JMIR Research Protocols

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.

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

Structured AbstractO_ST_ABSImportanceC_ST_ABSRemote sampling technologies are invaluable for protecting both participants and researchers when studying highly infectious diseases. When leveraged for longitudinal studies, remote sampling with transcriptomic readouts is a powerful tool for studying the host immune response. Additionally, remote study flexibility circumvents common barriers to research participation including length of commute, transportation, and scheduling, thereby expanding access to clinical research. ObjectiveIn this work, we investigate the effectiveness of a remote study model for reaching women from underrepresented, underserved, and underreported (U3) populations. We sought to recruit individuals who qualify as underrepresented in clinical research, who are located in rural areas, or who come from disadvantaged backgrounds per the NIH definition. DesignIn this longitudinal study, U3 women positive for COVID-19 were enrolled and followed over the course of 6 months. In the first month of the infection, participants (n = 40) self-collected a set of 5 nasal swabs, 5 homeRNA-stabilized blood samples, and 2 additional unstabilized blood samples at first and last sampling. Sampling time points were spaced 5 days apart, so that the total of the 5 time points was completed within 25 days. homeRNA is a platform for remote self-collection of blood samples with subsequent RNA stabilization. A subset of participants likely to develop post-acute sequelae of COVID-19 (PASC) and their age-matched controls were selected to self-collect an additional set of 5 nasal swabs and 5 homeRNA-stabilized blood samples during month 3 of study participation, with the same sampling frequency. All participants were resurveyed at months 4, 5, and 6 about their symptoms. Participants also completed surveys at each sampling and a more comprehensive survey about study experience after each set of 5 time points. SettingThis was a fully remote study with all sampling supplies and instructions shipped to the participants. Participants self-collected blood and nasal swabs at home and shipped these back to our lab for further processing. Surveys were administered electronically using REDCap. ParticipantsFor this study, we enrolled women who were 18 or older, met the NIH criteria for U3, and who had tested positive for SARS-CoV-2 within a week of enrollment. Further, we excluded protected populations including individuals who were pregnant and/or incarcerated. Of the 334 individuals who completed the screening process, 65 were invited into the study based on the eligibility criteria and balancing age, race/ethnicity, and state of residence to closely correspond to the demographics of the United States. Of the 65 invited individuals, 40 were fully enrolled in the study and 39 completed all study components. Main Outcomes and MeasuresPrior to the study, we proposed that the increased flexibility of a remote study design would allow for participation of populations underrepresented in clinical research. The primary measurements planned for this study consisted of usability data and general experience in a longitudinal study. These data were collected by self report using electronically administered surveys. The Consolidated Framework for Implementation Research (CFIR), a well-established implementation science framework, was used to guide the development of questions about usability and study experience. Results40 women were recruited from 19 states, with diverse racial backgrounds (62% White, 15% Black or African American, 10% Asian, 5% American Indian or Alaska Native, 5% Other, 3% More than one race), a mostly even age distribution (26% ages 20 - 29, 15% ages 30 - 39, 31% ages 40 - 49, 28% ages 50+), and most of whom (80%) are categorized as having a disadvantaged background per the NIH. Survey responses show high satisfaction with the study, where all participants who completed the study (100%, n = 39/39) indicating that they would be willing to participate in a similar study again, with most (n = 32/39) indicating a willingness to participate for up to 4 years with around 15 samples collected per year. We note that 4 years was the longest time period that participants were able to select in their surveys, suggesting that participants may be willing to participate for even longer periods. Most (>90%) either agreed or strongly agreed that all components of the kit were easy to use. Conclusions and RelevanceThe high retention (98%, n = 39/40) and satisfaction of participants in this study indicates the utility of a remote study design for longitudinal research. We also find that study topic, flexibility of study, and positive interactions with the study team are important factors for participant recruitment and retention. This work suggests that the increased flexibility of a fully remote design enables engagement of individuals who may otherwise be excluded from clinical research.

