Assessing a Couples-Based, Digital HIV Serostatus-Neutral Intervention (Para Ti, Para Mí, Para Nosotros) for Adult Cisgender Sexual Minority Male Couples in Lima, Peru: Protocol for a 6-Month Pilot Randomized Controlled Trial.

BACKGROUND: HIV disproportionately affects sexual minority men (SMM; eg, gay, bisexual, and other men who have sex with men) in Lima, Peru; epidemiological data estimate that 32% to 39% of new HIV infections occur among adult cisgender SMM within primary partnerships (ie, male couples). Most HIV prevention-care research in Lima, Peru, has focused on SMM as individuals and not couples. To help address this critical gap in prevention care, we developed Para Ti, Para Mí, Para Nosotros (P3): a couples-based, digital HIV serostatus-neutral intervention (DHI) for adult cisgender SMM couples in Lima, Peru. The P3 DHI is designed to facilitate couples with skill-building, communication, decision-making, and working together to form and adhere to a detailed prevention care plan that aligns with their explicit sexual agreement. The P3 DHI is theoretically informed, self-guided, directed, sequential, and fully automated. OBJECTIVE: This pilot randomized controlled trial (RCT) aims to examine the preliminary effects of P3 on couples' formation and adherence to a detailed prevention care plan containing evidence-based strategies that also aligns with their explicit sexual agreement over time. In addition, the feasibility of enrollment and retention and couples' acceptability of P3 will be assessed. METHODS: The research implements a prospective, 6-month pilot RCT with a 3-month delayed control condition. After baseline, 60 enrolled SMM couples will be randomized to 1 of 2 conditions. Couples randomized to the unmatched, delayed control condition will receive access to the P3 DHI to use during the last 3 months of the trial after the 3-month assessment. Couples randomized to the immediate intervention condition will immediately receive access to the P3 DHI for 6 months. Study assessments will occur at baseline and months 3 and 6. Descriptive, comparative, qualitative, and longitudinal analyses using generalized linear mixed-effect, multilevel, and actor-partner interdependence models will be conducted to address the specific aims. RESULTS: The 6-month pilot RCT is ongoing. Recruitment, enrollment, and data collection began in January 2023 and ended in April 2024. A total of 74 adult cisgender SMM couples met all inclusion criteria, provided consent, and were enrolled in the pilot RCT. Retention was 92% (68/74) at month 6. Data are currently being analyzed to address the 3 specific aims regarding feasibility, acceptability, and preliminary efficacy. CONCLUSIONS: Findings from this research will reveal whether couples deemed the P3 DHI to be acceptable. Findings will also highlight the preliminary efficacy of the P3 DHI on couples managing their vulnerability to HIV and other sexually transmitted infections (STIs) over time via alignment of their prevention-care plan and sexual agreement. Trial findings will help shape the future direction of the P3 DHI while addressing the existing gap in prevention and care services for couples in the local context. TRIAL REGISTRATION: ClinicalTrials.gov NCT05873855; https://clinicaltrials.gov/study/NCT05873855. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63106.

Digital music and movement intervention to improve health and wellbeing in older adults in care homes: a pilot mixed methods study.

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. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov, number NCT05601102 on 01/11/2022.

Developing a Youth-Led Digital Hypertension Education Intervention for Adults With Hypertension: Qualitative Study on Refinement and Acceptability.

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.

Clients' and providers' perspectives in informing a digital health intervention to improve linkage to care after Index HIV self-testing in Hai and Moshi Districts, Tanzania.

