Usability and Acceptability of a Conversational Agent Health Education App (Nthabi) for Young Women in Lesotho: Quantitative Study.

BACKGROUND: Young women in Lesotho face myriad sexual and reproductive health problems. There is little time to provide health education to women in low-resource settings with critical shortages of human resources for health. OBJECTIVE: This study aims to determine the acceptability and usability of a conversational agent system, the Nthabi health promotion app, which was culturally adapted for use in Lesotho. METHODS: We conducted a descriptive quantitative study, using a 22-item Likert scale survey to assess the perceptions of the usability and acceptability of 172 young women aged 18-28 years in rural districts of Lesotho, who used the system on either smartphones or tablets for up to 6 weeks. Descriptive statistics were used to calculate the averages and frequencies of the variables. χ2 tests were used to determine any associations among variables. RESULTS: A total of 138 participants were enrolled and completed the survey. The mean age was 22 years, most were unmarried, 56 (40.6%) participants had completed high school, 39 (28.3%) participants were unemployed, and 88 (63.8%) participants were students. Respondents believed the app was helpful, with 134 (97.1%) participants strongly agreeing or agreeing that the app was "effective in helping them make decisions" and "could quickly improve health education and counselling." In addition, 136 (98.5%) participants strongly agreed or agreed that the app was "simple to use," 130 (94.2 %) participants reported that Nthabi could "easily repeat words that were not well understood," and 128 (92.7%) participants reported that the app "could quickly load the information on the screen." Respondents were generally satisfied with the app, with 132 (95.6%) participants strongly agreeing or agreeing that the health education content delivered by the app was "well organised and delivered in a timely way," while 133 (96.4%) participants "enjoyed using the interface." They were satisfied with the cultural adaptation, with 133 (96.4%) participants strongly agreeing or agreeing that the app was "culturally appropriate and that it could be easily shared with a family or community members." They also reported that Nthabi was worthwhile, with 127 (92%) participants reporting that they strongly agreed or agreed that they were "satisfied with the application and intended to continue using it," while 135 (97.8%) participants would "encourage others to use it." Participants aged 18-24 years (vs those aged 25-28 years) agreed that the "Nthabi app was simple to use" (106/106, 100% vs 30/32, 98.8%; P=.01), and agreed that "the educational content was well organised and delivered in a timely way" (104/106, 98.1% vs 28/32, 87.5%; P=.01). CONCLUSIONS: These results support further study of conversational agent systems as alternatives to traditional face-to-face provision of health education services in Lesotho, where there are critical shortages of human resources for health. TRIAL REGISTRATION: ClinicalTrials.gov NCT04354168; https://www.clinicaltrials.gov/study/NCT04354168.

Adaptation of the Gabby conversational agent system to improve the sexual and reproductive health of young women in Lesotho.

Introduction: Young women from the low-middle-income country of Lesotho in southern Africa frequently report limited knowledge regarding sexual and reproductive health issues and engage in risky sexual behaviors. The purpose of this study is to describe the adaptation of an evidence-based conversational agent system for implementation in Lesotho and provide qualitative data pertaining to the success of the said adaptation. Methods: An embodied conversational agent system used to provide preconception health advice in the United States was clinically and culturally adapted for use in the rural country of Lesotho in southern Africa. Inputs from potential end users, health leaders, and district nurses guided the adaptations. Focus group discussions with young women aged 18-28 years who had used the newly adapted system renamed "Nthabi" for 3-4 weeks and key informant interviews with Ministry of Health leadership were conducted to explore their views of the acceptability of the said adaptation. Data were analyzed using NVivo software, and a thematic content analysis approach was employed in the study. Results: A total of 33 women aged 18-28 years used Nthabi for 3-4 weeks; eight (24.2%) of them were able to download and use the app on their mobile phones and 25 (75.8%) of them used the app on a tablet provided to them. Focus group participants (n = 33) reported that adaptations were culturally appropriate and provided relevant clinical information. The participants emphasized that the physical characteristics, personal and non-verbal behaviors, utilization of Sesotho words and idioms, and sensitively delivered clinical content were culturally appropriate for Lesotho. The key informants from the Ministry leadership (n = 10) agreed that the adaptation was successful, and that the system holds great potential to improve the delivery of health education in Lesotho. Both groups suggested modifications, such as using the local language and adapting Nthabi for use by boys and young men. Conclusions: Clinically tailored, culturally sensitive, and trustworthy content provided by Nthabi has the potential to improve accessibility of sexual and reproductive health information to young women in the low-middle-income country of Lesotho.