Despite the global prevalence of postpartum depression (PPD), current referral uptake rates are far from satisfactory. While some qualitative studies have investigated factors affecting PPD referrals, a gap in quantitative analysis remains. Addressing this, our study utilized a discrete choice experiment (DCE) to understand the procedural elements influencing PPD referral uptake among diagnosed women. The DCE was conducted via home visits by healthcare providers and a comprehensive mobile app questionnaire. We constructed seven distinct referral attributes to explore participants' preferences, analyzed using mixed logit models and latent class analysis. This analysis identified key determinants and revealed the heterogeneities in referral preferences. A total of 698 individuals completed the DCE questionnaire. All assessed attributes, except for Accompaniment (going to clinic with a family member), were important determinants of preference. Participants generally preferred referrals to psychiatric clinics, face-to-face consultations, lower costs, and shorter waiting times. Significantly, participants' personal and socio-demographic characteristics also played a critical role in their referral preferences. Latent class analysis categorized participants into four distinct groups based on their preferences, with treatment cost and waiting times being the most decisive factors. In conclusion, the preference for PPD referrals is predominantly driven by convenience and access to specialist care. To enhance referral uptake, developing flexible and personalized referral programs that cater to these preferences is crucial.

This systematic review and meta-analysis aimed to evaluate the effectiveness of relaxation interventions on anxiety, depression, stress, and quality of life in women with infertility. A comprehensive search of PubMed, OVID MEDLINE, CINAHL(R), Google Scholar, and Korean databases was conducted for articles published through March 2025. Keywords included combinations of terms related to infertility, ART, and nursing or psychotherapeutic interventions. The search identified 759 records, of which 13 met the eligibility criteria. Methodological quality was assessed using the Cochrane Risk of Bias tool, and data analysis was performed using R software (version 4.3.2). The meta-analysis included 10 randomized controlled trials (RCTs) and three non-randomized controlled trials (NRCTs), comprising 1,215 women undergoing ART. Intervention groups received relaxation programs, while comparison groups received usual care or no intervention. Relaxation interventions were associated with significant reductions in anxiety (Hedges g = -0.69) and depression (Hedges g = -0.38), and significant improvements in quality of life (Hedges g = 0.25). No statistically significant effect was observed for stress (Hedges g = -0.01; 95% CI: -0.49 to 0.47). Heterogeneity and risk of publication bias were determined to be low. Overall, relaxation programs demonstrated beneficial effects on anxiety, depression, and quality of life, but not on stress levels. Relaxation interventions appear to support the psychological well-being of women undergoing ART, with particular benefit for women with a history of repeated treatment failure. Individualized, woman-centered approaches may be more responsive to the needs of this population than universal or group-based models of care.

BackgroundNursing interns are at high risk of psychological distress due to academic and clinical stressors. While poor sleep quality is linked to anxiety and depression, the buffering role of social support remains underexplored in this population. AimsTo explore the role of social support in regulating the relationship between sleep and mental health among nursing interns. MethodsA total of 396 nursing interns completed self-administered questionnaires including the Pittsburgh Sleep Quality Index (PSQI), Social Support Rate Scale (SSRS), Generalized Anxiety Disorder-7 (GAD-7), and Patient Health Questionnaire-9 (PHQ-9). Hierarchical regression and simple slope analyses were used to test moderation effects. ResultsPoor sleep quality was significantly associated with higher anxiety ({beta}=0.449, P<0.001) and depression ({beta}=0.535, P<0.001). Social support significantly moderated these relationships. Under low social support, the effects of sleep quality on anxiety ({beta} = 0.602) and depression ({beta} = 0.779) were stronger than under high support (anxiety: {beta} = 0.396; depression: {beta} = 0.515). ConclusionsSocial support buffers the adverse psychological effects of poor sleep among nursing interns. Interventions should integrate sleep hygiene education with strategies to enhance social support.