BACKGROUND: Digital health interventions have the potential to improve linkage to care after HIV self-testing (HIVST). This study aimed to understand clients' and providers' perceptions of benefits, and barriers of a digital health intervention designed to improve linkage to care after HIV self-testing in Tanzania. METHODS: This exploratory qualitative research study was conducted in Hai and Moshi, districts in Kilimanjaro region, Tanzania. Four health facilities were selected based on their involvement in an HIVST pilot program implemented by Elizabeth Glassier Pediatric AIDS Foundation (EGPAF) Tanzania through the USAID funded program. The study included female index clients and their partners, and healthcare providers at the healthcare facilities. We used a semi-structured interview guide with open-ended questions for data collection. Data collection was conducted from 16th January 2023 to 3rd February 2023. Thematic analysis of the qualitative data was conducted, guided by the Health Belief Model (HBM), and results were developed in collaboration with the community partners. RESULTS: A total of 42 participants were included in the study, comprising 9 male clients, 17 female index clients, and 16 health care workers (HCWs) (4 male and 12 female) who were involved in delivering HIVST services. The study's findings revealed mixed feelings about the use of a digital health intervention. Majority of participants perceived digital health as a valuable intervention for enhancing linkage to care, improved health outcomes, improved communication with healthcare workers, and increased privacy. Therefore, they supported scale-up of a digital health intervention. Participants also expressed that the potential benefits of a digital health intervention include the convenience of accessing healthcare services from the comfort of their homes or any location. However, a few participants expressed concerns about potential risks associated with sending health-related text messages. They feared that recipients might not be in a safe space, leading to stigma and avoidance of engagement. A few female participants expressed concerns about confidentiality breaches, particularly regarding shared phones with family or friends. Fear of being judged or misunderstood by others could deter them from reading or acting upon these messages. Most participants recommended tailored strategies that prioritize confidentiality and trust. Recognizing these psychological aspects is vital for customizing digital health interventions to effectively address participants' concerns. CONCLUSIONS: Digital health interventions may improve the linkage of HIV self-testers to care. Recommendations include personalized and culturally relevant communication and technical accessibility to make interventions effective and inclusive. This study provides valuable insights for designing patient-centered interventions for HIV care and treatment.

Effects of a digital intervention on physical activity in adults: A randomized controlled trial in a large-scale sample.

Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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. Trial registration: German Clinical Trials Register DRKS00020249; https://drks.de/search/en/trial/DRKS00020249.

Improving the Well-Being of People With Advanced Cancer and Their Family Caregivers: Protocol for an Effectiveness-Implementation Trial of a Dyadic Digital Health Intervention (FOCUSau).

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. TRIAL REGISTRATION: ClinicalTrials.gov NCT06082128; https://clinicaltrials.gov/study/NCT06082128. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/55252.

A mixed-methods approach to assessing implementers' readiness to adopt digital health interventions (RADHI).

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. TRIAL REGISTRATION: NCT03896776, clinicaltrials.gov, 1 April 2019.

Approaches to Evaluating Digital Health Technologies: Scoping Review.

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.

Patient Perspectives on a Digital Assistant for Medication Reconciliation: An Interview Study Comparing Socioeconomic Groups.

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.

Engagement With Conversational Agent-Enabled Interventions in Cardiometabolic Disease Management: Protocol for a Systematic Review.

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. TRIAL REGISTRATION: PROSPERO CRD42023431579; https://tinyurl.com/55cxkm26. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52973.

Success Factors for Usability Testing of Digital Health Solutions.

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. METHOD: 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.

Measuring Engagement in Provider-Guided Digital Health Interventions With a Conceptual and Analytical Framework Using Nurse WRITE as an Exemplar: Exploratory Study With an Iterative Approach.

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.

Exploring the impact of a digital health tool on patients' interaction with community pharmacists: A pilot randomized controlled study.

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. OBJECTIVES: 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. STUDY DESIGN: 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. CONCLUSION: 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.

The Effects of Digital Health Interventions for Pulmonary Rehabilitation in People with COPD: A Systematic Review of Randomized Controlled Trials.

Background and Objectives: Chronic Obstructive Pulmonary Disease (COPD) is the third most common cause of death globally. Pulmonary rehabilitation (PR) programmes are important to reduce COPD symptoms and improve the quality of life of people with COPD. Digital health interventions have recently been adopted in PR programmes, which allow people with COPD to participate in such programmes with low barriers. The aim of this study is to review and discuss the reported effects of digital health interventions on PR outcomes in people with COPD. Materials and Methods: To achieve the study goals, a systematic literature search was conducted using PubMed (MEDLINE), CINAHL, AMED, SPORTDiscus and the Physiotherapy Evidence Database. Randomised clinical trials (RCTs) were included if they met specified criteria. Two reviewers independently checked titles, abstracts, and performed full-text screening and data extraction. The quality assessment and risk of bias were performed in accordance with the PEDRO scale and Cochrane Risk of Bias tool 2, respectively. Results: Thirteen RCTs were included in this systematic review with 1525 participants with COPD. This systematic review showed the potential positive effect of digital health PR on the exercise capacity-measured by 6- and 12-min walking tests, pulmonary function, dyspnoea and health-related quality of life. There was no evidence for advantages of digital health PR in the improvement of anxiety, depression, and self-efficacy. Conclusions: Digital health PR is more effective than traditional PR in improving the pulmonary and physical outcomes for people with COPD, but there was no difference between the two PR programmes in improving the psychosocial outcomes. The certainty of the findings of this review is affected by the small number of included studies.

