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.

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.

Acceptability of an Interactive Computer-Animated Agent to Promote Patient-Provider Communication About Breast Density: a Mixed Method Pilot Study.

BACKGROUND: Half of women undergoing mammography have dense breasts. Mandatory dense breast notification and educational materials have been shown to confuse women, rather than empower them. OBJECTIVE: This study used a mixed method, multi-stakeholder approach to assess acceptability of an interactive, computer-animated agent that provided breast density information to women and changes in knowledge, satisfaction, and informational needs. DESIGN: A pre-post survey and qualitative focus groups assessed the acceptability of the computer-animated agent among women. An anonymous, online survey measuring acceptability was delivered to a multi-stakeholder group. PARTICIPANTS: English-speaking, mammography-eligible women ages 40-74 were invited and 44 women participated in one of nine focus groups. In addition, 14 stakeholders representing primary care, radiology, patient advocates, public health practitioners, and researchers completed the online survey. INTERVENTIONS: A prototype of a computer-animated agent was delivered to women in a group setting; stakeholders viewed the prototype independently. MAIN MEASURES: Data collected included open-ended qualitative questions that guided discussion about the content and form of the computer-animated agent. Structured surveys included domains related to knowledge, acceptability, and satisfaction. Stakeholder acceptability was measured with a series of statements about aspects of the intervention and delivery approach and are reported as the proportion of respondents who endorsed each statement. KEY RESULTS: Six of 12 knowledge items demonstrated improvement post-intervention, satisfaction with the agent was high (81%), but the number of unanswered questions did not improve (67% vs. 54%, p = 0.37). Understanding of the distinction between connective and fatty tissue in the breast did not increase (30% vs. 26%, p = 0.48). Results of the multi-stakeholder survey suggest broad acceptability of the approach and agent. CONCLUSIONS: Findings highlight the benefits of a brief interactive educational exposure as well as misperceptions that persisted. Results demonstrate the need for an evidence-based, accessible intervention that is easy to understand for patients.

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.

Patient and Consumer Safety Risks When Using Conversational Assistants for Medical Information: An Observational Study of Siri, Alexa, and Google Assistant.

BACKGROUND: Conversational assistants, such as Siri, Alexa, and Google Assistant, are ubiquitous and are beginning to be used as portals for medical services. However, the potential safety issues of using conversational assistants for medical information by patients and consumers are not understood. OBJECTIVE: To determine the prevalence and nature of the harm that could result from patients or consumers using conversational assistants for medical information. METHODS: Participants were given medical problems to pose to Siri, Alexa, or Google Assistant, and asked to determine an action to take based on information from the system. Assignment of tasks and systems were randomized across participants, and participants queried the conversational assistants in their own words, making as many attempts as needed until they either reported an action to take or gave up. Participant-reported actions for each medical task were rated for patient harm using an Agency for Healthcare Research and Quality harm scale. RESULTS: Fifty-four subjects completed the study with a mean age of 42 years (SD 18). Twenty-nine (54%) were female, 31 (57%) Caucasian, and 26 (50%) were college educated. Only 8 (15%) reported using a conversational assistant regularly, while 22 (41%) had never used one, and 24 (44%) had tried one "a few times." Forty-four (82%) used computers regularly. Subjects were only able to complete 168 (43%) of their 394 tasks. Of these, 49 (29%) reported actions that could have resulted in some degree of patient harm, including 27 (16%) that could have resulted in death. CONCLUSIONS: Reliance on conversational assistants for actionable medical information represents a safety risk for patients and consumers. Patients should be cautioned to not use these technologies for answers to medical questions they intend to act on without further consultation from a health care provider.

Using Relational Agents to Promote Exercise and Sun Protection: Assessment of Participants' Experiences With Two Interventions.

