeks. The primary outcomes are systolic blood pressure and adherence to antihypertensive medication as determined by a self-reported questionnaire and validated with an automated pill-monitoring device. Secondary outcomes include adherence to bipolar disorder medications, psychiatric symptoms, health status, self-efficacy for medication-taking behavior, illness beliefs, medication attitudes, and habit strength.DiscussionThis study specifically targets blood pressure and mental health symptom control in people with bipolar and includes implementation elements in the study design intended to inform future scale-up. Promising pilot data and a theoretical model, which views sustained medication-taking behavior in the context of habit formation, suggests that this remotely delivered intervention may help advance care for this high-risk population and is amenable to both scale up and easy adaptation for other groups with poor medication adherence.Trial registrationThe study was registered at ClinicalTrials.gov (NCT04675593) on December 19, 2020.

Effectiveness of a Text Message Intervention to Reduce Texting While Driving Among Targeted Young Adults: A Randomized Controlled Trial

PurposeThis randomized clinical trial tested the efficacy of a 6-week text message program to reduce texting while driving (TWD) for young adults. MethodsEligible individuals recruited from four emergency departments from December 2019 to June 2021 were aged 18–25 years who reported TWD in the past 2 weeks. Participants were randomly assigned 1:1 to intervention:assessment control. The intervention arm (n = 57) received an automated interactive text message program, including weekly queries about TWD for 6 weeks with feedback and goal support to promote cessation of TWD. The assessment control arm (n = 55) received identical weekly TWD queries but no additional feedback. Outcomes were collected via web-based self-assessments at 6- and 12 weeks and analyzed under intent-to-treat models, presented as adjusted odds ratios (ORs) with 95% confidence intervals (CIs). ResultsThe mean (SD) age was 21.7 (2.1) years, 73 (65%) were female, and 40 (36%) were White. The 6-week follow-up rate was 77.7% (n = 87) and 12-week follow-up rate was 64.3% (n = 72). At 6 weeks, 52.6% (95% CI, 39.0%–66.0%) of intervention participants reported TWD versus 63.6% (95% CI, 49.6%–76.2%) of control participants (adjusted OR, 0.71; 95% CI, 0.32–1.59). At 12 weeks, 38.2% (95% CI, 22.8%–53.5%) of intervention participants reported TWD versus 69.3% (95% CI, 53.8%–84.7%) of control participants (adjusted OR, 0.29; 95% CI, 0.11–0.80). DiscussionAn interactive text message intervention was more effective at reducing self-reported TWD among young adults than assessment control at 12 weeks.

Effect of Graphic Warning Labels on Cigarette Pack–Hiding Behavior Among Smokers

The inclusion of graphic warning labels (GWLs) on cigarette packs is recommended for tobacco control but has not yet been implemented in the US. It is unknown whether and to what extent the inclusion of GWLs on cigarette packs affects smokers' willingness to display the packs in public. To determine whether the inclusion of GWLs on cigarette packs affects pack-hiding behavior among smokers in social settings. This community-based randomized clinical trial assessed smokers' real-world experience of using cigarettes repackaged to include GWLs (GWL packs) compared with standard US packs and blank packs over a 3-month intervention period with 12 months of follow-up between September 6, 2016, and December 3, 2019. The study included 357 participants aged 21 to 65 years from San Diego County, California, who smoked 5 or more cigarettes per day, were not actively planning to quit smoking, were not pregnant, and had no unstable medical conditions. Participants purchased and received cigarette packs through the study website. During the 1-month run-in period, participants received their usual US cigarette packs. During the 3-month intervention period, participants were randomized to receive GWL packs (study-manufactured packs with 3 rotating images under license from the Commonwealth of Australia; GWL pack group), blank packs (study-manufactured packs devoid of industry marketing imagery; blank pack group), or standard US packs (US pack group). Pack hiding was queried daily (with participants reporting behavior within the last 4 hours) and weekly via interactive text messages during the 1-month run-in and intervention periods. Self-reported smoking behavior was biochemically validated. Among 357 enrolled participants, the mean (SD) age was 39.3 (11.8) years; 195 participants (54.6%) were female, 40 (11.2%) were Hispanic, 243 (68.1%) were non-Hispanic White, and 74 (20.7%) were of other non-Hispanic races (including American Indian or Alaska Native, Asian or Pacific Islander, Black or African American, or multiracial). A total of 18 987 cigarette packs were purchased and delivered during the run-in and intervention periods. Daily querying showed that the inclusion of GWLs on cigarette packs increased the percentage of smokers who hid their packs at least some of the time from 41.3% (95% CI, 39.6%-43.0%) during the run-in period to 57.1% (95% CI, 55.9%-58.1%) by the end of the intervention period. In the postintervention period, returning to standard US packs reduced pack-hiding behavior to the levels observed during the run-in period. Pack hiding remained at run-in levels for both the blank pack group (35.2%; 95% CI, 33.6%-36.8%) and the US pack group (41.4%; 95% CI, 39.7%-43.1%]) throughout the study. Although even participants in the GWL group with the lowest prestudy tendency to conceal score (ie, 1) had a mean (SE) probability of pack hiding during the intervention of 0.84 (0.02), this group's probability of pack hiding decreased to a mean (SE) of 0.43 (0.03) after intervention. When social reactions to packs were queried at the end of the study, the modal response from participants in the GWL pack group was observers' aversive reactions to the packs, whereas the modal response from participants in the blank pack group was observers' positive interest in the study. Neither smoking prevalence nor consumption differed by group at any point in the study. In this randomized clinical trial, receiving cigarettes in GWL packs vs blank packs increased pack-hiding behavior in social settings, which may be associated with aversive reactions from observers. However, 12-month smoking behavior did not change. ClinicalTrials.gov Identifier: NCT02676193.