Current status of digital health interventions in the health system in Burkina Faso.

BACKGROUND: Digital health is being used as an accelerator to improve the traditional healthcare system, aiding countries in achieving their sustainable development goals. Burkina Faso aims to harmonize its digital health interventions to guide its digital health strategy for the coming years. The current assessment represents upstream work to steer the development of this strategic plan. METHODS: This was a quantitative, descriptive study conducted between September 2022 and April 2023. It involved a two-part survey: a self-administered questionnaire distributed to healthcare information managers in facilities, and direct interviews conducted with software developers. This was complemented by a documentary review of the country's strategic and standards documents on digital transformation. RESULTS: Burkina Faso possesses a relatively comprehensive collection of governance documents pertaining to digital transformation. The study identified a total of 35 digital health interventions. Analysis showed that 89% of funding originated from technical and financial partners as well as the private sector. While the use of open-source technologies for the development of the applications, software, or platforms used to implement these digital health interventions is well established (77%), there remains a deficiency in the integration of data from different platforms. Furthermore, the classification of digital health interventions revealed an uneven distribution between the different elements across domains: the health system, the classification of digital health interventions (DHI), and the subsystems of the National Health Information System (NHIS). Most digital health intervention projects are still in the pilot phase (66%), with isolated electronic patient record initiatives remaining incomplete. Within the public sector, these records typically take the form of electronic registers or isolated specialty records in a hospital. Within the private sector, tool implementation varies based on expressed needs. Challenges persist in adhering to interoperability norms and standards during tool design, with minimal utilization of the data generated by the implemented tools. CONCLUSION: This study provides an insightful overview of the digital health environment in Burkina Faso and highlights significant challenges regarding intervention strategies. The findings serve as a foundational resource for developing the digital health strategic plan. By addressing the identified shortcomings, this plan will provide a framework for guiding future digital health initiatives effectively.

Leveraging Machine Learning to Develop Digital Engagement Phenotypes of Users in a Digital Diabetes Prevention Program: Evaluation Study.

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. TRIAL REGISTRATION: ClinicalTrials.gov NCT04773834; https://www.clinicaltrials.gov/ct2/show/NCT04773834. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/26750.

Impact of digital interventions and online health communities in patient activation: Systematic review and meta-analysis.

OBJECTIVE: Study the efficacy of digital health interventions in enhancing patient activation and identify the distinct features of these interventions using the WHO classification system. METHODS: Asystematic reviewand meta-analysis were carried out according to the PRISMA guidelines. A search was conducted in Scopus, PubMed, and ProQuest. Randomized controlled trials (RCT), quasi-randomized controlled trials, and before-and-after studies enrolling patients ≥ 18 years of age with the Patient Activation Measure (PAM) score measurement and contain digital intervention with any aspects of health education or health-related behavior were included. The Downs and Black quality assessment tool was used to assess the quality of the articles. RESULTS: In the three different types of meta-analyses, implementing the intervention led to a PAM score increase (Mean Difference (M.D.)), ranging from a minimum of (MD = 0.2014, 95 % CI = 0.0871-0.3158) and a highly significant p-value 0.0006 to a maximum of (MD = 2.7882, 95 % CI = 1.5558-4.0206) and a p-value < .0001. While the M.D. score of 0.2014 may seem relatively low, it is enough to elevate the patient from one activation level to a higher one out of the four activation levels. CONCLUSION AND PRACTICE IMPLICATIONS: The results suggest the effectiveness of digital health interventions on patient activation across diverse settings and contexts, implying potential generalizability. Using WHO classification, all examined digital interventions addressed the challenges of information, utilization, and efficiency in the health system, but not equity-related challenges. The study recognized online health communities (OHCs) as a subset of digital interventions that enhance patient activation through social support.