BACKGROUND: Relational agents (RAs) are electronic computational figures designed to engage participants in the change process. A recent study, Project RAISE, tested the effectiveness of RAs, combined with existing computer-based interventions to increase regular exercise and sun protection behaviors. Results showed these interventions can be effective but need further development. OBJECTIVE: The purpose of this study was to examine participants' experiences using RAs to increase participant engagement and promote behavior change . METHODS: A qualitative approach was primarily utilized. A 25-question interview guide assessed different components of participants' experiences with the intervention, including motivation, engagement, satisfaction or dissatisfaction, quality of their interaction with the RA, and behavior change. Quantitative assessment of satisfaction was based on a scale of 1 to 10, with 1 representing least satisfied and 10 representing most satisfied. A summative analytic approach was used to assess individuals' qualitative responses. A single analysis of variance (ANOVA) examined levels of satisfaction by gender. RESULTS: Of the original 1354 participants enrolled in Project RAISE, 490 of 1354 (36%) were assigned to the RA group. A sample of 216 out of 490 (44%) participants assigned to the RA group completed the interventions, and follow-up assessments were contacted to participate in the semistructured interview. A total of 34 out of 216 (16%) completed the interview. Participants were motivated by, and satisfied with, the intervention. Participants viewed the RA as supportive, informative, caring, and reported positive behavior change in both exercise and sun protection. Some participants (15/34, 44%) noted the RA was less judgmental and less "overbearing" compared with a human counselor; other participants (12/34, 35%) said that the interaction was sometimes repetitive or overly general. The majority of participants (22/34, 65%) viewed the RA as an important contributor to their behavior change for exercise, sun protection, or both. Levels of satisfaction ranged between 7 and 10. There were no gender differences noted in levels of satisfaction (P=.51). CONCLUSIONS: RAs provide an innovative and attractive platform to increase exercise and sun protection behaviors and potentially other health behaviors.

Improving Access to Online Health Information With Conversational Agents: A Randomized Controlled Experiment.

BACKGROUND: Conventional Web-based search engines may be unusable by individuals with low health literacy for finding health-related information, thus precluding their use by this population. OBJECTIVE: We describe a conversational search engine interface designed to allow individuals with low health and computer literacy identify and learn about clinical trials on the Internet. METHODS: A randomized trial involving 89 participants compared the conversational search engine interface (n=43) to the existing conventional keyword- and facet-based search engine interface (n=46) for the National Cancer Institute Clinical Trials database. Each participant performed 2 tasks: finding a clinical trial for themselves and finding a trial that met prespecified criteria. RESULTS: Results indicated that all participants were more satisfied with the conversational interface based on 7-point self-reported satisfaction ratings (task 1: mean 4.9, SD 1.8 vs mean 3.2, SD 1.8, P<.001; task 2: mean 4.8, SD 1.9 vs mean 3.2, SD 1.7, P<.001) compared to the conventional Web form-based interface. All participants also rated the trials they found as better meeting their search criteria, based on 7-point self-reported scales (task 1: mean 3.7, SD 1.6 vs mean 2.7, SD 1.8, P=.01; task 2: mean 4.8, SD 1.7 vs mean 3.4, SD 1.9, P<.01). Participants with low health literacy failed to find any trials that satisfied the prespecified criteria for task 2 using the conventional search engine interface, whereas 36% (5/14) were successful at this task using the conversational interface (P=.05). CONCLUSIONS: Conversational agents can be used to improve accessibility to Web-based searches in general and clinical trials in particular, and can help decrease recruitment bias against disadvantaged populations.

Acceptability and feasibility of a virtual counselor (VICKY) to collect family health histories.

