Pilot and Feasibility Studies

AimTo outline the opportunities and barriers when using hairdressing salons as a novel site for enhancing cardiovascular risk factor assessment and management in women. MethodsA process evaluation nested within a cluster-randomised trial, Hairdressers for Health. The trial evaluated a nudge intervention advising women [≥]45years attending hairdressing salons to undertake a Heart Health Check with their General Practitioner. The UK Medical Research Council process evaluation framework was used to guide the design, data collection and analysis. Nineteen interviews were conducted with nine hairdressers, nine study participants and a project officer. Thematic analysis assessed recruitment, reach, acceptability, and adoption. Characteristics of the salons and participants were analysed using descriptive statistics. ResultsRecruitment of the planned 88 metropolitan and 28 regional salons for the trial was challenging, requiring resource-intensive face-to-face visits. The nudge intervention was well accepted by participants, and salons were perceived to be an appropriate setting to effectively reach women. Adoption of the study by salons was limited with only 54 of the 116 salons recruiting participants (total recruited 239, range 1-22 participants per salon). Barriers to participant recruitment included technological constraints while using a decentralised online recruitment and data collection platform, client preferences and privacy concerns. Established hairdresser-client relationships in smaller salons facilitated greater client participation and was perceived as a good mechanism for health promotion. ConclusionsCardiovascular health prevention messaging for women in salons was acceptable to hairdressers and clients. Designing the study to make better use of hairdresser-client personal relationships may have improved project implementation. Trial RegistrationACTRN12621001740886

BackgroundCommunication issues across the primary-secondary care interface are considered one of the most important challenges in improving patient safety in primary care in the UK. Teleconferencing offers a potential means of improving communication during referrals but is largely unevaluated. AimTo explore teleconferencing as an alternative to written Advice and Guidance (A&G) referrals for neurology cases, by assessing its impact on GP-specialist communication and relationships, and exploring implications for patient care. Design and SettingA qualitative case study of a primary care network (PCN) and a secondary care centre in East Anglia. Methods18 clinicians and 10 other stakeholders were interviewed. Observations of teleconferences and a focus group with five PCN staff provided additional data. Data collection and analysis were guided by the Consolidated Framework for Implementation Research and Reflexive Thematic Analysis. ResultsAdvantages of teleconferencing identified by participants included greater clinician satisfaction, mutual educational value, streamlined patient journeys and continuity of care. Teleconferences were also seen to build GP-specialist relationships and reduce unnecessary outpatient referrals. Perceived issues included time constraints, clinical governance and funding sustainability; teleconferences were not seen as appropriate for all referrals. Overall, participants welcomed the teleconference approach but stressed the need to robustly assess its cost-effectiveness and replicability in other settings. ConclusionTeleconferencing is a potentially promising alternative to written A&G referrals and was perceived by participants to help build GP-specialist relationships. However, further studies are needed to assess clinical effectiveness and costs, and to guide future development and implementation. How this fits inO_ST_ABSWhat is known?C_ST_ABSReferral interventions involving direct GP-specialist dialogue can enhance referral quality, reduce outpatient referrals and improve GP-specialist relationships, with some demonstrating improved clinical outcomes. However, they often face sustainability challenges, and their cost-effectiveness and mechanisms of impact require further assessment. What does this study add?This qualitative study identifies key mechanisms through which virtual GP-specialist dialogue may lead to downstream benefits: enabling shared decision-making and delivering consultant-level care closer to home; empowering GPs to manage complex cases; and reducing overall workload across primary and secondary care systems. The programme theory developed can be used to guide future intervention design, implementation and evaluation.