BackgroundPerinatal mood and anxiety disorders are the most common complications of pregnancy. Given the limited mental health resources, there is a need for novel treatment approaches. Though smartphone applications can increase access to evidence-based care, recent research highlights notable limitations, including varying quality and unclear effectiveness. Blended hybrid care models, which integrate synchronous telehealth services with asynchronous modalities (such as mobile apps), have emerged as an alternative. This pilot study evaluates one such model, the Digital Clinic, to determine its potential to bridge this critical treatment gap and compare outcomes to that of non-peripartum patients in the clinic. MethodsPregnant and postpartum women referred for anxiety and depression received 8 weeks of synchronous, virtual, evidence-based CBT from a trained clinician. This treatment was complemented by the asynchronous use of the mindLAMP app, providing digital phenotyping, psychoeducation, and CBT skills, with the support of a Digital Navigator. The efficacy of the intervention was evaluated by comparing GAD-7 and PHQ-9 scores from intake to the end of treatment. ResultsThis secondary analysis included 13 peripartum women from a larger sample of 224 clinic patients. At intake, they reported a mean PHQ-9 score of 9.4 (SD=3.9) and a mean GAD-7 score of 11.69 (SD=6.0). After 8 weeks, participants reported statistically significant decreases of 4.14 points on the GAD-7 (p<.01) and 3.92 points on the PHQ-9 (p<.01). Effect sizes for these reductions were 0.74 (95% CI: 0.20, 1.28) for GAD-7 and 1.10 (95% CI: 0.29, 1.90) for PHQ-9. ConclusionA novel blended hybrid care model, the Digital Clinic, was successful in reducing depression and anxiety among pregnant and postpartum women. This novel approach to maternal mental health shows promise for delivering accessible, effective, evidence-based care to peripartum patients in real-world settings. Future work should further validate its effectiveness with larger, more diverse patient populations with moderate to severe disease.

Background: The European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines on nutrition for cancer patients provides evidence based dietary recommendations that is routinely deployed by dieticians in oncology settings. Although these can be culturally adapted, they do not adequately address inter individual variability in treatment related gastrointestinal symptoms and appetite, issues that increase malnutrition risk in cancer patients. Ayurveda, on the other hand, lacks nutrient based guidelines but offers a well grounded dietary framework to assess digestive function and personalise diets. This study investigated the feasibility of combining the two approaches in a clinical setting. Methods: Consenting adult cancer patients diagnosed with any type and stage of cancer were recruited. At baseline, digestive strength, dietary intake, quality and frequency and Patient Generated Subjective Global Assessment (PGSGA) score were recorded. Based on this, personalised meal plans (MPs) that combine nutrient guidelines from ESPEN and traditional food concepts to support digestive strength were provided to participants. Follow ups ranged from 4 weeks to 6 months, at which digestive strength and PGSGA was noted. To evaluate against a benchmark, meal plans were theoretically constructed using Ayurveda concepts (traditional MP) or ESPEN guidelines (Standard MP) alone. Results: Data is presented for 33 participants, of which 52% had weak digestive strength. Baseline intake averaged 879 kcal/day, well below the recommended 1400 to 1600 kcal/ day level. Traditional MPs improved energy intake but were protein insufficient, aspects that were addressed in the standard MPs. Diet quantity (1417 kcal/day), quality and frequency improved on the integrated MP, with 3 patients achieving optimal digestive strength. Personalised counselling reduced malnutrition risk, as reported by PGSGA score. Conclusion: Customising dietary advice by overlaying nutrient guidelines with Ayurveda dietary concepts is feasible. The evaluation of digestive strength holds promise for personalising nutrition therapy. Trial Registration: CTRI/2023/07/055657

BackgroundOrganization, time management, and planning (OTMP) difficulties are associated with academic underachievement. OTMP skills training programs are effective in reducing OTMP deficits and improving academic performance. A randomized controlled trial of Homework, Organization, and Planning Skills (HOPS) for students ages 11-14 (1) found it to be effective with medium to large effects. In that study, HOPS was provided by counselors employed by the research team. This study is a replication examining HOPS under more authentic conditions when providers are employed by schools serving enrolled students. The primary aim is to evaluate HOPS offered by school providers in relation to treatment-as-usual/waitlist (TAU/WL). To respond to limited school resources post-COVID-19, HOPS is also provided by research team members, creating the opportunity to replicate the findings from the prior trial (1) and explore differential effectiveness when HOPS is implemented by school vs. research providers. MethodsStudents in about 30 schools serving students ages 11-14 will be enrolled. Schools are randomly assigned to HOPS vs. TAU/WL on a 2:1 ratio. Students assigned to HOPS schools are randomly assigned to a school vs. research provider on a 1:1 basis. Providers receive two hours of training and additional assistance on request. Child outcomes related to OTMP skills, homework, and academic performance are assessed at post-treatment, 6-month (from baseline) follow-up, and 12-month follow-up. HOPS sessions are video recorded for fidelity coding. Potential effect modifiers include student ADHD, oppositional defiant, and internalizing symptoms, and family socioeconomic level. Analyses will use mixed effects modeling. The goal of the study is to enroll 135 participants, yielding a minimal detectable effect size of 0.50, within the expected range based on prior research. DiscussionThe study is unique in examining intervention implementation and effectiveness when intervention is provided under authentic practice conditions. Trial RegistrationThis study was registered with clinicaltrials.gov (NCT04465708).