Implementing a mHealth intervention to increase colorectal cancer screening among high-risk cancer survivors treated with radiotherapy in the Childhood Cancer Survivor Study (CCSS)

BackgroundCancer survivors treated with any dose of radiation to the abdomen, pelvis, spine, or total body irradiation (TBI) are at increased risk for developing colorectal cancer (CRC) compared to the general population. Since earlier detection of CRC is strongly associated with improved survival, the Children’s Oncology Group (COG) Long-Term Follow-Up Guidelines recommend that these high-risk cancer survivors begin CRC screening via a colonoscopy or a multitarget stool DNA test at the age of 30 years or 5 years following the radiation treatment (whichever occurs last). However, only 37% (95% CI 34.1–39.9%) of high-risk survivors adhere to CRC surveillance. The Activating cancer Survivors and their Primary care providers (PCP) to Increase colorectal cancer Screening (ASPIRES) study is designed to assess the efficacy of an intervention to increase the rate of CRC screening among high-risk cancer survivors through interactive, educational text-messages and resources provided to participants, and CRC screening resources provided to their PCPs.MethodsASPIRES is a three-arm, hybrid type II effectiveness and implementation study designed to simultaneously evaluate the efficacy of an intervention and assess the implementation process among participants in the Childhood Cancer Survivor Study (CCSS), a North American longitudinal cohort of childhood cancer survivors. The Control (C) arm participants receive electronic resources, participants in Treatment arm 1 receive electronic resources as well as interactive text messages, and participants in Treatment arm 2 receive electronic educational resources, interactive text messages, and their PCP’s receive faxed materials. We describe our plan to collect quantitative (questionnaires, medical records, study logs, CCSS data) and qualitative (semi-structured interviews) intervention outcome data as well as quantitative (questionnaires) and qualitative (interviews) data on the implementation process.DiscussionThere is a critical need to increase the rate of CRC screening among high-risk cancer survivors. This hybrid effectiveness-implementation study will evaluate the effectiveness and implementation of an mHealth intervention consisting of interactive text-messages, electronic tools, and primary care provider resources. Findings from this research will advance CRC prevention efforts by enhancing understanding of the effectiveness of an mHealth intervention and highlighting factors that determine the successful implementation of this intervention within the high-risk cancer survivor population.Trial registrationThis protocol was registered at clinicaltrials.gov (identifier NCT05084833) on October 20, 2021.