You're not alone: imagery rescripting for adolescents who self-harm.

Introduction: Non-suicidal self-injury (NSSI), which refers to the deliberate act of causing harm to one's own body without the intent to commit suicide, occurs in 20% of youth. Interestingly, approximately 90% of individuals who engage in self-harm report intrusive mental imagery thereof shortly prior to the act of NSSI. Previous research has demonstrated that imagery rescripting (IR) is an effective technique to treat intrusive mental images and associated clinical symptoms, such as emotion dysregulation, in various psychiatric disorders. However, there is no research on IR for adolescents who self-harm. Therefore, the present study aims to investigate the efficacy and feasibility of a two-session short-intervention using IR to reduce NSSI and associated clinical symptoms in adolescents. The intervention was supported by an app-based digital health intervention (DHI). Methods: A single case series A-B design with three post-assessments (1 week, 1 month, and 3 months post-intervention) was implemented. Seven adolescents received two treatment sessions of IR, supported by a DHI between sessions. NSSI (SITBI), emotion regulation (ERQ), emotional distress (BDI-II, STAI-T), self-efficacy (WIRKALL_r), and treatment satisfaction (BIKEP) were evaluated. Results: There was an increase in adaptive emotion regulation strategies up to 3 months post-intervention. Furthermore, patients improved regarding their self-efficacy, depressiveness, anxiety, and NSSI symptomatology. The developed DHI was described as a helpful and supportive tool. Conclusion: The intervention has shown initial evidence to be feasible and beneficial for adolescents conducting NSSI. The DHI has demonstrated to be a valuable tool in the treatment of self-harming youth.

Methods, Indicators, and End-User Involvement in the Evaluation of Digital Health Interventions for the Public: Scoping Review.

BACKGROUND: Digital health interventions (DHIs) have the potential to enable public end users, such as citizens and patients, to manage and improve their health. Although the number of available DHIs is increasing, examples of successfully established DHIs in public health systems are limited. To counteract the nonuse of DHIs, they should be comprehensively evaluated while integrating end users. Unfortunately, there is a wide variability and heterogeneity according to the approaches of evaluation, which creates a methodological challenge. OBJECTIVE: This scoping review aims to provide an overview of the current established processes for evaluating DHIs, including methods, indicators, and end-user involvement. The review is not limited to a specific medical field or type of DHI but offers a holistic overview. METHODS: This scoping review was conducted following the JBI methodology for scoping reviews based on the framework by Arksey & O'Malley and complies with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Three scientific databases (PubMed, Scopus, and Science Direct) were searched in April 2023. English and German studies between 2008 and 2023 were considered when evaluating DHIs that explicitly address public end users. The process of study selection was carried out by several researchers to avoid reviewer bias. RESULTS: The search strategy identified 9618 publications, of which 160 were included. Among these included articles, 200 evaluations were derived and analyzed. The results showed that there is neither a consensus on the methods to evaluate DHIs nor a commonly agreed definition or usage of the evaluated indicators, which results in a broad variety of evaluation practices. This aligns with observations of the existing literature. It was found that there is a lack of references to existing frameworks for the evaluation of DHIs. The majority of the included studies referred to user-centered approaches and involved end users in the evaluation process. As assistance for people developing and evaluating DHIs and as a basis for thinking about appropriate ways to evaluate DHIs, a results matrix was created where the findings were combined per DHI cluster. Additionally, general recommendations for the evaluators of DHIs were formulated. CONCLUSIONS: The findings of this scoping review offer a holistic overview of the variety and heterogeneity according to the approaches of evaluation of DHIs for public end users. Evaluators of these DHIs should be encouraged to reference established frameworks or measurements for justification. This would ease the transferability of the results among similar evaluation studies within the digital health sector, thereby enhancing the coherence and comparability of research in this area.

A Digital Health Intervention Platform (Active and Independent Management System) to Enhance the Rehabilitation Experience for Orthopedic Joint Replacement Patients: Usability Evaluation Study.

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.