BackgroundIndividuals with severe mobility impairments (SMI) often experience significant psychological distress and chronic pain. Virtual walking (VW) presents an innovative rehabilitation approach to improve mood and alleviate pain. This study aimed to develop a home-based VW system with integrated mood and symptom tracking and to report on its feasibility and usability in a user study with individuals with SMI. MethodsA multidisciplinary, iterative frame-work guided the systems development. Following initial contextual research and design iterations, a user study was conducted with 11 participants with SMI. A repeated measures pre-post design was employed. Feasibility and usability were primarily assessed through post-study qualitative interviews, analyzed via content analysis. Changes in mood and symptoms were measured immediately before and after each session. Momentary mood was captured using an in-virtual reality (in-VR) two-dimensional (2D) affect grid, while embedded single-item state ratings were used to track anxiety, depressed mood, and pain. Daily mood changes and symptom trajectories were analyzed using logistic regression and generalized estimating equations (GEE), respectively. ResultsContextual research guided the system design towards enhancing accessibility, ergonomics, and therapeutic engagement. The final VW system featured three core modules: locomotion, multi-sensory feedback, and mood/symptom tracking. Qualitative analysis of the user study revealed high acceptance for the VW system, alongside challenges related to content variety and hardware ergonomics. Each intervention session was significantly associated with an immediate positive mood shift (odds ratio (OR) = 1.83), as measured by the affect grid. Furthermore, GEE models revealed a significant reduction in self-reported depression and anxiety symptoms over the intervention period (all P < 0.01). ConclusionsThis study confirms the feasibility and acceptability of the novel VW system for home-based use by individuals with SMI. The preliminary evidence suggests the system has high potential as a tool for improving mood and alleviating psychological distress. Future large-scale randomized controlled trials are warranted to establish its clinical efficacy. Trial registration numberNCT07073144-07/17/2025.

BackgroundHypertension is a major modifiable risk factor for cardiovascular disease, yet blood pressure (BP) control remain suboptimal, particularly in socially disadvantaged communities. Guidelines recommend initiating single-pill combination (SPC) therapy to improve adherence and BP control, but uptake in primary care is limited. ObjectivesTo evaluate the SOLO care improvement project, promoting SPC initiation among general practitioners (GPs) in Amsterdam Zuidoost, a disadvantaged, multi-ethnic community in The Netherlands with a high hypertension burden. MethodsIn a cluster quasi-randomized cluster design, adult hypertensive patients from nine general practices within one health facility were allocated to intervention (IC; n=5) or usual care (UC; n=4). Intervention practices received case-specific guidance on SPC therapy. Outcomes were SPC uptake, changes in systolic and diastolic BP (SBP and DBP), target BP achievement and cardiovascular events. Analyses used intention-to-treat adjusted regression and Cox models, with additional as-treated analysis among SPC users. ResultsAmong 438 patients (mean age 64.5{+/-}12.2 years; median follow-up of 367 days [213-467]), SPC initiation was higher in the IC than US (25.1% vs. 9.6%, p<0.001). SBP/DBP decreased by -15.7/-6.9 mmHg in the IC and -10.4/-4.6 mmHg in the UC. Target BP was more often achieved in the IC (57.3% vs. 48.1%; OR: 1.4, 95%CI:1.0-2.1). Among SPC users, SBP/DBP decreased by -22.4/-10.5 mmHg. ConclusionPromoting SPC therapy improved blood pressure control, supporting local, targeted implementation as a pragmatic strategy to enhance hypertension management. Summary box, bullet points- In the SOLO care improvement project, SPC initiation was increased and improved blood pressure control in routine primary care. - The real-world implementation and cluster-based comparison enhanced practical relevance and reduced contamination between practices. - Although conducted in a large community health center, generalizability cannot be assumed; the non-blinded, non-randomized design allows residual confounding.

Artificial intelligence (AI), particularly large language models (LLMs), is increasingly explored in healthcare, yet its real-world usability and safety in high-risk clinical pharmacy tasks remain uncertain. Vancomycin therapeutic drug monitoring (TDM), which requires precise pharmacokinetic calculations and context-sensitive interpretation within a narrow therapeutic window, provides a stringent test case for AI-assisted decision support. This proof-of-concept study developed and evaluated a hybrid clinical decision support system (TDM-AID) integrating a validated deterministic pharmacokinetic calculation engine, GPT-4o-based structured clinical interpretation, and retrieval-augmented guideline support. Thirty retrospective adult vancomycin TDM cases were assessed using a weighted six-domain rubric covering pharmacokinetic accuracy, AUC estimation, prospective prediction, timing recommendations, clinical judgment, and documentation quality. Two independent expert pharmacists evaluated system outputs against benchmark consultations. The overall median performance was 78% (IQR 12%), classified as Acceptable, and 73% (IQR 14%) when deterministic calculations were excluded. Foundational pharmacokinetic calculations achieved 100% accuracy. Clinical judgment demonstrated Good performance (83%), whereas prospective prediction was limited (58%), and timing recommendations were absent in all cases. Safety violations occurred in 17% of cases, including dose recommendations exceeding 4 g/day. Inter-rater reliability was good (ICC 0.87). These findings suggest that hybrid AI-driven decision support is technically feasible and usable as a pharmacist-augmenting draft generator; however, limitations in predictive reasoning, timing logistics, and safety enforcement necessitate deterministic safeguards and mandatory expert oversight before clinical implementation.