Values-Based Interventions Increase Reenrollment and Equity among Community College Pre-Allied Health Students

Addressing labor shortages within nursing and allied health professions, which have been exacerbated by the COVID-19 pandemic, requires increasing persistence and equity among community college students pursuing these fields. In this study, we adapted and combined three values-based interventions (values affirmation, goal congruence, and utility values) into one treatment, delivered via interactive text messages, with the goal to support reenrollment­ among pre-allied health students during the pandemic. Using institutional data from a statewide community college system, we randomized pre-allied health students who were enrolled in Fall 2019 and/or Spring 2020, and who had a valid mobile number on file, into treatment (n = 1,649) or control (n = 1,650) groups. Fully treated students received an average of 17 text messages over 8 weeks of Summer 2020; control students received business as usual support from the college. After adjusting for baseline differences in prior enrollment, the treatment significantly increased reenrollment by 3 percentage points (74% vs. 71%). Examination of individual differences revealed that effects were concentrated among men (+11 percentage points), Black/African American students (+7 percentage points), and students who were not enrolled in Spring 2020 (+13 percentage points). Values-based interventions, therefore, can be an important tool for addressing shortages and inequities in healthcare education and the labor force, an important step toward improving public health. Moreover, community colleges seeking to engage students who withdrew before or during the COVID-19 pandemic should leverage evidence-based practices to boost reenrollment.

Pickle Juice Intervention for Cirrhotic Cramps Reduction: The PICCLES Randomized Controlled Trial

Muscle cramps are common among persons with cirrhosis and associated with poor health-related quality of life. Treatment options are limited. We sought to determine whether pickle juice can improve muscle cramp severity. We enrolled 82 patients with cirrhosis and a history of >4 muscle cramps in the previous month from December 2020 to December 2021. Patients were randomized 1:1 to sips of pickle juice vs tap water at cramp onset. Our primary outcome assessed at 28 days was the change in cramp severity measured by the visual analog scale for cramps (VAS-cramps, scaled 0-10). Cramps were assessed 10 times over 28 days using interactive text messages. Secondary outcomes included the proportion of days with VAS-cramps <5, change in sleep quality, and global health-related quality of life measured using the EQ-5D. Overall, 74 patients completed the trial, aged 56.6 ± 11.5 years, 54% male, 41% with ascites, 38% with encephalopathy, and model for end-stage liver disease-sodium score 11.2 ± 4.9. Many patients were receiving other cramp therapies at baseline. The baseline VAS for cramps was 4.2 ± 3.4, the EQ-5D was 0.80 ± 0.10, and 43% rated sleep as poor. At trial completion, the respective values for the pickle juice and control arms were -2.25 ± 3.61 points on the VAS for cramps, compared with control tap water (-0.36 ± 2.87), P = 0.03; a proportion of cramp-days with VAS-cramps <5 were 46% vs 35% (P = 0.2); and the change in sleep quality was not different (P = 0.1). The end-of-trial EQ-5D was 0.78 ± 0.10 vs 0.80 ± 0.10 (P = 0.3). No differences in weight change were observed for those with and without ascites. In a randomized trial, sips of pickle brine consumed at cramp onset improve cramp severity without adverse events.

Feasibility and Short-Term Effects of a Multi-Component Emergency Department Blood Pressure Intervention: A Pilot Randomized Trial.

BackgroundEmergency department (ED) visits can be opportunities to address uncontrolled hypertension. We sought to compare short‐term blood pressure measures between the Vanderbilt Emergency Room Bundle (VERB) intervention and usual care plus education.Methods and ResultsWe conducted a randomized trial of 206 adult patients with hypertension and elevated systolic blood pressure (SBP) presenting to 2 urban emergency departments in Tennessee, USA. The VERB intervention included educational materials, a brief motivational interview, pillbox, primary care engagement letter, pharmacy resources, and 45 days of informational and reminder text messages. The education arm received a hypertension pamphlet. After 78 participants were enrolled, text messages requested confirmation of receipt. The primary clinical outcome was 30‐day SBP. The median 30‐day SBP was 122 and 126 mm Hg in the VERB and education arms, respectively. We estimated the mean 30‐day SBP to be 3.98 mm Hg lower in the VERB arm (95% CI, −2.44 to 10.4; P=0.22). Among participants enrolled after text messages were adapted, the respective median SBPs were 121 and 130 mm Hg, and we estimated the mean 30‐day SBP to be 8.57 mm Hg lower in the VERB arm (95% CI, 0.98‒16.2; P=0.027). In this subgroup, the median response rate to VERB text messages was 56% (interquartile range, [26%‒80%]).ConclusionsThis pilot study demonstrated feasibility and found an improvement in SBP for the subgroup for whom interactive messages were featured. Future studies should evaluate the role of interactive text messaging as part of a comprehensive emergency department intervention to improve blood pressure control.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT02672787.

