BACKGROUND: Hypertension affects one-third of adults in the United States and is the leading risk factor for death. Underserved populations are seen disproportionately in the emergency department (ED) and tend to have worse blood pressure (BP) control. For adults, a lack of hypertension knowledge is a common barrier to hypertension control, while social support is a strong facilitator, and providing information that is culturally sensitive and relevant is especially important in this context. The youth experience increased confidence when given the responsibility to provide health education and care navigation to others. As such, we planned a randomized controlled trial (RCT) for the effectiveness of a digital youth-led hypertension education intervention for adult patients in the ED with hypertension, focusing on change in BP and hypertension knowledge.
OBJECTIVE: In preparation for an RCT, we conducted a formative study to determine acceptable and easily comprehensible ways to present hypertension information to adults with hypertension and optimal ways to engage youth to support adults on how to achieve better hypertension control.
METHODS: After creating an intervention prototype with 6 weekly self-guided hypertension online modules, we recruited 12 youth (adolescents, aged 15-18 years) for 3 focus groups and 10 adult ED patients with hypertension for individual online interviews to garner feedback on the prototype. After completing a brief questionnaire, participants were asked about experiences with hypertension, preferences for a hypertension education intervention, and acceptability, feasibility, obstacles, and solutions for intervention implementation with youth and adults. The moderator described and showed participants the prototyped intervention process and materials and asked for feedback. Questionnaire data were descriptively summarized, and qualitative data were analyzed using the template organizing style of analysis by 3 study team members.
RESULTS: Participants showed great interest in the intervention prototype, thought their peers would find it acceptable, and appreciated its involvement of youth. Youth with family members with hypertension reported that their family members need more support for their hypertension. Youth suggested adding more nutrition education activities to the intervention, such as a sodium tracker and examples of high-sodium foods. Adults discussed the need for a hypertension support intervention for themselves and the expected benefits to youth. They mentioned the overwhelming amount of hypertension information available and appreciated the intervention\'s concise content presentation. They suggested adding more mental health and smoking cessation resources, information about specific hypertension medications, and adding active links for health care information.
CONCLUSIONS: Based on focus groups and interviews with participants, a youth-led digital hypertension intervention is an acceptable strategy to engage both adults with hypertension and youth. Incorporating participant suggestions into the intervention may improve its clarity, engagement, and impact when used in a subsequent RCT.

BACKGROUND: Low physical activity among older adults is related to adverse health outcomes such as depression and loneliness, poor physical function and increased risk of falls. This study was designed to increase physical activity through a digital, group-based, physical activity and music intervention and to examine its effectiveness on social, mental and physical health outcomes.
METHODS: Participants were 34 older adults (65 years +) recruited across four care homes in Scotland to a pilot study. Surveys were administered at baseline and post-intervention, comprising measures of fear of falling, depression and anxiety, loneliness, sleep satisfaction and quality of life. A battery of physical function tests and saliva sampling for cortisol and dehydroepiandrosterone hormone analysis were also conducted at each time point. Additionally, process evaluation measures (recruitment, intervention fidelity, attendance, retention rates and safety) were monitored. The intervention comprised 12 weeks of three prescribed digital sessions per week: movement and music (n = 2) and music-only (n = 1), delivered by an activity coordinator in the care home. Post-intervention interviews with staff and participants were conducted to gain qualitative data on the acceptability of the intervention.
RESULTS: An average of 88% of prescribed sessions were delivered. Pre- to post-intervention intention-to-treat analysis across all participants revealed significant improvements in anxiety, salivary DHEA, fear of falling and loneliness. There were no significant improvements in health-related quality of life, perceived stress, sleep satisfaction or physical function tests, including handgrip strength. Qualitative analysis highlighted benefits of and barriers to the programme.
CONCLUSIONS: The digital movement and music intervention was deemed acceptable and delivered with moderate fidelity, justifying progression to a full-scale trial. Although a proper control group would have yielded more confident causal relationships, preliminary psychosocial and biological effects were evident from this trial. To show significant improvements in physical function, it is likely that a bigger sample size providing sufficient power to detect significant changes, greater adherence, longer intervention and/or higher exercise volume may be necessary.
BACKGROUND: The trial is registered at ClinicalTrials.gov, number NCT05601102 on 01/11/2022.