PurposeRobotic walkers are a new and novel technology with growing evidence of benefits for children living with mobility impairments. However, little is known about how using these devices at home impacts families. This study aims to explore parents perceptions of home-based robotic walking and the impacts on their family and their child living with a mobility impairment. Materials and MethodsQualitative interviews were conducted with seven parents who have a child who used a robotic walker in their home for at least six months. Thematic analysis was used to analyze all interviews. Themes were then mapped to the F-words for child development. ResultsUsing a robotic walker at home led to family bonding and created new ways for parents and siblings to interact with the child living with a mobility impairment. Many children enjoyed using the robotic walker. This, combined with being able to direct its use in their own environments, contributed to less parental stress than was associated with other rehabilitation interventions. However, some parents discussed an increase in parental stress due to certain logistical aspects, getting their child in and out and transporting the robotic walker. Finally, parents discussed that obtaining the device was a financial burden for them. ConclusionRobotic walking in the home environment impacts family relationships and parental stress. Understanding families experiences can inform decision-making by families and practitioners around the appropriateness of robotic walker use for a child living with a disability.

Community health workers (CHWs) in low-resource settings deliver variable-quality care. This study used OpenAIs o3 and Googles Gemini Flash 2.5 to evaluate whether large language models (LLMs) listening to CHW-patient interactions could generate accurate referral decisions. Across 150 participating Rwandan CHWs, 429 encounters were recorded (in Kinyarwanda) and then processed by LLMs. CHWs demonstrated high referral accuracy (97.9% [95% CI: 96.1%-98.9%]), and OpenAIs o3 performed similarly to CHWs while Gemini 2.5-Flash showed low accuracy (47.3% [95% CI: 42.6%-52.1%]). Assessment of LLM-generated differential diagnoses and management plan quality showed superior performance from o3 compared with Gemini, though both models missed important conditions. In conclusion, the choice of LLM appears to be a critical design decision. Moreover, the high baseline performance of Rwandan CHWs suggests that LLMs are likely to have a limited impact in the current context but could be useful in less well-established CHW programmes. Trial Registration: PACTR202504601308784.

Background Older adults' walking has so far been evaluated using standardised assessments of walking capacity within a clinical setting. By taking the evaluation out of the laboratory into the real world, this study provides first evidence of the ability of Digital Mobility Outcomes (DMOs) to detect changes over time and the Minimal Important Difference (MID) in patients after proximal femoral fracture (PFF). This will guide the implementation of DMOs in research and clinical care. Methods For this multicenter prospective cohort study, 381 community-dwelling older adults were included within one year after sustaining a PFF and assessed at two time points, separated by six months. Walking activity and gait DMOs were measured using a single wearable device worn on the lower back for up to seven days. A global impression of change question and three mobility-related outcome measures (Late-Life Function and Disability Instrument; Short Physical Performance Battery; 4m gait speed) were used as anchor variables. To assess each DMOs ability to detect changes, we calculated the standardized mean change as effect size. For estimating MIDs, both distribution-based and anchor-based methods were applied, followed by triangulation by experts if at least three anchor-based estimates were available per DMO, resulting in single-point estimates. Results All three anchor variables demonstrated substantial changes. Overall, 10 out of 24 available DMOs showed large and 7 DMOs moderate positive effects in the expected direction of the respective anchors. Seven DMOs showed no or only small effects. For 12 DMOs, at least three anchor-based estimates were available, enabling MID triangulation. MIDs for walking activity DMOs per day were: a walking duration of 10 minutes, a step count of 1,000 steps, 50 walking bouts (WB), and 15 WBs in WBs over 10 seconds. For gait DMOs, depending on the walking bout length, MIDs for walking speed were between 0.04 m/s and 0.08 m/s, and MIDs for cadence between 4 and 6 steps/minute. Almost all DMOs showed a strong ability to detect improvement in mobility, but rarely in detecting decline. Conclusions For the first time, MIDs are presented for real-world DMOs in PFF patients. These MIDs inform sample size requirements and interpretation of intervention effects for clinical trials, thereby providing guidance and reassurance for clinicians and regulatory bodies.