Registrar Information System through SMS

The Registrar Information System through SMS is design and develop a computer-based system that is able to provide a real-time information through SMS to students regarding of their academic records. It has a two-way interactive text messaging functionality in a Registrar’s office of Northern Iloilo Polytechnic State College Main Campus, Estancia, Iloilo. The architectural design used in this system is two-tier architecture. The developed system employed a descriptive and developmental research design. Respondents of the study were the 354 students enrolled officially in School Year 2016-2017 using a standard questionnaire International Standard Organization / International Electrotechnical Commission 25010. The Rapid Application Development Model was used in the Software Development Life Cycle. MySQL for the database, vb.net language and Windows operating system development environment. The usability of the feature of the developed system is Very Good in terms of delivering important academic information to every student. The performance of the developed system is fully functional when it comes to all the processes such as enrolling, encoding the grades, reliable and efficient to the students in sending/ receiving academic information provided to clienteles.

Mindfulness and Mobile Health for Quitting Smoking: A Qualitative Study Among Predominantly African American Adults with Low Socioeconomic Status.

Low-income and African American adults experience severe tobacco-related health disparities. Mindfulness-based interventions show promise for promoting smoking cessation, but most mindfulness research has focused on higher income, Caucasian samples. "iQuit Mindfully" is a personalized, interactive text messaging program that teaches mindfulness for smoking cessation. This qualitative study sought feedback from predominantly low-income African American smokers, to improve the intervention for this priority population. After receiving 8 weekly group sessions of Mindfulness-Based Addiction Treatment for smoking cessation and between-session iQuit Mindfully text messages, participants (N=32) completed semi-structured interviews. Participants were adult cigarette smokers (90.6% African American, 62.6% annual income <$30,000, mean age 45.1 [±12.9]). Interviews inquired about participants' experiences with and suggestions for improving iQuit Mindfully, including message content, number, and timing. Interviews were audio-recorded, transcribed verbatim, and coded by a team of 5 coders in NVivo. The coding manual was developed based on response categories from the interview guide and themes emerging from the data. Themes were organized into a conceptual model of factors related to engagement with the mHealth program. Response categories included helpful aspects (e.g., themes of social support, mindfulness, personalization); unhelpful/disliked aspects (e.g., too many/repetitive messages); links between in-person sessions and texts; and suggestions (e.g., changes to number/timing and more personalization). Findings provide insight into participants' day-to-day experiences with iQuit Mindfully and suggest ways to improve mHealth programs among low-income and African American adults.

Using Interactive Text Messaging to Improve Diet Quality and Increase Redemption of Foods Approved by the Special Supplemental Nutrition Program for Women, Infants, and Children: Protocol for a Cohort Feasibility Study.

BackgroundChildren in the United States eat too few fruits, vegetables, and whole grains and too many energy-dense foods; these dietary behaviors are associated with increased risk of obesity. Maternal diet plays a key role in shaping children's diets; however, many mothers have poor diet quality, especially those living in low-income households. The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) is a federal nutrition assistance program that provides mothers and children with nutrient-dense foods, and those who participate have better diet quality. However, many mothers do not redeem all their WIC-approved foods. Thus, there is a need to create effective interventions to improve diet quality, especially among low-income children and families.ObjectiveThis paper aims to describe the development and protocol for a study to evaluate the feasibility, satisfaction, and preliminary efficacy of a fully automated text messaging intervention as a strategy to improve maternal diet quality and the redemption of WIC-approved foods.MethodsWe describe the use of the framework developed for the description of nonrandomized feasibility studies. Using an observational, prospective cohort study design, we will recruit mothers enrolled in WIC with a child aged ≤2 years. Participants will receive automated SMS text messages aimed at improving the redemption of WIC-approved foods to improve the participants’ diet quality for 12 weeks. All outcome measures will be analyzed using descriptive and inferential statistics. Qualitative data will be analyzed using thematic analysis.ResultsData collection for this study began in March 2021. We expect the study results to be available within 9 months of study commencement. The results will shed light on the feasibility, acceptability, and effectiveness of using automated text messages as a behavior change strategy for mothers enrolled in WIC.ConclusionsThe results of this pilot study will explore whether this digital behavioral intervention, which will deliver nutrition guidance in accordance with the Dietary Guidelines for Americans using interactive self-monitoring and feedback, is feasible and acceptable. This will lay the foundation for a larger evaluation to determine efficacy for improving diet quality in those most at risk for obesity.Trial RegistrationClinicalTrials.gov NCT04098016; https://clinicaltrials.gov/ct2/show/NCT04098016International Registered Report Identifier (IRRID)DERR1-10.2196/32441

Incorporating African American Veterans' Success Stories for Hypertension Management: Developing a Behavioral Support Texting Protocol.