An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial.

BACKGROUND: In the veteran community, chronic pain is particularly prevalent and often debilitating. Until recently, veterans with chronic pain were offered primarily pharmacological intervention options, which rarely suffice and can also have negative health consequences. To better address chronic pain in veterans, the Veterans Health Administration has invested in novel, nonpharmacological behavior interventions that target both pain management and chronic pain-related functional issues. One approach, acceptance and commitment therapy (ACT) for chronic pain, is supported by decades of efficacy evidence for improving pain outcomes; however, ACT can be difficult to obtain owing to issues such as a lack of trained therapists or veterans having difficulty committing to the time and resources needed for the full clinician-led ACT protocol. Given the strong ACT evidence base combined with access limitations, we set out to develop and evaluate Veteran ACT for Chronic Pain (VACT-CP), an online program guided by an embodied conversational agent to improve pain management and functioning. OBJECTIVE: The aims of this study are to develop, iteratively refine, and then conduct a pilot feasibility randomized controlled trial (RCT) of a VACT-CP group (n=20) versus a waitlist and treatment-as-usual control group (n=20). METHODS: This research project includes 3 phases. In phase 1, our research team consulted with pain and virtual care experts, developed the preliminary VACT-CP online program, and conducted interviews with providers to obtain their feedback on the intervention. In phase 2, we incorporated feedback from phase 1 into the VACT-CP program and completed initial usability testing with veterans with chronic pain. In phase 3, we are conducting a small pilot feasibility RCT, with the primary outcome being assessment of usability of the VACT-CP system. RESULTS: This study is currently in phase 3; recruitment for the RCT began in April 2022 and is expected to continue through April 2023. Data collection is expected to be completed by October 2023, with full data analysis completed by late 2023. CONCLUSIONS: The findings from this research project will provide information on the usability of the VACT-CP intervention, as well as secondary outcomes related to treatment satisfaction, pain outcomes (pain-related daily functioning and pain severity), ACT processes (pain acceptance, behavioral avoidance, and valued living), and mental and physical functioning. TRIAL REGISTRATION: ClinicalTrials.gov NCT03655132; https://clinicaltrials.gov/ct2/show/NCT03655132. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45887.

MyLynch: A Patient-Facing Clinical Decision Support Tool for Genetically-Guided Personalized Medicine in Lynch Syndrome.

Lynch syndrome (LS) is a hereditary cancer susceptibility condition associated with varying cancer risks depending on which of the five causative genes harbors a pathogenic variant; however, lifestyle and medical interventions provide options to lower those risks. We developed MyLynch, a patient-facing clinical decision support (CDS) web application that applies genetically-guided personalized medicine (GPM) for individuals with LS. The tool was developed in R Shiny through a patient-focused iterative design process. The knowledge base used to estimate patient-specific risk leveraged a rigorously curated literature review. MyLynch informs LS patients of their personal cancer risks, educates patients on relevant interventions, and provides patients with adjusted risk estimates, depending on the interventions they choose to pursue. MyLynch can improve risk communication between patients and providers while also encouraging communication among relatives with the goal of increasing cascade testing. As genetic panel testing becomes more widely available, GPM will play an increasingly important role in patient care, and CDS tools offer patients and providers tailored information to inform decision-making. MyLynch provides personalized cancer risk estimates and interventions to lower these risks for patients with LS.