PURPOSE: To overcome literacy-related barriers in the collection of electronic family health histories, we developed an animated Virtual Counselor for Knowing your Family History, or VICKY. This study examined the acceptability and accuracy of using VICKY to collect family histories from underserved patients as compared with My Family Health Portrait (MFHP). METHODS: Participants were recruited from a patient registry at a safety net hospital and randomized to use either VICKY or MFHP. Accuracy was determined by comparing tool-collected histories with those obtained by a genetic counselor. RESULTS: A total of 70 participants completed this study. Participants rated VICKY as easy to use (91%) and easy to follow (92%), would recommend VICKY to others (83%), and were highly satisfied (77%). VICKY identified 86% of first-degree relatives and 42% of second-degree relatives; combined accuracy was 55%. As compared with MFHP, VICKY identified a greater number of health conditions overall (49% with VICKY vs. 31% with MFHP; incidence rate ratio (IRR): 1.59; 95% confidence interval (95% CI): 1.13-2.25; P = 0.008), in particular, hypertension (47 vs. 15%; IRR: 3.18; 95% CI: 1.66-6.10; P = 0.001) and type 2 diabetes (54 vs. 22%; IRR: 2.47; 95% CI: 1.33-4.60; P = 0.004). CONCLUSION: These results demonstrate that technological support for documenting family history risks can be highly accepted, feasible, and effective.

Health literacy and usability of clinical trial search engines.

Several web-based search engines have been developed to assist individuals to find clinical trials for which they may be interested in volunteering. However, these search engines may be difficult for individuals with low health and computer literacy to navigate. The authors present findings from a usability evaluation of clinical trial search tools with 41 participants across the health and computer literacy spectrum. The study consisted of 3 parts: (a) a usability study of an existing web-based clinical trial search tool; (b) a usability study of a keyword-based clinical trial search tool; and (c) an exploratory study investigating users' information needs when deciding among 2 or more candidate clinical trials. From the first 2 studies, the authors found that users with low health literacy have difficulty forming queries using keywords and have significantly more difficulty using a standard web-based clinical trial search tool compared with users with adequate health literacy. From the third study, the authors identified the search factors most important to individuals searching for clinical trials and how these varied by health literacy level.

Automated indexing of Internet stories for health behavior change: weight loss attitude pilot study.

BACKGROUND: Automated health behavior change interventions show promise, but suffer from high attrition and disuse. The Internet abounds with thousands of personal narrative accounts of health behavior change that could not only provide useful information and motivation for others who are also trying to change, but an endless source of novel, entertaining stories that may keep participants more engaged than messages authored by interventionists. OBJECTIVE: Given a collection of relevant personal health behavior change stories gathered from the Internet, the aim of this study was to develop and evaluate an automated indexing algorithm that could select the best possible story to provide to a user to have the greatest possible impact on their attitudes toward changing a targeted health behavior, in this case weight loss. METHODS: An indexing algorithm was developed using features informed by theories from behavioral medicine together with text classification and machine learning techniques. The algorithm was trained using a crowdsourced dataset, then evaluated in a 2×2 between-subjects randomized pilot study. One factor compared the effects of participants reading 2 indexed stories vs 2 randomly selected stories, whereas the second factor compared the medium used to tell the stories: text or animated conversational agent. Outcome measures included changes in self-efficacy and decisional balance for weight loss before and after the stories were read. RESULTS: Participants were recruited from a crowdsourcing website (N=103; 53.4%, 55/103 female; mean age 35, SD 10.8 years; 65.0%, 67/103 precontemplation; 19.4%, 20/103 contemplation for weight loss). Participants who read indexed stories exhibited a significantly greater increase in self-efficacy for weight loss compared to the control group (F1,107=5.5, P=.02). There were no significant effects of indexing on change in decisional balance (F1,97=0.05, P=.83) and no significant effects of medium on change in self-efficacy (F1,107=0.04, P=.84) or decisional balance (F1,97=0.78, P=.38). CONCLUSIONS: Personal stories of health behavior change can be harvested from the Internet and used directly and automatically in interventions to affect participant attitudes, such as self-efficacy for changing behavior. Such approaches have the potential to provide highly tailored interventions that maximize engagement and retention with minimal intervention development effort.

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.

Use of an interactive computer agent to support breastfeeding.

