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: 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: 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.

BACKGROUND: The use of digital Patient- Reported Outcomes (PRO) tools has been shown to enhance the exchange of information and shared decision-making in medical encounters. However, their influence on patient-pharmacist interactions has not yet been explored.
OBJECTIVE: This study aimed to examine the impact of RxTalk™, a digital PRO tool, in supporting the communication between patients and pharmacists compared to usual care.
METHODS: Intervention: RxTalk™ was developed to collect information about medication adherence and beliefs, using a tablet computer.
METHODS: A pilot randomized controlled study was conducted at a community pharmacy in Wisconsin, USA. Sixty patients were randomized to either the intervention group who used RxTalk™ during medication pick-up or the control group who did not use the tool. Patients who used RxTalk™ received paper copies of their responses which were also shared with pharmacists. The consultation was audio-recorded for both groups and coded using the Active Patient Participation Coding scale. Follow-up phone interviews were conducted with both groups within one week of enrollment.
RESULTS: Patient tapes were analyzed. In the unadjusted model, patients in the intervention group had a higher active participation rate (p = 0.004) and raised significantly more concerns during consultations (p < 0.001) compared to the control group. Pharmacists asked twice as many questions while counseling patients in the intervention group compared to the control group (p < 0.001). After controlling for patients\' demographics and pharmacists\' questions, there was a statistical difference between the two patient groups in their odds of expressing at least one concern utterance.
CONCLUSIONS: This pilot study suggests that collecting PRO from patients with chronic illnesses and providing results to pharmacists and patients can help patients express their health and medication concerns. RxTalk™ would be useful for pharmacists who wish to improve the recognition and management of medication-related problems.

BACKGROUND: Digital diabetes prevention programs (dDPPs) are effective \"digital prescriptions\" but have high attrition rates and program noncompletion. To address this, we developed a personalized automatic messaging system (PAMS) that leverages SMS text messaging and data integration into clinical workflows to increase dDPP engagement via enhanced patient-provider communication. Preliminary data showed positive results. However, further investigation is needed to determine how to optimize the tailoring of support technology such as PAMS based on a user\'s preferences to boost their dDPP engagement.
OBJECTIVE: This study evaluates leveraging machine learning (ML) to develop digital engagement phenotypes of dDPP users and assess ML\'s accuracy in predicting engagement with dDPP activities. This research will be used in a PAMS optimization process to improve PAMS personalization by incorporating engagement prediction and digital phenotyping. This study aims (1) to prove the feasibility of using dDPP user-collected data to build an ML model that predicts engagement and contributes to identifying digital engagement phenotypes, (2) to describe methods for developing ML models with dDPP data sets and present preliminary results, and (3) to present preliminary data on user profiling based on ML model outputs.
METHODS: Using the gradient-boosted forest model, we predicted engagement in 4 dDPP individual activities (physical activity, lessons, social activity, and weigh-ins) and general activity (engagement in any activity) based on previous short- and long-term activity in the app. The area under the receiver operating characteristic curve, the area under the precision-recall curve, and the Brier score metrics determined the performance of the model. Shapley values reflected the feature importance of the models and determined what variables informed user profiling through latent profile analysis.
RESULTS: We developed 2 models using weekly and daily DPP data sets (328,821 and 704,242 records, respectively), which yielded predictive accuracies above 90%. Although both models were highly accurate, the daily model better fitted our research plan because it predicted daily changes in individual activities, which was crucial for creating the \"digital phenotypes.\" To better understand the variables contributing to the model predictor, we calculated the Shapley values for both models to identify the features with the highest contribution to model fit; engagement with any activity in the dDPP in the last 7 days had the most predictive power. We profiled users with latent profile analysis after 2 weeks of engagement (Bayesian information criterion=-3222.46) with the dDPP and identified 6 profiles of users, including those with high engagement, minimal engagement, and attrition.
CONCLUSIONS: Preliminary results demonstrate that applying ML methods with predicting power is an acceptable mechanism to tailor and optimize messaging interventions to support patient engagement and adherence to digital prescriptions. The results enable future optimization of our existing messaging platform and expansion of this methodology to other clinical domains.
BACKGROUND: ClinicalTrials.gov NCT04773834; https://www.clinicaltrials.gov/ct2/show/NCT04773834.
UNASSIGNED: RR2-10.2196/26750.