Design, rationale, and baseline characteristics of a randomized controlled trial evaluating a mobile relational agent to enhance atrial fibrillation self-care.

Atrial fibrillation (AF) is a chronic cardiovascular disease that frequently causes disruptive symptoms, adverse outcomes, and poor health-related quality of life (HRQoL). We have developed a mobile health application for individuals with AF which provides a longitudinal, patient-centered program to improve self-care. The defining feature of the application is the use of a relational agent, which uses synthetic speech accompanied by animation to provide health education, empathic counseling, and monitoring. In the present manuscript we present the design, rationale, and baseline characteristics of participants enrolled in "A Mobile Relational Agent to Enhance Atrial Fibrillation Self-Care Trial," a randomized trial testing the effectiveness the application for urban-dwelling individuals with AF being treated with oral anticoagulation for prevention of thromboembolic ischemic stroke. This is a single-center, parallel-arm randomized trial that assigned patients to the novel application (relational agent) versus a control intervention (WebMD). This ongoing RCT aims to determine the effect of the mobile health application on: (1) anticoagulation adherence; (2) patient-centered outcomes (quality of life and symptoms); and (3) health care utilization. The primary outcome, anticoagulation adherence, will be measured using the proportion of days covered (PDC). The study completed enrollment on April 1, 2022 (final enrollment n = 243 participants) with expected completion date of April 2023. (http://clinicaltrials.gov registration NCT04075994).

Change in Sexual and Reproductive Health Knowledge among Young Women Using the Conversational Agent "Nthabi" in Lesotho: A Clinical Trial.

Background: Young women worldwide face problems like unwanted pregnancy and sexually transmitted infections. Providing sexual and reproductive health education to this population remains a priority. It is unknown if using digital health interventions to deliver health education in human resource-constrained settings is effective. Methods: We conducted a clinical trial of the Nthabi intervention to determine participant's knowledge before and after discussion of family planning, folic acid and healthy eating among young women aged 18-28 years in two rural districts of Lesotho who used the Nthabi conversational agent system on either smartphones or tablets for up to six weeks. The number of correct pre- and post-test responses were compared using generalized linear models that directly estimated the proportions and percentages of correct responses. Results: Of the 172 participants enrolled, the mean age was 22.5 years, 91% were unmarried, 69% completed high school, 23% were unemployed and 66% were students. The mean number of interactions with Nthabi was Family planning was chosen to be discussed by 82 (52.2%), of the 172 participants and of those, 49 (59.8%) completed the content on this topic, and 26 (53.1%) completed the post-test. For the 11 questions about family planning, there were 717 (76.6%) correct responses on the pre-test and 320 (89.9%) on the post-test (p = 0.0233). Folic acid was chosen to be discussed by 74 (47.1%) of 172 participants, and of those, 27 (36.5%) completed the content on this topic, and all 27 (100%) completed the post-test. For the 5 questions about folic acid use, there were 181 (45.3%) correct responses on the pre-test and 111 (71.6%) on the post-test (p < 0.0001). The number of correct responses on the post-test was positively associated with the number of sessions that the participant engaged with Nthabi. Conclusion: The Nthabi conversational agent system increased knowledge of family planning methods and folic acid use among young women in Lesotho. Digital health interventions like Nthabi offer new opportunities to deliver reproductive health information in countries that have limited human resources for health. Trial Registration: ClinicalTrials.gov ID: NCT04354168.