BackgroundEmergency obstetrics and newborn care training improves the knowledge and skills of healthcare professionals. However, there is limited evidence on training programs that had been informed by training needs analysis. The aim of the study was to determine training needs of registered midwives to inform a training program. MethodsA descriptive cross-sectional study design was used to collect data from N=202 midwives who worked at two comprehensive emergency obstetrics and neonatal care hospitals. Simple random sampling was used to select respondents. Ethics approval was obtained before conducting the study. Data were collected from November 2023 to January 2024 using an adapted self-administered Hennessy Hicks Training Needs Questionnaire. SPSS version 29 was used to analyze the data. Descriptive statistics, means and standard deviations were calculated. The differences between task importance and task performance were determined for each of the measured items. A paired sample t-test was used to establish the significance of the differences between each of the five category pairs with p=<.05. ResultsThe mean age of the 202 respondents was 38.06{+/-}6.9 years. The midwives predominantly fell into the age group 40-44 years (n=53, 22.2%), and they had an average of 5-9 years of work experience (n=75, 37.1%). Training needs were perceived for all the measured items. The research/ audit category emerged as the highest (M=2.23{+/-}1.05) training need, followed by clinical (1.94{+/-}0.55), administrative (1.70{+/-}1.03), communication (1.57{+/-}0.79) and supervisory tasks (1.14{+/-}0.76). Differences between each of the five category pairs were statistically significant with p=<.05. The highest specific training need was newborn resuscitation (n= 61, 30.2%). ConclusionThe study highlights the need for training on research and clinical tasks. RecommendationTailor training according to the identified needs for the effective management of emergency obstetrics and newborn complications.

Background The Precision rEsearCh pArticipatioN (PECAN) study aims to explore factors that influence perceptions of precision health research participation, focusing on diverse communities in South Carolina. The objective is to identify both positive and negative factors affecting participation, enabling the development of strategies to enhance understanding and reduce barriers, particularly within a population facing significant health disparities. Methods To ensure the effectiveness of the survey instrument for the PECAN study, researchers conducted a cognitive study through guided group discussions with community members. These discussions were designed to pinpoint survey questions that participants found difficult to understand, hard to answer, or unclear. The insights gained from this cognitive evaluation were used to refine and improve the survey, ensuring it is clear, uniform, and effective for gathering meaningful data. Results The cognitive interview study identified several survey items that participants found challenging or ambiguous, particularly due to complex wording, culturally irrelevant content, and questions requiring extensive recall. Participants emphasized the need for clearer language, reassurance about anonymity, and the use of biological terms, as well as greater cultural representation. Based on this feedback, researchers revised the survey to simplify language, provide contextual disclaimers about specimen collection, depersonalize genetic testing questions, and restructure redundant items. Conclusions The cognitive interview study was instrumental in enhancing the PECAN survey's clarity and effectiveness. By addressing participants' feedback, the researchers were able to create a more accessible survey instrument. These improvements are expected to facilitate better data collection, ultimately contributing to a deeper understanding of factors influencing precision health research participation among diverse populations. This methodology highlights the importance of participant feedback in developing research tools that are both inclusive and effective.