BackgroundReactive balance training using repeated perturbations may reduce falls, however, training methods are not easily replicated or translatable to clinical settings. This study aimed to examine the effects of a novel reactive balance training program on balance recovery from laboratory induced trips and slips and fall risk factors in older people using simple and low-cost equipment. MethodsWe conducted a randomised controlled trial involving 88 older people. An intervention group (n = 43) received the ReacStep program which involved tether-release reactive stepping and intentional slips once a week for 6 weeks. Both the intervention and control (n = 45) groups received home-based strength training for 8 weeks. Blinded staff assessed reactive balance (laboratory induced falls), physical functions at baseline (week 1) and post intervention (week 8). Weekly SMS surveys ascertained falls in daily life over 12 months. ResultsBoth groups were comparable in demographics, with a mean age of 72 years (SD = 5.6). Adherence to ReacStep sessions was high (90%). There were no significant differences between groups in laboratory-assessed reactive balance falls at post-test or daily-life falls over one year (P =.19). However, at post-test, the intervention group demonstrated significant improvements in usual gait speed, maximum step length, and choice stepping reaction time compared to controls (P <.05). ConclusionsThe ReacStep program demonstrated excellent adherence, was well tolerated, and improved gait parameters required for balance recovery following postural perturbations in older people. Nevertheless, it appears this program is not sufficient to improve reactive balance against unexpected trips and slips. Key pointsO_LIThe ReacStep program is acceptable, demonstrates excellent adherence and improves gait measures in older people, potentially reducing fall risk. C_LIO_LIThe generalisability against unexpected trips, and slips, and falls in daily life may be limited. C_LIO_LIFuture research should explore more ecological perturbations while maintaining its accessibility and acceptability. C_LI

IntroductionDespite improvements in treatment for people living with HIV (PWH), adherence remains a challenge for many. In this study we aimed to identify preferences for daily pill or long-acting injectable (LAI) antiretroviral therapy (ART) and for possible treatment package features, among PWH enrolled in Ryan White HIV/AIDS Program Part A (RWPA) Medical Case Management (MCM) programs. MethodsParticipants were recruited from six MCM programs from across the New York RWPA eligible metropolitan area (the five boroughs of New York City and Rockland, Putman, and Westchester counties). We developed a discrete choice experiment (DCE) with four attributes: (1) Type of ART Medication (daily pills or LAI), (2) Service Location and Mode, (3) Support, and (4) Rewards. We used an alternative-specific design in which the levels for the last three attributes were dependent on levels within the first (Type of ART). Latent class multinomial logit analysis (LCA) was used for preference estimation and hypothesis-free investigation of preference heterogeneity. ResultsFrom June 2022 through January 2023, 200 New York RWPA MCM clients completed the DCE. We selected a two-group LCA solution. A majority of participants had a higher preference for LAI regimens compared to daily pills (n=114 [57%] versus n=86 [43%]). Those who preferred LAI ART were younger (median age 49 versus 58.5 years, p<0.001), less likely to identify as straight/heterosexual (69% versus 82%, p=0.03), and more likely to identify as Latino/a (54% versus 30%; p<0.001). Preferences for service locations/mode, supports, and rewards were similar across LCA groups. Participants who preferred LAI ART were more likely to have heard of LAI ART before the survey (59% versus 41%, p=0.012). Overall, only 4% of participants self-reported having tried LAI ART. ConclusionsAssessing preferences among groups under-represented in clinical trials is essential to effective and equitable real-world implementation of innovative treatment options. Our study found that there were distinct groups that differed in their preferred ART regimen type and that New York RWPA MCM clients had limited familiarity with LAI ART. To inform regimen selection, we began pilot-testing educational materials and a patient-provider decision-making tool in 2023.

BackgroundDespite recommendations in clinical guidelines, clinical experience indicates that engagement with splints and orthotics varies amongst people after stroke. ObjectivesThe aim of the study was to understand the factors that influence engagement with splints and orthotics in people after stroke. MethodsPeople after stroke who had been wearing a splint or orthotic (also known as devices) for at least 2 months under the care of one Community Neurosciences Team in the UKs National Health Service were included. Semi structured interviews based on the constructs of Banduras Social Cognitive Theory (SCT) were used to gather participants views, and a framework analysis applying the constructs of SCT was completed using NVIVO software. ResultsFour key themes were identified: 1. Self-Regulation; difficulties applying the device and aesthetic acceptability. 2. Self-Efficacy; increased confidence when wearing the device and reduced motivation to wear the device. 3. Outcomes Expectation; reduced falls risk, improved gait, improved balance, maintaining range of movement, and negative effects such as discomfort, pain, itching. 4. Social Support; support needed to apply the device and the burden on family members/carers to apply the device correctly. ConclusionsThe findings of this study highlight key factors that influence engagement with orthotics and splints. These include difficulty applying the device after stroke, device aesthetics, comfort, and the importance of continued support from carers. Manufacturers should consider how people after stroke can independently don and doff devices. Education of carers and family members also appears key to support their engagement.