Medication reconciliation, the process of documenting a patient\'s medication, is currently a time-consuming and labor-intensive process. To make medication reconciliation more efficient, digital assistants (DAs) offer a promising solution. Especially since human-like digital interfaces tend to be appreciated by more vulnerable populations such as patients in a low socioeconomic position (SEP). Despite the potential of DAs for low-SEP populations in particular, these groups are often not involved during the development and design phase of such digital health interventions. This exclusion may explain the lower adoption rates of digital interventions among low-SEP patients and exacerbate the so-called digital divide. We explored the perceptions and needs of patients across the SEP gradient using a participatory design approach. Patients of low-, middle-, and high-SEP backgrounds were asked to interact with a DA developed for this study and were interviewed afterward. A thematic analysis revealed seven themes regarding design, input method, comprehensibility, privacy concerns, benefits, the intention to use, and reassurance. Overall, patients were afraid to make mistakes in their medication entries and therefore valued feedback from the system or caregivers. Low-SEP patients specifically seemed to value more structured input methods when using the DA, while high-SEP patients emphasized the importance of a secure environment for the DA and sought clarity about its functionalities. Our study demonstrates the importance of involving patients across the socioeconomic gradient when developing a digital health tool and offers concrete recommendations for inclusive DA design for researchers and developers.

UNASSIGNED: Physical inactivity is associated with health risks, contributing to various diseases and all-cause mortality. Despite recommendations for regular physical activity (PA), many adults remain inactive, influenced by socioeconomic and environmental factors. Digital interventions, particularly web-based PA programs, offer promising possibilities to promote PA across populations. These programs vary in their effectiveness, reflecting differences in design, user engagement, and behavior change techniques employed.
UNASSIGNED: This study evaluates the effectiveness of the 12-week multimodal web-based TKFitnessCoach. The PA online program is part of the TK-HealthCoach. This study investigates the program\'s impact on self-reported PA levels, goal attainment, healthrelated quality of life, body weight, and eating behavior, comparing an interactive personalized web-based intervention and non-interactive web-based health information.
UNASSIGNED: In a randomized controlled trial (RCT), participants were allocated to either the intervention group (IG), receiving access to the interactive TK-FitnessCoach, or the control group (CG) that was provided a static website with evidence-based information on PA. The study targeted a German-speaking adult population interested in improving health behavior. Data was assessed at T0 (beginning of the study), T1 (postintervention), T2, 6 months, and T3, 12 months follow-ups, focusing on self-reported PA at T3 and on various secondary outcomes.
UNASSIGNED: We achieved equally distributed sociodemographics in both the IG and the CG with a mean age of 42.8 (IG), resp. 43.1 years (CG), and female participants of 76.1 % (IG), resp. 74.7 % (CG). PA at baseline was 277.9 min/week in the IG and 273.3 min/week in the CG. Both, the IG (n = 1153 in the Intention-to-treat (ITT) dataset) and CG (n = 1177 in the ITT dataset) exhibited significant increases in PA over time (IG(T3-T0) = 72.92 min/week; CG(T3-T0) = 74.12 min/week).However, the study did not find significant differences in the effectiveness of the interactive TK-FitnessCoach compared to the non-interactive control in terms of improving PA and related health outcomes. The intensity of using the TK-FitnessCoach was not associated with PA.
UNASSIGNED: Both programs were effective in promoting PA among adults, with no significant differences observed between the two RCT groups. This highlights the potential of digital interventions in addressing physical inactivity, suggesting that the effectiveness of such programs may not solely depend on their interactivity but also on the quality and relevance of the information provided. Further research is needed to explore optimization strategies for such interventions, especially for persons with low PA, including user engagement, behavior change techniques, and the integration of objective PA tracking methods.
UNASSIGNED: German Clinical Trials Register DRKS00020249; https://drks.de/search/en/trial/DRKS00020249.