BackgroundPeer narratives engage listeners through personally relevant content and have been shown to promote lifestyle change and effective self-management among patients with hypertension. Incorporating key quotations from these stories into follow-up text messages is a novel way to continue the conversation, providing reinforcement of health behaviors in the patients’ daily lives.ObjectiveIn our previous work, we developed and tested videos in which African American Veterans shared stories of challenges and success strategies related to hypertension self-management. This study aims to describe our process for developing a text-messaging protocol intended for use after viewing videos that incorporate the voices of these Veterans.MethodsWe used a multistep process, transforming video-recorded story excerpts from 5 Veterans into 160-character texts. We then integrated these into comprehensive 6-month texting protocols. We began with an iterative review of story transcripts to identify vernacular features and key self-management concepts emphasized by each storyteller. We worked with 2 Veteran consultants who guided our narrative text message development in substantive ways, as we sought to craft culturally sensitive content for texts. Informed by Veteran input on timing and integration, supplementary educational and 2-way interactive assessment text messages were also developed.ResultsWithin the Veterans Affairs texting system Annie, we programmed five 6-month text-messaging protocols that included cycles of 3 text message types: narrative messages, nonnarrative educational messages, and 2-way interactive messages assessing self-efficacy and behavior related to hypertension self-management. Each protocol corresponds to a single Veteran storyteller, allowing Veterans to choose the story that most resonates with their own life experiences.ConclusionsWe crafted a culturally sensitive text-messaging protocol using narrative content referenced in Veteran stories to support effective hypertension self-management. Integrating narrative content into a mobile health texting intervention provides a low-cost way to support longitudinal behavior change. A randomized trial is underway to test its impact on the lifestyle changes and blood pressure of African American Veterans.Trial RegistrationClinicalTrials.gov NCT03970590; https://clinicaltrials.gov/ct2/show/NCT03970590International Registered Report Identifier (IRRID)DERR1-10.2196/29423

The effect of weekly interactive text-messaging on early infant HIV testing in Kenya: a randomised controlled trial (WelTel PMTCT)

Mother-to-child transmission of HIV remains a significant concern in Africa despite earlier progress. Early infant diagnosis (EID) of HIV is crucial to reduce mortality among infected infants through early treatment initiation. However, a large proportion of HIV-exposed infants are still not tested in Kenya. Our objective was to investigate whether weekly interactive text-messages improved prevention of mother-to-child transmission (PMTCT) of HIV care outcomes including EID HIV testing. This multicentre, parallel-group, randomised, open-label trial included six antenatal care clinics across western Kenya. Pregnant women living with HIV, aged 18 years or older, with mobile phone access, were randomised in a 1:1 ratio to weekly text messages that continued until 24 months postpartum, asking “How are you?” (“Mambo?”) to which they were asked to respond within 48 h, or a control group. Healthcare workers contacted participants reporting problems and non-responders by phone. Participants in both groups received routine PMTCT care. The prespecified secondary outcome reported in this paper is EID HIV testing by eight weeks of age (blinded outcome assessment). Final 24-months trial results will be published separately. We estimated risk ratios using Poisson regression with robust standard errors. Between June 2015–July 2016, we screened 735 pregnant women, of whom 600 were enrolled: 299 were allocated to the intervention and 301 to the control group. By eight weeks of age, the uptake of EID HIV testing out of recorded live births was 85.5% in the intervention and 84.7% in the control group (71.2% vs. 71.8% of participants randomised, including miscarriages, stillbirths, etc.). The intention-to-treat risk ratio was 0.99; 95% CI: 0.90–1.10; p = 0.89. The proportion of infants diagnosed with HIV was 0.8% in the intervention and 1.2% in the control group. No adverse events were reported. We found no evidence to support that the WelTel intervention improved EID HIV testing. A higher uptake of EID testing than expected in both groups may be a result of lower barriers to EID testing and improved PMTCT care in western Kenya, including the broader standard use of mobile phone communication between healthcare workers and patients. (ISRCTN No. 98818734. Funded by the European-Developing Countries Clinical Trial Partnership and others).