IntroductionAtrial fibrillation (AF), a common arrhythmia, is associated with impaired quality of life (QoL) and increased stroke risk and mortality. Clinical guidelines recommend leveraging digital technologies to support patient education and AF self-management. Conversational artificial intelligence (AI) technologies may support patient engagement with self-management by enabling human-like conversations. This study aims to evaluate the effectiveness of a conversational AI intervention (Conversational HeAlth supporT in Atrial Fibrillation Self-Management - CHAT-AF-S) in improving QoL in patients with AF. Methods and analysisCHAT-AF-S is a 3-month randomised controlled trial with 1:1 allocation and embedded process evaluation. We will randomise 480 adults (18 years of age and older) with documented AF to the CHAT-AF-S intervention or usual care. Primary outcome is the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) overall score. We will follow intention-to-treat principles and data analysts will be blinded. Intervention participants will be invited to complete a user experience survey and take part in an interview to explore the feasibility, acceptability, perceived utility, and barriers and enablers to implementing the intervention. Qualitative data will be analysed thematically. Ethics and disseminationEthics approval was obtained from the Western Sydney Local Health District Human Ethics Research Committee (2023/ETH00765). Written and informed consent will be obtained from all study participants before commencing any study procedures. Results will be disseminated via peer-reviewed publications and presentations at international conferences. Declaration of InterestsAll investigators report nil conflicts of interest. Data AvailabilityThe data that supports this project are available from the corresponding author upon reasonable request. Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12623000850673 https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386249

PurposeTo address high levels of depression and anxiety among college students, innovative, feasible, and effective treatment approaches with high potential for dissemination in university counseling centers are needed. This pilot study aimed to develop a toolkit and training intervention to support implementation of nature-based physical activity into group therapy in a university counseling center, and to evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention from the perspective of both therapists and participating clients. MethodsPhysical activity researchers and staff therapists collaborated to develop an 8-week therapy group, with each 90-minute weekly session incorporating discussions of cognitive behavioral strategies for managing anxiety and 30 minutes of moderate-intensity outdoor physical activity. Measures included staff surveys completed pre/post training, standard client assessments (Group Session Rating Scale and Counseling Center Assessment of Psychological Symptoms), and a group facilitator interview. ResultsIn Spring 2025, six students enrolled in the inaugural group. All students completed the group, demonstrated high satisfaction (M=8.78/10 across all sessions), and reductions in depression (d=0.96) and social anxiety (d=0.82). Staff confidence to discuss and recommend nature-based physical activity increased from 7.05 (pre-training) to 8.48 (follow-up). Group therapy facilitators reported high enjoyment and desire to continue offering the group. ConclusionThis study highlights an innovative intervention with promise for translation across university counseling center contexts. The toolkit and training intervention developed for this study could provide a blueprint for other university counseling centers to offer similar therapy groups and expand the integration of nature-based physical activity into mental health services. Keywords: anxiety, college students, group therapy, physical activity, nature