BACKGROUND: Profound scientific evaluation of novel digital health technologies (DHTs) is key to enhance successful development and implementation. As such, we previously developed the eHealth evaluation cycle. The eHealth evaluation cycle contains 5 consecutive study phases: conceptual, development, feasibility, effectiveness, and implementation.
OBJECTIVE: The aim of this study is to develop a better understanding of the daily practice of the eHealth evaluation cycle. Therefore, the objectives are to conduct a structured analysis of literature data to analyze the practice of the evaluation study phases and to determine which evaluation approaches are used in which study phase of the eHealth evaluation cycle.
METHODS: We conducted a systematic literature search in PubMed including the MeSH term \"telemedicine\" in combination with a wide variety of evaluation approaches. Original peer-reviewed studies published in the year 2019 (pre-COVID-19 cohort) were included. Nonpatient-focused studies were excluded. Data on the following variables were extracted and systematically analyzed: journal, country, publication date, medical specialty, primary user, functionality, evaluation study phases, and evaluation approach. RStudio software was used to summarize the descriptive data and to perform statistical analyses.
RESULTS: We included 824 studies after 1583 titles and abstracts were screened. The majority of the evaluation studies focused on the effectiveness (impact; 304/824, 36.9%) study phase, whereas uptake (implementation; 70/824, 8.5%) received the least focus. Randomized controlled trials (RCTs; 170/899, 18.9%) were the most commonly used DHT evaluation method. Within the effectiveness (impact) study phase, RCTs were used in one-half of the studies. In the conceptual and planning phases, survey research (27/78, 35%) and interview studies (27/78, 35%) were most frequently used. The United States published the largest amount of DHT evaluation studies (304/824, 36.9%). Psychiatry and mental health (89/840, 10.6%) and cardiology (75/840, 8.9%) had the majority of studies published within the field.
CONCLUSIONS: We composed the first comprehensive overview of the actual practice of implementing consecutive DHT evaluation study phases. We found that the study phases of the eHealth evaluation cycle are unequally studied and most attention is paid to the effectiveness study phase. In addition, the majority of the studies used an RCT design. However, in order to successfully develop and implement novel DHTs, stimulating equal evaluation of the sequential study phases of DHTs and selecting the right evaluation approach that fits the iterative nature of technology might be of the utmost importance.

BACKGROUND: Despite being the primary setting for HIV prevention among men who have sex with men (MSM) since the start of the epidemic, community-based organizations (CBOs) struggle to reach this historically stigmatized and largely hidden population with face-to-face interventions. HIV researchers have readily turned to the internet to deliver critical HIV education to this group, with evidence of high effectiveness and acceptability across studies. However, implementation outside of research contexts has been limited and not well studied. We aimed to assess HIV CBOs\' readiness to adopt digital health interventions and identify contextual factors that may contribute to differing levels of readiness.
METHODS: We recruited 22 CBOs across the US through a pragmatic request-for-proposals process to deliver Keep It Up! (KIU!), an evidence-based eHealth HIV prevention program. We used mixed methods to examine CBO readiness to adopt digital health interventions (RADHI). Before implementation, CBO staff completed a 5-item RADHI scale (scored 0-4) that demonstrated concurrent and predictive validity. We interviewed CBO staff using semi-structured questions guided by the Consolidated Framework for Implementation Research and compared RADHI score groups on determinants identified from the interviews.
RESULTS: Eighty-five staff (range = 1-10 per CBO) completed the RADHI. On average, CBOs reported moderate-to-great readiness (2.74) to adopt KIU!. High RADHI CBOs thought KIU! was a top priority and an innovative program complementary to their existing approaches for their clients. Low RADHI CBOs expressed concerns that KIU! could be a cultural mismatch for their clients, was lower priority than existing programs and services, relied on clients\' own motivation, and might not be suitable for clients with disabilities. Value, appeal, and limitations did not differ by RADHI group.
CONCLUSIONS: While HIV CBOs are excited for the opportunities and advantages of digital interventions, additional pre-implementation and implementation support may be needed to increase perceived value and usability for different client populations. Addressing these limitations is critical to effective digital prevention interventions for HIV and other domains such as mental health, chronic disease management, and transitions in care. Future research can utilize our novel, validated measure of CBOs\' readiness to adopt digital health interventions.
BACKGROUND: NCT03896776, clinicaltrials.gov, 1 April 2019.