Estimating the impact of engagement with digital health interventions on patient outcomes in randomized trials.

Guidance is needed on studying engagement and treatment effects in digital health interventions, including levels required for benefit. We evaluated multiple analytic approaches for understanding the association between engagement and clinical outcomes. We defined engagement as intervention participants' response rate to interactive text messages, and considered moderation, standard regression, mediation, and a modified instrumental variable (IV) analysis to investigate the relationship between engagement and clinical outcomes. We applied each approach to two randomized controlled trials featuring text message content in the intervention: REACH (Rapid Encouragement/Education and Communications for Health), which targeted diabetes, and VERB (Vanderbilt Emergency Room Bundle), which targeted hypertension. In REACH, the treatment effect on hemoglobin A1c was estimated to be -0.73% (95% CI: [-1.29, -0.21]; P = 0.008), and in VERB, the treatment effect on systolic blood pressure was estimated to be -10.1 mmHg (95% CI: [-17.7, -2.8]; P = 0.007). Only the IV analyses suggested an effect of engagement on outcomes; the difference in treatment effects between engagers and non-engagers was -0.29% to -0.51% in the REACH study and -1.08 to -3.25 mmHg in the VERB study. Standard regression and mediation have less power than a modified IV analysis, but the IV approach requires specification of assumptions. This is the first review of the strengths and limitations of various approaches to evaluating the impact of engagement on outcomes. Understanding the role of engagement in digital health interventions can help reveal when and how these interventions achieve desired outcomes.

A Nurse-Navigated, Postpartum Support Text Messaging Intervention: Satisfaction Among Primiparous Women.

More than 50% of maternal deaths in the United States occur during the first year following childbirth. Nearly 40% of these deaths occur between days 1 and 41 of the postpartum period. Historically, women receive less attention from healthcare providers during the postpartum period when compared with the care provided during pregnancy and childbirth. Women may not return for scheduled follow-up care until 4 to 6 weeks after birth, if they return at all. The role of postpartum nurse navigator (PPNN) was developed to deliver a novel, text messaging intervention as part of a randomized controlled trial to 43 primiparous women who experienced an unplanned cesarean birth. Through daily, interactive text messaging, the PPNN assessed study participants' general well-being, assisted with symptom navigation, offered anticipatory guidance, and provided informational support until 4 weeks postpartum. Satisfaction with the intervention was evaluated using a survey that incorporated quantitative and qualitative responses. Overwhelmingly, 93% of participants rated their overall experience with the text messaging intervention as outstanding or good. At least 95% of the participants indicated that they would likely choose to receive daily text messaging from a PPNN following a subsequent birth. Convenient access to professional nurse support for women postbirth warrants further evaluation.

Effect of Graphic Warning Labels on Cigarette Packs on US Smokers’ Cognitions and Smoking Behavior After 3 Months

The US Food and Drug Administration's implementation of graphic warning labels (GWLs) on cigarette packs is under challenge in US courts. To determine whether GWLs can affect US smokers' perceptions about their cigarettes or health consequences and changes in smoking behavior. This study was a randomized clinical trial of the effect of a 3-month, real-world experience of cigarettes with GWL packaging. Community recruitment was done from September 2016 through December 2019 of daily smokers from San Diego, California, aged 21 to 65 years, who were not ready to quit. Participants were randomized to purchase and receive cigarettes in 1 of 3 pack designs: GWL, blank, or standard US pack. Data analysis was performed from July 2020 to February 2021. The study manufactured GWL cigarette packs (3 versions with Australian-licensed images) and packs devoid of marketing. For 3 months, participants purchased GWL, blank, or standard US pack cigarettes that were delivered to their home. Smoking-related cognitions and behavior were queried by daily and weekly interactive text messages. Smoking behavior was self-reported before and after the intervention by 96% of randomized participants and was biochemically validated on a subsample. The study sample included 357 participants (195 women [54.6%]; mean [SD] age, 39.5 [11.9] years); 116 were randomized to the standard US pack group, 118 were randomized to the GWL pack group, and 125 were randomized to the blank pack group. Over the 3 months, participants who received the GWL packs had reduced positive perceptions of recent cigarettes smoked compared with participants who received the branded US pack (mean difference, -0.46 SD; 95% CI, -0.73 SD to -0.20 SD; P < .001). Health concerns increased in all groups, with a significant increase in the GWL group vs the US pack group (mean difference, 0.35 SD; 95% CI, 0.09 SD to 0.62 SD; P = .002). Quitting cognitions increased in all study groups, with a peak mean change of 0.60 SD for GWL participants vs 0.34 SD for US pack participants (mean difference, 0.55 SD; 95% CI, 0.28 SD to 0.81 SD; P < .001). GWL participants had slightly more cigarette abstinence periods per week than the US pack group, but the difference was not significant (adjusted odds ratio, 1.06; 95% CI, 0.99 to 1.13). At 3 months, there was no between-group difference in any smoking behavior. The blank pack group was similar to the US pack group on all measures. These findings suggest that the introduction of GWL packs appears to decrease positive perceptions of cigarettes and increase quitting cognitions in the short term. However, additional complementary tobacco control strategies may be necessary for GWL packs to be associated with reduced smoking behavior. ClinicalTrials.gov Identifier: NCT02676193.