Design and rationale of the mobile health intervention for rural atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) is a highly morbid condition which requires long-term adherence to oral anticoagulation and may be associated with adverse quality of life and health care utilization. We developed a relational agent-an interactive smartphone-based intervention accessible regardless of digital or health literacy-to assist individuals residing in rural, Western Pennsylvania, with AF with chronic disease self-management. METHODS: The "Mobile health intervention for rural atrial fibrillation" is a single center, parallel-arm randomized clinical trial for adults with AF funded by the National Institute of Health's National Heart, Lung, and Blood Institute to enroll 264 participants. All participants receive a smartphone with data plan: The intervention is a 4 month relational agent coupled with the AliveCor Kardia for heart rate and rhythm monitoring provided by smartphone, and the control a pre-installed, smartphone-based application for health-related information (WebMD). The study uses remote recruitment and engagement to enroll individuals who would otherwise be unlikely to participate in clinical research due to rurality. The primary outcome of the trial is adherence to oral anticoagulation, determined by proportion of days covered, as measured at 12 months. The secondary outcomes are quality of life, both AF-specific and general, and health care utilization. The study entails a baseline visit, a 4 month intervention phase, and 8 and 12 month follow-up visits. CONCLUSIONS: This mobile health trial tests the effectiveness of a smartphone-based relational agent to improve clinical and patient-reported outcomes in rural-dwelling individuals.

Designing Empathic Virtual Agents: Manipulating Animation, Voice, Rendering, and Empathy to Create Persuasive Agents.

Designers of virtual agents have a combinatorically large space of choices for the look and behavior of their characters. We conducted two between-subjects studies to explore the systematic manipulation of animation quality, speech quality, rendering style, and simulated empathy, and its impact on perceptions of virtual agents in terms of naturalness, engagement, trust, credibility, and persuasion within a health counseling domain. In the first study, animation was varied between manually created, procedural, or no animations; voice quality was varied between recorded audio and synthetic speech; and rendering style was varied between realistic and toon-shaded. In the second study, simulated empathy of the agent was varied between no empathy, verbal-only empathic responses, and full empathy involving verbal, facial, and immediacy feedback. Results show that natural animations and recorded voice are more appropriate for the agent's general acceptance, trust, credibility, and appropriateness for the task. However, for a brief health counseling task, animation might actually be distracting from the persuasive message, with the highest levels of persuasion found when the amount of agent animation is minimized. Further, consistent and high levels of empathy improve agent perception but may interfere with forming a trusting bond with the agent.

Computerized Relational Agent to Deliver Alcohol Brief Intervention and Referral to Treatment in Primary Care: a Randomized Clinical Trial.

BACKGROUND: Alcohol screening and brief intervention have demonstrated efficacy but limited effectiveness and implementation in real-world primary care settings. OBJECTIVE: To evaluate the effectiveness of a computerized Relational Agent programmed to provide alcohol screening, brief intervention, and referral to treatment. We hypothesized that participants in the experimental condition would report greater reductions in their drinking and higher rates of brief intervention and referrals to specialty care compared to those in treatment as usual (TAU). DESIGN: This was a Hybrid I implementation design and stratified RCT. Participants were randomized to TAU or Relational Agent + TAU and assessed at baseline and 3-month follow-up. PARTICIPANTS: A total of 178 veteran participants were recruited by referral from primary care staff after a positive alcohol screen, or via letter sent do patients screening positive during recent visit. INTERVENTION(S): TAU involved yearly reminders to screen alcohol use and provide brief intervention and treatment referrals, as needed. The Relational Agent added an automated brief intervention, a 1-month follow-up Relational Agent visit, and referral to treatment if needed. MAIN MEASURES: We measured average drinks per day, drinking days per week, number of brief interventions, and number of referrals over 3 months. KEY RESULTS: Participants decreased their drinking in both study conditions, with no significant between-group differences on primary alcohol measures. However, Relational Agent + TAU participants evidenced greater improvements regarding negative alcohol-related consequences over 3 months, and were significantly more likely to receive a brief intervention and referral to specialty care. CONCLUSIONS: The Relational Agent successfully provided brief intervention and referred many more patients to specialty care and was able to intervene with patients with less severe drinking without increasing primary care burden. TRIAL REGISTRATION: clinicaltrials.gov , NCT02030288, https://clinicaltrials.gov/ct2/home.

Mitigating Patient and Consumer Safety Risks When Using Conversational Assistants for Medical Information: Exploratory Mixed Methods Experiment.