Introduction"Encompass" is a participatory group-based intervention originating from low- and middle-income countries, co-developed with parents and professionals to enhance the wellbeing, health literacy and empowerment of caregivers of young children with complex neurodisability. We aimed to assess feasibility and acceptability of a) intervention delivery in two socially deprived United Kingdom (UK) urban areas and b) evaluation methods including data collection on programme outcomes and costs. MethodsWe conducted a mixed-methods pilot and feasibility study with caregivers of children under five years with complex neurodisability. Feasibility and acceptability of intervention delivery were assessed based on recruitment rates, group attendance, fidelity checklists and qualitative interviews with caregivers and facilitators. Feasibility and acceptability of evaluation methods were explored through follow-up rates, questionnaire completeness, and caregiver feedback on outcome measures. Data relating to implementation at organisational and system levels were explored through interviews with facilitators and key partners. Results were compared to predefined traffic light criteria (green, amber, red) to determine whether a larger scale evaluation was warranted. ResultsEight caregivers participated in the programme. Fidelity of delivery and follow-up questionnaire completion met green criteria, while recruitment and attendance met amber criteria, indicating that minor adaptations are required before scaling up. Qualitative findings demonstrated high acceptability of the programme among caregivers and facilitators, particularly valuing the co-facilitation model, participatory approach, and peer support. Flexible delivery, including online participation and communication support, enhanced accessibility for families with diverse needs. Capturing programme delivery costs was feasible and provided preliminary estimates to inform future economic evaluation. ConclusionsOur findings provide proof of principle that "Encompass" can feasibly and acceptably be delivered and evaluated with caregivers of children with complex neurodisability in an ethnically diverse UK community health setting. The findings support progression to a larger-scale evaluation, with refinements to recruitment strategies and delivery logistics. Patient or Public ContributionCaregivers with lived experience were central to developing the "Encompass" programme and this study. Four local mothers of children with complex neurodisability contributed to planning, recruitment, and sense-checking the findings.

BackgroundIn the United States, emergency clinicians are often the first to care for injured patients in the hospital setting. To better understand end-user needs, we evaluated emergency clinician priorities and preferences in accessing, interpreting, and applying trauma clinical guidance. MethodsEmergency clinicians were recruited via email for semi-structured video conference interviews. Rapid directed qualitative analysis of interview notes and audio recordings yielded initial insights about guidance barriers and facilitators. A subsequent quantitative survey was developed and distributed via email to members of relevant professional associations. Survey results were analyzed using descriptive and inferential statistics. ResultsTwelve emergency clinicians participated in interviews. 154 eligible participants responded to the survey. Clinicians expressed support for trauma clinical guidance overall but often find resources lacking. Barriers to guidance usage include lack of awareness, difficulty locating guidance, and cumbersome design. Clinical guidance should be objective, concise, updated, and easy-to-use at bedside. The strongest determinant of guidance usability was being quickly understood in a time-pressured situation. Clinicians prefer to access guidance through mobile applications or multi-modal channels. Rural clinicians reported additional difficulties in staffing and having resources needed to follow guidance. ConclusionWhen developing trauma clinical guidance, the trauma community should continue to consider the variety of end users and clinical settings, including emergency clinicians. Developing mobile device-friendly, quickly understandable guidance should be a priority for authors of trauma clinical guidance.

PurposeCaregivers of children with complex neurodisability frequently experience high caregiving demands, social isolation, unmet support needs, and reduced wellbeing. This paper explores caregivers perceptions of the impact of "Encompass", a ten-modular, community-based group support programme for caregivers of children under five with complex neurodisability, co-facilitated by an expert parent. Materials and methodsThis study formed part of a pilot and feasibility study conducted in two socially disadvantaged, ethnically diverse urban areas in the United Kingdom. Outcome measures were collected pre-intervention, post-intervention and at three-month follow-up to explore caregiver wellbeing, empowerment, activation, and quality of life. Semi-structured qualitative interviews were conducted within three months of programme completion. Interview data were analysed using deductive coding informed by the "Encompass" programme theory alongside inductive analysis to explore mechanisms and unanticipated benefits. Results and conclusionsSeven participating caregivers described improved wellbeing, increased confidence in caring for their child, navigating services, advocating for their family and engaging in the community. Peer support, shared learning and expert parent facilitation were key identified mechanisms of impact. Data from outcome measures showed patterns of improvement post-intervention, with less consistent eYects at follow-up. Findings confirmed the key change mechanisms, informing future iterations and other caregiver group programmes. Trial RegistrationClinicalTrials.gov Identifier: NCT06310681