Computer delivered intervention for alcohol and sexual risk reduction among women attending an urban sexually transmitted infection clinic: A randomized controlled trial

ObjectiveWe sought to determine if a computer delivered brief alcohol intervention (CBI) with or without interactive voice response counseling and text messages (CBI-IVR-TM), reduced alcohol use and sexual risk behaviors compared to attention control. MethodsWe conducted a 3-arm RCT among women (n = 439) recruited from Baltimore City Sexually Transmitted Infection (STI) Clinics. Eligibility included: 1) consumption of >7 drinks per week or 2) ≥2 episodes of heavy episodic drinking or ≥2 episodes of sex under the influence of alcohol in the prior three months. Research assessments conducted at baseline, 3, 6 and 12 months included a 30-day Timeline Followback querying daily alcohol use, drug use, and sexual activity. We used the MINI International Neuropsychiatric Interview-DSM-IV to ascertain drinking severity. Primary alcohol outcomes included: drinking days, heavy drinking days, drinks per drinking day. Secondary sexual risk outcomes included number of sexual partners, days of condomless sex, and days of condomless sex under the influence of drugs and alcohol. ResultsMedian age was 31 (IQR 25–44 years), 88% were African American, 65% reported current recreational drug use, and 26% endorsed depressive symptoms. On the MINI 66% met criteria for alcohol use disorder (49% alcohol dependence, 18% abuse). At follow-up, all three groups reduced drinking days, heavy drinking days, drinks per drinking day and drinks per week with no significant differences between study arms. There was no difference in sexual risk outcomes among the groups. ConclusionsAmong women attending an urban STI clinic single session CBI with or without IVR and text message boosters was insufficient to reduce unhealthy alcohol use or sexual risk behaviors beyond control. The high severity of alcohol use and the prevalence of mental health symptoms and other substance use comorbidity underscores the importance of developing programs that address not only alcohol use but other determinants of STI risk among women.

Nudge me: tailoring text messages for prescription adherence through N-of-1 interviews.

Almost 50% of patients with cardiovascular diseases face challenges in taking medications and increased morbidity and mortality. Text messaging may impact medication refill behavior and can be delivered at scale to patients by texting mobile phones. To obtain feedback from persons with chronic conditions on the design of interactive text messages and determine language of message for making messages that can motivate patients to refill medications on time. We purposively sampled 35 English and Spanish speaking patients with at least one chronic condition from three large healthcare delivery systems to participate in N-of-1 video-based synchronous interviews. Research assistants shared ideas for theory-informed text messages with content intended to persuade patients to refill their medication. We transcribed recorded interviews and conducted a content analysis to identify strategies to employ generating a dynamic interactive text message library intended to increase medication refill. Those interviewed were of diverse age and race/ethnicity and typical of persons with multiple chronic conditions. Several participants emphasized that personally tailored and positively framed messages would be more persuasive than generic and/or negative messages. Some patients appreciated humor and messages that could evoke a sense of social support from their providers and rejected the use of emojis. Messages to remind patients to refill medications may facilitate improvements in adherence, which in turn can improve chronic care. Designing messages that are persuasive and can prompt action is feasible and should be considered given the ease with which such messages can be delivered automatically at scale.