BACKGROUND: Prior studies have demonstrated the safety risks when patients and consumers use conversational assistants such as Apple's Siri and Amazon's Alexa for obtaining medical information. OBJECTIVE: The aim of this study is to evaluate two approaches to reducing the likelihood that patients or consumers will act on the potentially harmful medical information they receive from conversational assistants. METHODS: Participants were given medical problems to pose to conversational assistants that had been previously demonstrated to result in potentially harmful recommendations. Each conversational assistant's response was randomly varied to include either a correct or incorrect paraphrase of the query or a disclaimer message-or not-telling the participants that they should not act on the advice without first talking to a physician. The participants were then asked what actions they would take based on their interaction, along with the likelihood of taking the action. The reported actions were recorded and analyzed, and the participants were interviewed at the end of each interaction. RESULTS: A total of 32 participants completed the study, each interacting with 4 conversational assistants. The participants were on average aged 42.44 (SD 14.08) years, 53% (17/32) were women, and 66% (21/32) were college educated. Those participants who heard a correct paraphrase of their query were significantly more likely to state that they would follow the medical advice provided by the conversational assistant (χ21=3.1; P=.04). Those participants who heard a disclaimer message were significantly more likely to say that they would contact a physician or health professional before acting on the medical advice received (χ21=43.5; P=.001). CONCLUSIONS: Designers of conversational systems should consider incorporating both disclaimers and feedback on query understanding in response to user queries for medical advice. Unconstrained natural language input should not be used in systems designed specifically to provide medical advice.

Black Men's Experiences With Health care: Individuals' Accounts of Challenges, Suggestions for Change, and the Potential Utility of Virtual Agent Technology to Assist Black Men With Health Management.

Black men have the highest age-adjusted death rate of any major race-gender group in America. Understanding their perceived barriers to accessing health care may benefit future interventions working to increase Black men's health care engagement. Data collected from focus groups of Black men(N = 67), key informant interviews(N = 12), and interviews(N = 5) with participants who pilot tested an online health education system (called "Gabe") were analyzed to explore their health care experiences and how computer-based health programs might better assist Black men. Concerns pertaining to health care systems' failure to recognize the diversity among Black men, and physicians' lack of sociocultural awareness about the challenges they regularly face, were most salient. Building trust with providers was cited as being central to engagement, with Gabe users perceiving the system to be both trustworthy and accessible. Participants reported an openness to technology assisting with health management and provided suggestions of how online systems can meet the needs of Black men.

Utility of a virtual counselor (VICKY) to collect family health histories among vulnerable patient populations: A randomized controlled trial.

OBJECTIVES: This study is a randomized controlled trial comparing the efficacy of a virtual counselor (VICKY) to the My Family Health Portrait (MFHP) tool for collecting family health history (FHx). METHODS: A total of 279 participants were recruited from a large safety-net hospital and block randomized by health literacy to use one of the digital FHx tools, followed by a genetic counselor interview. A final sample of 273 participants were included for analyses of primary study aims pertaining to tool concordance, which assessed agreement between tool and genetic counselor. RESULTS: Tool completion differed significantly between tools (VICKY = 97%, MFHP = 51%; p < .0001). Concordance between tool and genetic counselor was significantly greater for participants randomized to VICKY compared to MFHP for ascertaining first- and second-degree relatives (ps<.0001), and most health conditions examined. There was significant interaction by health literacy, with greater differences in concordance observed between tools among those with limited literacy. CONCLUSIONS: A virtual counselor overcomes many of the literacy-related barriers to using traditional digital tools and highlights an approach that may be important to consider when collecting health histories from vulnerable populations. PRACTICE IMPLICATIONS: The usability of digital health history tools will have important implications for the quality of the data collected and its downstream clinical utility.

The Perspectives of Women and Their Health-Care Providers Regarding Using an ECA to Support Mode of Birth Decisions.