BACKGROUND: The design and development of patient-centered digital health solutions requires user involvement, for example through usability testing. Although there are guidelines for conducting usability tests, there is a lack of knowledge about the technical, human, and organizational factors that influence the success of the tests.
OBJECTIVE: To summarize the success factors of usability testing in the context of patient-centered digital health solutions.
METHODS: We considered three case studies and collected experiences related to time management, relevance of results and challenges encountered.
RESULTS: Success factors relate to participant privacy and data protection, test environment setup, device and application readiness, user comfort and accessibility, test tools and procedures, and adaptability to user limitations.
CONCLUSIONS: Small organizational and technical details can have a big impact on the outcome of a usability test. Considering the aspects mentioned in this paper will not only save resources but also the trust of the participating patients.

BACKGROUND: Advanced cancer significantly impacts patients\' and family caregivers\' quality of life. When patients and caregivers are supported concurrently as a dyad, the well-being of each person is optimized. Family, Outlook, Communication, Uncertainty, Symptom management (FOCUS) is a dyadic, psychoeducational intervention developed in the United States, shown to improve the well-being and quality of life of patients with advanced cancer and their primary caregivers. Originally, a nurse-delivered in-person intervention, FOCUS has been adapted into a self-administered web-based intervention for European delivery.
OBJECTIVE: The aims of this study are to (1) adapt FOCUS to the Australian context (FOCUSau); (2) evaluate the effectiveness of FOCUSau in improving the emotional well-being and self-efficacy of patients with advanced cancer and their primary caregiver relative to usual care control group; (3) compare health care use between the intervention and control groups; and (4) assess the acceptability, feasibility, and scalability of FOCUSau in order to inform future maintainable implementation of the intervention within the Australian health care system.
METHODS: FOCUS will be adapted prior to trial commencement, using an iterative stakeholder feedback process to create FOCUSau. To examine the efficacy and cost-effectiveness of FOCUSau and assess its acceptability, feasibility, and scalability, we will undertake a hybrid type 1 implementation study consisting of a phase 3 (clinical effectiveness) trial along with an observational implementation study. Participants will include patients with cancer who are older than 18 years, able to access the internet, and able to identify a primary support person or caregiver who can also be approached for participation. The sample size consists of 173 dyads in each arm (ie, 346 dyads in total). Patient-caregiver dyad data will be collected at 3 time points-baseline (T0) completed prerandomization; first follow-up (T1; N=346) at 12 weeks post baseline; and second follow-up (T2) at 24 weeks post baseline.
RESULTS: The study was funded in March 2022. Recruitment commenced in July 2024.
CONCLUSIONS: If shown to be effective, this intervention will improve the well-being of patients with advanced cancer and their family caregivers, regardless of their location or current level of health care support.
BACKGROUND: ClinicalTrials.gov NCT06082128; https://clinicaltrials.gov/study/NCT06082128.
UNASSIGNED: PRR1-10.2196/55252.