A medical peer-delivered intervention comprising brief motivational interviewing via instant-messaging interaction to reduce drug misuse among youth in Hong Kong: A protocol for a randomised controlled trial

AimsYouth are frequently exposed to drugs, and most youth who misuse drugs are reluctant to seek help from services due to the worry of others being judgmental, lacking expertise, exposing their personal information, or informing their parents. Considering these concerns, we propose to evaluate the effectiveness of a medical peer-delivered intervention comprising brief motivational interviewing via instant-messaging interaction in reducing drug misuse among youth in Hong Kong.MethodsA two-group single-blind, randomised controlled trial will be conducted. Multiple approaches, including online and face-to-face methods, will be used to recruit the participants. The participants, aged 25 years or younger and reporting any drugs that they have taken within the past 30 days, will be recruited and randomised to receive either brief motivational interviewing via interactive instant-messaging (the intervention) or general health text-messages (comparator). The primary outcome will be the change in the participants’ reductions in self-reported drug consumption at 12 months compared to that at baseline. The secondary outcomes will be the changes in the drug-abusing participants’ reductions in self-reported drug consumption at 6 months, the changes in the drug-quitting participants’ 6- and 12-month contemplation stages and relapse risk compared to that at baseline, 30 days’ self-reported drug abstinence at 6 and 12 months, and the treatment needs and motivation at 6 and 12 months compared to that at baseline. The effectiveness of the proposed intervention will be examined with adjusted regression models, with adjustment for baseline characteristics and the use of an intention-to‐treat approach.DiscussionThis proposed study will be the first randomised controlled trial to assess the effectiveness of a medical peer-delivered interactive intervention to reduce drug misuse among youth in Hong Kong. The proposed intervention has the potential to increase the help-seeking behaviour and intention to quit among youth who misuse drugs. As a result, more youth misusing drugs may be helped to abstain from drugs. This proposed study will inform decisions on whether it is worthwhile to invest resources in large-scale implementation of such an intervention.

Effectiveness of a Vaping Cessation Text Message Program Among Young Adult e-Cigarette Users

e-Cigarettes are the most commonly used tobacco product among young adults (YAs). Despite the harms of nicotine exposure among YAs, there are few, if any, empirically tested vaping cessation interventions available. To determine the effectiveness of a text message program for vaping cessation among YAs vs assessment-only control. A parallel, 2-group, double-blind, individually randomized clinical trial was conducted from December 2019 to November 2020 among YA e-cigarette users. Eligible individuals were US residents aged 18 to 24 years who owned a mobile phone with an active text message plan, reported past 30-day e-cigarette use, and were interested in quitting in the next 30 days. Participants were recruited via social media ads, the intervention was delivered via text message, and assessments were completed via website or mobile phone. Follow-up was conducted at 1 and 7 months postrandomization; follow-up data collection began January 2020 and ended in November 2020. The study was prespecified in the trial protocol. All participants received monthly assessments via text message about e-cigarette use. The assessment-only control arm (n = 1284) received no additional intervention. The active intervention arm (n = 1304) also received This is Quitting, a fully automated text message program for vaping cessation that delivers social support and cognitive and behavioral coping skills training. The primary outcome was self-reported 30-day point prevalence abstinence (ppa) at 7 months analyzed under intention-to-treat analysis, which counted nonresponders as vaping. Secondary outcomes were 7-day ppa under intention-to-treat analysis and retention weighted complete case analysis of 30-day and 7-day ppa. Of the 2588 YA e-cigarette users included in the trial, the mean (SD) age was 20.4 (1.7) years, 1253 (48.4%) were male, 2159 (83.4%) were White, 275 (10.6%) were Hispanic, and 493 (19.0%) were a sexual minority. Most participants (n = 2129; 82.3%) vaped within 30 minutes of waking. The 7-month follow-up rate was 76.0% (n = 1967), with no differential attrition. Abstinence rates were 24.1% (95% CI, 21.8%-26.5%) among intervention participants and 18.6% (95% CI, 16.7%-20.8%) among control participants (odds ratio, 1.39; 95% CI, 1.15-1.68; P < .001). No baseline variables moderated the treatment-outcome relationship, including nicotine dependence. Results of this randomized clinical trial demonstrated that a tailored and interactive text message intervention was effective in promoting vaping cessation among YAs. These results establish a benchmark of intervention effectiveness. ClinicalTrials.gov Identifier: NCT04251273.