This study used focus groups to assess the feasibility and acceptability of adapting an Embodied Conversational Agent (ECA) to support decision-making about mode of birth after previous cesarean. Twelve women with previous cesareans, and eight prenatal providers at an academic, tertiary-care medical center, viewed a prototype ECA and were asked to share feedback on the potential role in helping women prepare for decision-making. Both groups felt that although it was somewhat "robot-like," the ECA could provide easy access to information for patients and could augment the visit with providers. Future work is needed to improve ECA visual appeal and clarify the role and timing for utilization of decision aids using ECA technology to enhance the shared decision-making process.

Assessing the potential of a Virtual Patient Advocate to provide preconception care and health advice to women living in Australia.

A preconception Virtual Patient Advocate (VPA) called "Gabby" supported African-American women to decrease their preconception health risks and may be a scalable resource to increase women's access to preconception care. Aims were to assess the acceptability of a preconception VPA in women living in Australia and document the changes required to adapt Gabby to suit an Australian context. Taking a descriptive qualitative approach, nonpregnant female participants (n = 31), aged 18-45 years, living in metropolitan and regional Victoria, Australia interacted with Gabby. Focus groups (n = 7) that gathered participants' perspectives of their experience with Gabby ran in July-August 2019 before being transcribed verbatim and thematically analyzed. Six interrelated themes and 12 subthemes were identified. Participants found VPAs to be an acceptable provider of health information with potential to increase women's access preconception health advice. Gabby was considered to be trustworthy and was able to develop rapport with participants in a relatively short time. Context-specific, relevant, tailored and trustworthy information and advice were considered more important that Gabby's physical appearance. Participants had strong opinions about potential technological advancements (e.g., reminders and rewards) and addressing navigation issues to increase Gabby's acceptability. Participants envisaged that they would use Gabby for readily available and evidence-based information before seeking advice from a health professional if required. Overall, the concept VPAs to provide preconception advice and Gabby were acceptable to participants. Future development of VPAs, Gabby, and other online technology-based resources should consider women's high expectations of the online health information they choose to interact with.

Improving the health of young African American women in the preconception period using health information technology: a randomised controlled trial.

BACKGROUND: Preconception care focuses on improving women's health before pregnancy as a means to improve their health and future pregnancy outcomes. How to effectively deliver such care is unknown. The aim of this research was to assess the impact of an embodied conversational agent system on preconception risks among African American and Black women. METHODS: We did an open-label, randomised controlled trial of women aged 18-34 years, self-identified as African American or Black, or both, and not pregnant, recruited from 35 states in the USA. Sealed allocation envelopes (in permuted blocks of six and eight, prepared using a random number generator) were opened after enrolment. Intervention participants received an online conversational agent called Gabby that assessed 102 preconception risks and delivered 12 months of tailored dialogue using synthesised speech, non-verbal behaviour, visual aids, and health behaviour change techniques such as motivational interviewing. The control group received a letter listing their preconception risks and encouraging them to talk with a clinician. The primary outcome was the proportion of identified risks at the action or maintenance stage of change at months 6 and 12. The study is registered with ClinicalTrials.gov, NCT01827215. FINDINGS: From March 11, 2014, through July 8, 2018, 528 women recruited from 35 states and 242 cities across the USA received the Gabby intervention (n=262) or were assigned to the control group (n=266). Participants identified a mean of 21 preconception risks per woman (SD 9·9). In the intention-to-treat analysis, at 6 months, intervention women reported reaching the action or maintenance stage of change for 50·0% (SD 28·9) of those preconception risks identified compared with 42·7% (28·3) in the control group (incidence rate ratio 1·16, 95% CI 1·07-1·26; p=0·0004). This result persisted at 12 months. INTERPRETATION: The Gabby system has the potential to improve women's preconception health. Further research is needed to determine if improving preconception risks impacts outcomes such as preterm delivery. FUNDING: National Institute for Minority Health and Health Disparities.

Effects of Counseling by Peer Human Advisors vs Computers to Increase Walking in Underserved Populations: The COMPASS Randomized Clinical Trial.