BACKGROUND: Cardiometabolic diseases (CMDs) are a group of interrelated conditions, including heart failure and diabetes, that increase the risk of cardiovascular and metabolic complications. The rising number of Australians with CMDs has necessitated new strategies for those managing these conditions, such as digital health interventions. The effectiveness of digital health interventions in supporting people with CMDs is dependent on the extent to which users engage with the tools. Augmenting digital health interventions with conversational agents, technologies that interact with people using natural language, may enhance engagement because of their human-like attributes. To date, no systematic review has compiled evidence on how design features influence the engagement of conversational agent-enabled interventions supporting people with CMDs. This review seeks to address this gap, thereby guiding developers in creating more engaging and effective tools for CMD management.
OBJECTIVE: The aim of this systematic review is to synthesize evidence pertaining to conversational agent-enabled intervention design features and their impacts on the engagement of people managing CMD.
METHODS: The review is conducted in accordance with the Cochrane Handbook for Systematic Reviews of Interventions and reported in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Searches will be conducted in the Ovid (Medline), Web of Science, and Scopus databases, which will be run again prior to manuscript submission. Inclusion criteria will consist of primary research studies reporting on conversational agent-enabled interventions, including measures of engagement, in adults with CMD. Data extraction will seek to capture the perspectives of people with CMD on the use of conversational agent-enabled interventions. Joanna Briggs Institute critical appraisal tools will be used to evaluate the overall quality of evidence collected.
RESULTS: This review was initiated in May 2023 and was registered with the International Prospective Register of Systematic Reviews (PROSPERO) in June 2023, prior to title and abstract screening. Full-text screening of articles was completed in July 2023 and data extraction began August 2023. Final searches were conducted in April 2024 prior to finalizing the review and the manuscript was submitted for peer review in July 2024.
CONCLUSIONS: This review will synthesize diverse observations pertaining to conversational agent-enabled intervention design features and their impacts on engagement among people with CMDs. These observations can be used to guide the development of more engaging conversational agent-enabled interventions, thereby increasing the likelihood of regular intervention use and improved CMD health outcomes. Additionally, this review will identify gaps in the literature in terms of how engagement is reported, thereby highlighting areas for future exploration and supporting researchers in advancing the understanding of conversational agent-enabled interventions.
BACKGROUND: PROSPERO CRD42023431579; https://tinyurl.com/55cxkm26.
UNASSIGNED: DERR1-10.2196/52973.

BACKGROUND: Limited guidance exists for analyzing participant engagement in provider-guided digital health interventions (DHIs). System usage is commonly assessed, with acknowledged limitations in measuring socio-affective and cognitive aspects of engagement. Nurse WRITE, an 8-week web-based nurse-guided DHI for managing symptoms among women with recurrent ovarian cancer, offers an opportunity to develop a framework for assessing multidimensional engagement.
OBJECTIVE: This study aims to develop a conceptual and analytic framework to measure socio-affective, cognitive, and behavioral engagement with provider-guided DHIs. We then illustrate the framework\'s ability to describe and categorize engagement using Nurse WRITE as an example.
METHODS: A sample of 68 participants from Nurse WRITE who posted on the message boards were included. We adapted a prior framework for conceptualizing and operationalizing engagement across 3 dimensions and finalized a set of 6 distinct measures. Using patients\' posts, we created 2 socio-affective engagement measures-total count of socio-affective engagement classes (eg, sharing personal experience) and total word count-and 2 cognitive engagement measures-total count of cognitive engagement classes (eg, asking information-seeking questions) and average question completion percentage. Additionally, we devised behavioral engagement measures using website data-the total count of symptom care plans and plan reviews. k-Means clustering categorized the participants into distinct groups based on levels of engagement across 3 dimensions. Descriptive statistics and narratives were used to describe engagement in 3 dimensions.
RESULTS: On average, participants displayed socio-affective engagement 34.7 times, writing 14,851 words. They showed cognitive engagement 19.4 times, with an average of 78.3% completion of nurses\' inquiries. Participants also submitted an average of 1.6 symptom care plans and 0.7 plan reviews. Participants were clustered into high (n=13), moderate (n=17), and low engagers (n=38) based on the 6 measures. High engagers wrote a median of 36,956 (IQR 26,199-46,265) words. They demonstrated socio-affective engagement approximately 81 times and cognitive engagement around 46 times, approximately 6 times that of the low engagers and twice that of the moderate engagers. High engagers had a median of 91.7% (IQR 82.2%-93.7%) completion of the nurses\' queries, whereas moderate engagers had 86.4% (IQR 80%-96.4%), and low engagers had 68.3% (IQR 60.1%-79.6%). High engagers completed a median of 3 symptom care plans and 2 reviews, while moderate engagers completed 2 plans and 1 review. Low engagers completed a median of 1 plan with no reviews.
CONCLUSIONS: This study developed and reported an engagement framework to guide behavioral intervention scientists in understanding and analyzing participants\' engagement with provider-guided DHIs. Significant variations in engagement levels across 3 dimensions highlight the importance of measuring engagement with provider-guided DHIs in socio-affective, cognitive, and behavioral dimensions. Future studies should validate the framework with other DHIs, explore the influence of patient and provider factors on engagement, and investigate how engagement influences intervention efficacy.