BACKGROUND: Mindfulness-based treatments gained popularity for migraine treatment. In this manuscript we report the results of a single-arm open pilot study that evaluated the impact of a multimodal web-based intervention combining home-based medication withdrawal, patients\' education, and online mindfulness-based interventions. We aimed to address whether our program had the ability to show a change in the observed parameters and the study should therefore be intended as an early phase trial.
METHODS: Consecutive patients with chronic migraine associated with medication overuse headache were enrolled, followed-up for 12 months, in a program that included home-based medication withdrawal, education on the correct use of drugs and lifestyle issues, prescription of tailored pharmacological prophylaxis, and attendance to six online mindfulness-based sessions. We tested the effect of the program on improving headache frequency, medication intake, quality of life (QoL), headache impact, depression, self-efficacy, and pain catastrophizing.
RESULTS: A total of 37 patients completed the study (10 dropped out). We observed a large improvement in headache frequency, medication intake, headache impact, and QoL, a moderate improvement in pain catastrophizing and a mild improvement in depression symptoms; 70% to 76% of patients achieved 50% or more reduction in headache frequency from baseline to each follow-up (p < .01).
CONCLUSIONS: The results of our multimodal program showed significant improvements in headache frequency, medication intake, and patient-reported outcomes. Future studies are needed to better identify patients who might benefit most from Digital Health Interventions and to demonstrate at least an equivalence in outcome with in-person programs carried out in hospital settings.

BACKGROUND: Optimal rehabilitation programs for orthopedic joint replacement patients ensure faster return to function, earlier discharge from hospital, and improved patient satisfaction. Digital health interventions show promise as a supporting tool for re-enablement.
OBJECTIVE: The main goal of this mixed methods study was to examine the usability of the AIMS platform from the perspectives of both patients and clinicians. The aim of this study was to evaluate a re-enablement platform that we have developed that uses a holistic systems approach to address the de-enablement that occurs in hospitalized inpatients, with the older adult population most at risk. The Active and Independent Management System (AIMS) platform is anticipated to deliver improved patient participation in recovery and self-management through education and the ability to track rehabilitation progression in hospital and after patient discharge.
METHODS: Two well-known instruments were used to measure usability: the System Usability Scale (SUS) with 10 items and, for finer granularity, the User Experience Questionnaire (UEQ) with 26 items. In all, 26 physiotherapists and health care professionals evaluated the AIMS clinical portal; and 44 patients in hospital for total knee replacement, total hip replacement, or dynamic hip screw implant evaluated the AIMS app.
RESULTS: For the AIMS clinical portal, the mean SUS score obtained was 82.88 (SD 13.07, median 86.25), which would be considered good/excellent according to a validated adjective rating scale. For the UEQ, the means of the normalized scores (range -3 to +3) were as follows: attractiveness=2.683 (SD 0.100), perspicuity=2.775 (SD 0.150), efficiency=2.775 (SD 0.130), dependability=2.300 (SD 0.080), stimulation=1.950 (SD 0.120), and novelty=1.625 (SD 0.090). All dimensions were thus classed as excellent against the benchmarks, confirming the results from the SUS questionnaire. For the AIMS app, the mean SUS score obtained was 74.41 (SD 10.26), with a median of 77.50, which would be considered good according to the aforementioned adjective rating scale. For the UEQ, the means of the normalized scores were as follows: attractiveness=2.733 (SD 0.070), perspicuity=2.900 (SD 0.060), efficiency=2.800 (SD 0.090), dependability=2.425 (SD 0.060), stimulation=2.200 (SD 0.010), and novelty=1.450 (0.260). All dimensions were thus classed as excellent against the benchmarks (with the exception of novelty, which was classed as good), providing slightly better results than the SUS questionnaire.
CONCLUSIONS: The study has shown that both the AIMS clinical portal and the AIMS app have good to excellent usability scores, and the platform provides a solid foundation for the next phase of research, which will involve evaluating the effectiveness of the platform in improving patient outcomes after total knee replacement, total hip replacement, or dynamic hip screw.