Importance: Effective and practical treatments are needed to increase physical activity among those at heightened risk from inactivity. Walking represents a popular physical activity that can produce a range of desirable health effects, particularly as people age. Objective: To test the hypothesis that counseling by a computer-based virtual advisor is no worse than (ie, noninferior to) counseling by trained human advisors for increasing 12-month walking levels among inactive adults. Design, Setting, and Participants: A cluster-randomized, noninferiority parallel trial enrolled 245 adults between July 21, 2014, and July 29, 2016, with follow-up through September 15, 2017. Data analysis was performed from March 15 to December 20, 2018. The evidence-derived noninferiority margin was 30 minutes of walking per week. Participants included inactive adults aged 50 years and older, primarily of Latin American descent and capable of walking without significant limitations, from 10 community centers in Santa Clara and San Mateo counties, California. Interventions: All participants received similar evidence-based, 12-month physical activity counseling at their local community center, with the 10 centers randomized to a computerized virtual advisor program (virtual) or a previously validated peer advisor program (human). Main Outcomes and Measures: The primary outcome was change in walking minutes per week over 12 months using validated interview assessment corroborated with accelerometry. Both per-protocol and intention-to-treat analysis was performed. Results: Among the 245 participants randomized, 193 were women (78.8%) and 241 participants (98.4%) were Latino. Mean (SD) age was 62.3 (8.4) years (range, 50-87 years), 107 individuals (43.7%) had high school or less educational level, mean BMI was 32.8 (6.8), and mean years residence in the US was 47.4 (17.0) years. A total of 231 participants (94.3%) completed the study. Mean 12-month change in walking was 153.9 min/wk (95% CI, 126.3 min/wk to infinity) for the virtual cohort (n = 123) and 131.9 min/wk (95% CI, 101.4 min/wk to infinity) for the human cohort (n = 122) (difference, 22.0, with lower limit of 1-sided 95% CI, -20.6 to infinity; P = .02); this finding supports noninferiority. Improvements emerged in both arms for relevant clinical risk factors, sedentary behavior, and well-being measures. Conclusions and Relevance: The findings of this study indicate that a virtual advisor using evidence-based strategies produces significant 12-month walking increases for older, lower-income Latino adults that are no worse than the significant improvements achieved by human advisors. Changes produced by both programs are commensurate with those reported in previous investigations of these behavioral interventions and provide support for broadening the range of light-touch physical activity programs that can be offered to a diverse population. Trial Registration: ClinicalTrials.gov Identifier: NCT02111213.

Study protocol for the implementation of the Gabby Preconception Care System - an evidence-based, health information technology intervention for Black and African American women.

BACKGROUND: Improving the health of women before pregnancy and throughout a woman's lifespan could mitigate disparities and improve the health and wellbeing of women, infants and children. The preconception period is important for reducing health risks associated with poor maternal, perinatal and neonatal outcomes, and eliminating racial and ethnic disparities in maternal and child health. Low cost health information technology interventions provided in community-based settings have the potential to reach and reduce disparities in health outcomes for socially disadvantaged, underserved and health disparity populations. These interventions are particularly important for Black and African American women who have a disproportionate burden of pregnancy-related complications and infant mortality rates compared to any other racial and ethnic group in the U.S. METHODS: This is a hybrid type II implementation-effectiveness cohort study aimed at evaluating appropriateness, acceptability and feasibility implementation outcomes, while also systematically examining the clinical effectiveness of a preconception care (PCC) intervention, the Gabby System, for Black and African American women receiving health services in community-based sites. The intervention will be implemented in six Community Health Centers and six Healthy Start programs across the U.S. Each study site will recruit and enroll 25-50 young Black and African American women who will participate in the intervention for a 6-month period. Appropriateness, acceptability and feasibility of implementing the PCC intervention will be assessed using: 1) Qualitative data derived from individual interviews with Gabby System end-users (clients and patients) and site staff; and, 2) Quantitative data from staff surveys, Gabby System usage and uptake. Aggregate health risk and utilization measures collected directly from the Gabby server will be used to examine the effectiveness of the Gabby System on self-reported behavior change. DISCUSSION: This study will examine implementation outcomes and clinical effectiveness of an evidence-based PCC intervention for Black and African American women receiving services in Healthy Start programs and Community Health Centers. Contextual factors that influence uptake and appropriate implementation strategies will be identified to inform future scalability of the intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT04514224 . Date of registration: August 14, 2020. Retrospectively Registered.