Structured AbstractO_ST_ABSObjectiveC_ST_ABSThis mixed-methods study investigated the lived-experience perspectives of receiving a novel, brief digital mental health intervention after psychological trauma. The online gamified imagery-competing task intervention (ICTI) involves one researcher-guided session followed by self-use. Tested in two randomised controlled trials (GAINS-01; GAINS-02), ICTI led to fewer intrusive memories at week-4, with the reduction sustained over 24 weeks, alongside reductions in post-traumatic stress. Here, we contrasted user experiences of ICTI with an Active Control (AC; music-listening task), and explored longer-term impact in qualitative interviews to contextualise GAINS-02 findings. Methods and AnalysisThe GAINS-02 trial randomised healthcare staff experiencing intrusive memories after work-related trauma to ICTI (N=40), AC (N=39), or treatment-as-usual (TAU; N=20). Expectancy was assessed before the researcher-guided session (Day 0), acceptability at week-4, and usage tracked for 24-weeks. Semi-structured interviews (N=27) were conducted in ICTI and AC arms only (15 at week-4; 12 during 12-24-weeks). Interviews were analysed using reflexive thematic analysis. ResultsPrior to use, many trial participants did not think the intervention would work, favouring AC over ICTI. However, after completing the tasks, participants found ICTI more acceptable and relevant to intrusive memories than AC. After the one guided session, median ICTI usage the next four weeks was 4.00 times with little additional use (once more) over the next 20 weeks because of lack of need. Potential implementation facilitators included ease of use, and advantages over existing interventions due to not needing to talk about the trauma, brevity, and lesser resource commitment. Perceived barriers included a lack of staff and manager education about the nature and consequences of intrusive memories, with a need for workplace buy-in and demonstration of organisational benefits. ConclusionHealthcare staff experiencing workplace-related trauma found ICTI to be acceptable and effective for reducing intrusive memories with low effort and emotional burden, even among participants who initially expressed scepticism. Participants highlighted implementation considerations including offering ICTI both within and outside the workplace, and providing a self-guided version of ICTI with optional support. Future work should assess cost-effectiveness, impacts on presenteeism and retention, and real-world implementation including the feasibility and effectiveness of a self-guided ICTI. Summary BoxO_ST_ABSWhat is already known on this topicC_ST_ABSIn a previous randomised controlled trial (GAINS-01) with Intensive Care Unit (ICU) staff exposed to work-related trauma, a brief online gamified imagery-competing task intervention (ICTI) reduced intrusive memories compared to usual care at four-weeks. What this study addsThe GAINS-02 randomised controlled trial replicated GAINS-01 and extended results by comparing ICTI to an active control (AC; music listening) task, enrolling hospital staff from outside ICU, and a follow-up period of 24-weeks. Qualitative interviews found that, despite initial scepticism from healthcare staff prior to using the intervention, ICTI was more acceptable than an AC due to specific effects on swiftly reducing intrusive memories and requiring minimal support or usage after an initial researcher-guided session. After one guided session, ICTI was used 4 more times in the first four weeks, with little additional usage (once) thereafter because of lack of need (i.e., no longer experiencing intrusive memories). How this study might affect research, practice or policyICTI is an efficacious scalable intervention to relieve staff of intrusive memories with effects sustained for at least 6-months. It was found to be more acceptable to participants than alternatives, requiring less time commitment than standard psychological treatments.

BackgroundCardiovascular disease remains the leading cause of global morbidity and mortality. The original My Heart Counts smartphone application demonstrated the feasibility of large-scale, fully digital recruitment and trial conduct, but was limited by platform exclusivity and the need for human experts to create text-based behavioral interventions. MethodsThe next-generation My Heart Counts smartphone application is a prospective, observational cohort study with an embedded randomized crossover trial, evaluating personalized text-based coaching prompts, available in both English and Spanish. All study and trial operations will be conducted via the My Heart Counts smartphone application, re-designed using the open-source Stanford Spezi framework to support iOS, with a planned Android release in 2027. The target enrollment is N=15,000 adults across the United States and United Kingdom. The study establishes a comprehensive digital biobank by synthesizing passive mobile health data (steps, flights climbed, heart rate, sleep, workouts), raw sensor data (e.g., accelerometry), longitudinal clinical surveys, active tasks (6-minute walk test and 12-minute Cooper run test), electrocardiograms (ECG), and electronic health record (EHR) data integrated via HL7 FHIR protocols. The embedded trial evaluates the effect of text-based coaching prompts generated by a large language model (LLM) grounded in the Transtheoretical Model of Change on daily physical activity, as compared to generic prompts. Planned AnalysisThe primary endpoint of the randomized crossover trial is change in daily step count between LLM-driven and generic text-based intervention arms, analyzed using mixed-effects models. Secondary endpoints include change in mean active minutes and calorie burn over each intervention week. Other analyses include the changes in submaximal (6-minute walk test) and maximal (Cooper 12-minute run test) cardiorespiratory fitness, changes to sensor-derived biomarkers (e.g., sleep quality, resting heart rate, and heart rate variability), and association of sensor-derived biomarkers with EHR-confirmed clinical outcomes. ConclusionsBy utilizing autonomous, LLM-driven coaching, modular software design, and cross-platform accessibility, our smartphone application-based study will provide a scalable model for inclusive and decentralized preventive care of patients with cardiovascular disease. Trial StatusRecruitment commenced in March 2026 and is ongoing.