Mothers need consistent, sustained information and support to develop and meet personal breastfeeding goals, but often receive insufficient assistance and conflicting and incorrect advice. The use of technology may be helpful in supplementing existing health care professional breastfeeding education and support efforts. We developed and evaluated a computer-based animated, interactive agent designed to provide breastfeeding information and support to mothers interested in breastfeeding. A randomized controlled study of a first-generation system was conducted to determine the feasibility of (1) use of the Computer Agent; (2) the recruitment plan; and (3) the planned outcome evaluation (assessing the impact of the intervention on intent to breastfeed, attitudes towards breastfeeding, and breastfeeding self-efficacy). The pilot study (N = 15) showed that the use of the Computer Agent, the recruitment plan, and the planned outcome evaluation were all feasible. Mothers who used the Computer Agent had greater intentions to exclusively breastfeed after exposure to the Agent (intent to exclusively breastfeed for 6 months 1-7 scale score of 6.14 (post) vs. 5.14 (pre); p < 0.05). Non-statistically significant trends in improvement with use of the Computer Agent breastfeeding support system were also seen in the between subjects analyses of intent to breastfeed and breastfeeding self-efficacy. The pilot study demonstrated the feasibility of using a Computer Agent to support breastfeeding mothers and informed the design of a larger randomized clinical trial. An interactive Computer Agent may be helpful in improving rates of exclusive breastfeeding, particularly when there is not adequate health care professional support.

Employing virtual advisors in preventive care for underserved communities: results from the COMPASS study.

Electronically delivered health promotion programs that are aimed primarily at educated, health-literate individuals have proliferated, raising concerns that such trends could exacerbate health disparities in the United States and elsewhere. The efficacy of a culturally and linguistically adapted virtual advisor that provides tailored physical activity advice and support was tested in low-income older adults. Forty inactive adults (92.5% Latino) 55 years of age and older were randomized to a 4-month virtual advisor walking intervention or a waitlist control. Four-month increases in reported minutes of walking/week were greater in the virtual advisor arm (mean increase = 253.5 ± 248.7 minutes/week) relative to the control (mean increase = 26.8 ± 67.0 minutes/week; p = .0008). Walking increases in the virtual advisor arm were substantiated via objectively measured daily steps (slope analysis p = .002). All but one intervention participant continued some interaction with the virtual advisor in the 20-week poststudy period (mean number of poststudy sessions = 14.0 ± 20.5). The results indicate that a virtual advisor delivering culturally and linguistically adapted physical activity advice led to meaningful 4-month increases in walking relative to control among underserved older adults. This interactive technology, which requires minimal language and computer literacy, may help reduce health disparities by ensuring that all groups benefit from e-health opportunities.

Limited health literacy and decline in executive function in older adults.

Limited health literacy is associated with worse executive function, but the association between limited health literacy and decline in executive function has not been established because of a lack of longitudinal studies. The authors aimed to examine this association by studying a prospective cohort in the setting of a randomized controlled trial to promote walking in older adults. Participants were community-dwelling older adults (65 years of age or older) who scored 2 or more on the Mini-Cog, without depression (score of less than 15 on the 9-item Patient Health Questionnaire), and who completed baseline and 12-month evaluations (n = 226). Health literacy was measured using the Short Test of Functional Health Literacy in Adults. Executive function measured at baseline and 12 months using the Trail Making Test (TMT), Controlled Oral Word Association Test, and Category Fluency. The associations between health literacy and 12-month decline in each test of executive function were modeled using multivariate linear regression. Health literacy was found to be limited in 37% of participants. Limited health literacy was associated with reduced performance on all 3 executive function tests. In fully adjusted models, limited health literacy was associated with greater 12-month decline in performance on the TMT than higher health literacy (p = .01). In conclusion, older adults with limited health literacy are at risk for more rapid decline in scores on the TMT, a measure of executive function.

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.

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, 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).

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.