The Atrial Fibrillation Health Literacy Information Technology Trial: Pilot Trial of a Mobile Health App for Atrial Fibrillation.

BACKGROUND: Atrial fibrillation (AF) is a common arrhythmia that adversely affects health-related quality of life (HRQoL). We conducted a pilot trial of individuals with AF using a smartphone to provide a relational agent as well as rhythm monitoring. We employed our pilot to measure acceptability and adherence and to assess its effectiveness in improving HRQoL and adherence. OBJECTIVE: This study aims to measure acceptability and adherence and to assess its effectiveness to improve HRQoL and adherence. METHODS: Participants were recruited from ambulatory clinics and randomized to a 30-day intervention or usual care. We collected baseline characteristics and conducted baseline and 30-day assessments of HRQoL using the Atrial Fibrillation Effect on Quality of Life (AFEQT) measure and self-reported adherence to anticoagulation. The intervention consisted of a smartphone-based relational agent, which simulates face-to-face counseling and delivered content on AF education, adherence, and symptom monitoring with prompted rhythm monitoring. We compared differences in AFEQT and adherence at 30 days, adjusted for baseline values. We quantified participants' use and acceptability of the intervention. RESULTS: A total of 120 participants were recruited and randomized (59 to control and 61 to intervention) to the pilot trial (mean age 72.1 years, SD 9.10; 62/120, 51.7% women). The control group had a 95% follow-up, and the intervention group had a 93% follow-up. The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; P=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; P=.009) compared with the control between baseline and 30 days. The intervention group showed significantly improved self-reported adherence to anticoagulation therapy at 30 days (intervention 3.5%; control 23.2%; adjusted difference 16.6%; 95% CI 2.8%-30.4%; P<.001). Qualitative assessments of acceptability identified that participants found the relational agent useful, informative, and trustworthy. CONCLUSIONS: Individuals randomized to a 30-day smartphone intervention with a relational agent and rhythm monitoring showed significant improvement in HRQoL and adherence. Participants had favorable acceptability of the intervention with both objective use and qualitative assessments of acceptability.

Promotion of Preconception Care Among Adolescents and Young Adults by Conversational Agent.

PURPOSE: Preconception care is important for all women to improve infant and maternal health outcomes and may be especially important for adolescents and young adults. This study assesses the acceptance, usability, and use of an automated intervention to screen women on 108 preconception care risks and address them over the course of a year via a Web-based virtual animated health counselor and compares these measures for the adolescent and young adult users aged 18-25 years with those of users aged 26-34 years. We hypothesize that the younger cohort will have significantly greater use of and satisfaction with the online intervention. METHODS: A randomized controlled trial involving a national sample of 528 women was conducted. We present a secondary data analysis on the system use and self-reported usability and satisfaction of the 79 women aged 18-25 years randomized to the intervention group, compared with the 183 women aged 26-34 years in the intervention group. Participants were required to self-identify as female, black or African American, aged 18-34 years, not pregnant, and English-speaking and were recruited through a variety of advertisements and outreach activities. RESULTS: Of the adolescent and young adult participants (aged 18-25 years) enrolled and randomized to the intervention, 20.25% of participants accessed the system 0 times; 29.11%, 1-3 times; and 50.63%, >3 times over the course of a year. At the end of the year, almost all (96.4%) indicated they had either acted on recommendations made by the agent or planned to. Most (75.0%) said they would recommend the system to someone they knew. There were no significant differences between the two age groups on intervention use or satisfaction. CONCLUSIONS: Web-based conversational agents are a viable medium for delivering longitudinal preconception care counseling to adolescents and young adults.