ObjectivesArtificial intelligence (AI)-enabled digital stethoscopes combine phonocardiography and electrocardiography to support detection of cardiac rhythm and structural abnormalities. This study evaluated the feasibility and exploratory diagnostic performance of AI-guided cardiac auscultation during routine general practice consultations and home visits. MethodsIn this prospective feasibility study, 50 consecutive patients aged [&ge;]65 years underwent AI-assisted auscultation using the Eko CORE 500 during routine care. Recordings were attempted at four standard cardiac positions. Feasibility outcomes included technical failure, workflow disruption, and proportion of analyzable recordings (defined as successful AI output based on combined ECG and phonocardiography signals). Exploratory diagnostic performance was assessed against previously established diagnoses of atrial fibrillation (AF), heart failure (HF), or valvular heart disease (VHD) documented in the electronic medical record. ResultsAI-guided cardiac auscultation was completed in all patients without device malfunction or meaningful workflow disruption (median acquisition time 1-2 minutes). At least one analyzable recording was obtained in 47/50 patients (94%), and complete four-position analyses in 42/50 (84%). Signal limitations were mainly attributable to obesity, chest hair, or excess breast tissue. Among 47 analyzable patients, 11 had known AF, HF, or VHD. Sensitivity for detecting these conditions was 81.8% and specificity 91.7%. One new case of clinically relevant mitral regurgitation was identified. ConclusionsAI-enabled digital auscultation was feasible in routine general practice, with high rates of analyzable recordings and minimal workflow impact. Larger studies with contemporaneous reference standards are warranted to determine clinical utility.

IntroductionDespite progress in HIV prevention, adolescents and young adults in sub-Saharan Africa remain disproportionately affected by HIV. In Ghana, youth aged 15-24 years face persistent barriers to accessing HIV prevention services, including stigma, limited awareness of prevention options, and insufficient availability of youth-friendly services. Emerging and existing prevention approaches, including HIV self-testing, oral, and long-acting injectable pre-exposure prophylaxis offer important opportunities to reduce HIV infections among youth. However, successful uptake depends on delivery strategies that reflect young peoples priorities and lived experiences. The Youth-Friendly Innovation Tools for HIV Prevention in Ghana (Y-FIT Ghana) study uses a youth-led, participatory approach to co-create strategies that support youth-friendly HIV self-testing and PrEP uptake. MethodsY-FIT Ghana is a mixed-methods, participatory study grounded in Youth Participatory Action Research and Human-Centered Design, and guided by Social Cognitive Theory. The study will follow a three-phase innovation pipeline: (1) a national open call to solicit youth-generated ideas related to HIV prevention; (2) an HIV Innovation Sprint to refine and develop selected concepts; and (3) a one-week bootcamp focused on capacity building and implementation readiness. Adolescents and young adults aged 15-24 years will be recruited nationwide and engaged as co-designers throughout the study. Data collection will include participatory activities, qualitative assessments, and implementation-focused measures to examine feasibility, acceptability, perceived appropriateness, and youth engagement related to HIV self-testing, oral PrEP, and LAI-PrEP. Qualitative data will be analyzed using thematic analysis, and quantitative data will be summarized using descriptive statistics, with integration across methods to inform refinement of youth-friendly HIV prevention strategies. Expected ResultsThe study is expected to demonstrate that participatory innovation can produce feasible, youth-driven HIV prevention solutions. Participants are anticipated to gain knowledge, leadership skills, and self-efficacy while developing innovative prototypes suited for youth-friendly delivery. Ethics and disseminationEthical approval has been obtained from the University at Buffalo (IRB ID: STUDY00009385) and the Ghana Health Service (ID NO: GHS-ERC-030/05/25) Institutional Review Boards. Findings will be disseminated through peer-reviewed publications, youth- and community-facing outputs, stakeholder engagement activities, and policy-relevant briefs to inform youth-centered HIV prevention efforts in Ghana and similar settings.