BackgroundAdvance care planning in older persons with palliative care needs is often not (timely) initiated. Certified nursing assistants are closely involved in the (daily) care for older persons and have important insights regarding their clients care preferences and quality of life. However, their role in advance care planning is currently overlooked. AimTo examine the perspectives of nursing assistants on their role in advance care planning for older persons. DesignA qualitative descriptive study design using semi-structured interviews. Setting/participantsFifteen nursing assistants working in community care and nursing homes in the Netherlands were interviewed between March and December 2023. A combined inductive and deductive thematic analysis was performed using the Capability, Opportunity, Motivation Behavioral model. ResultsMost nursing assistants were not structurally involved in advance care planning and were in need of additional knowledge and skills (capability). The team culture affected nursing assistants opportunities and motivation to participate in advance care planning both positively and negatively. The opportunity was further shaped by nursing assistants relationship with clients and relatives and time management, while motivation also depended on personal circumstances. ConclusionThis study found several barriers and facilitators affecting nursing assistants role in advance care planning for older persons. Structurally involving nursing assistants in advance care planning, supporting their work environment, and empowering them can foster equal collaboration with other healthcare professionals. This might contribute to the timely initiation of advance care planning and palliative care for older persons. Key statementsi) What is already known about the topic?O_LIAdvance care planning enables patients, relatives, and involved healthcare professionals to define and discuss goals and preferences for current and future medical treatment and care. C_LIO_LICertified nursing assistants are often closely involved in the (daily) care for older persons and their relatives, providing important insights into their preferences and quality of life. C_LIO_LINursing assistants are currently not structurally involved in the interprofessional collaboration regarding advance care planning. C_LI ii) What this paper addsO_LIVariation was observed in nursing assistants roles in advance care planning across care teams and settings, with most indicating a need for additional knowledge and skills (capability). C_LIO_LIThe team culture affected nursing assistants opportunities and motivation to participate in advance care planning both positively and negatively. C_LIO_LIThe opportunity was further shaped by nursing assistants relationship with clients and relatives and time management, while motivation was also depended on personal circumstances. C_LI iii) Implications for practiceO_LIStructural involvement of certified nursing assistants in advance care planning can contribute to timely initiation of advance care planning and palliative care for older persons. C_LIO_LIA supportive work environment that enables nursing assistants to develop their skills and grow professionally can facilitate an advance care planning process involving the expertise of all healthcare professionals. C_LIO_LIThe empowerment of nursing assistants could help them to become a more equal partner in advance care planning in collaboration with other involved professionals. C_LI

Background: Young women in Ghana (18-35 years) remain disproportionately affected by HIV due to intersecting structural and social challenges, including stigma, gendered power dynamics, and limited access to women-centered prevention services. Although HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP) are effective biomedical prevention strategies, uptake among young Ghanaian women remains low. Barriers include limited awareness, persistent stigma, and a lack of culturally relevant, youth-responsive prevention approaches. The WISE WOMAN study aims to address these gaps by developing and piloting a women-centered HIV prevention intervention co-created with young women in Ghana. Methods: This protocol describes a pilot implementation study of a women-centered HIV prevention intervention that will be delivered via WhatsApp. The intervention is informed by community-based participatory research and human-centered design approaches to enhance cultural relevance and responsiveness to young womens lived experiences. The study will enroll 50 young women aged 18-35 years who will participate in a four-week WhatsApp-based intervention designed to increase HIV prevention knowledge, reduce stigma, and support engagement with HIVST and PrEP. Implementation outcomes, including feasibility, acceptability, and appropriateness, will be assessed using mixed methods. Quantitative data will be collected through baseline and post-intervention surveys, including the PIERS-22 engagement scale, and will be analyzed using descriptive statistics and paired comparisons. Qualitative data from group interactions and post-intervention interviews will be analyzed using thematic analysis. The study has received ethical approval from the University at Buffalo Institutional Review Board (STUDY00009328) and the Ensign Global College Ethics Committee (IRB/EL/AF-02/2025) and is registered at ClinicalTrials.gov (NCT07003789). Discussion: This protocol outlines the design and methods for a digitally delivered, women-centered HIV prevention intervention grounded in participatory approaches. The planned pilot study will generate critical implementation evidence on the feasibility, acceptability, and appropriateness of a WhatsApp-based, co-designed intervention, informing future adaptation, scale-up, and integration of culturally grounded HIV prevention strategies for young women in Ghana and similar settings.

Background: With an aging population and increasing comorbidities, supporting people to remain at home for as long as possible is essential. A major challenge in home care is ensuring coordinated, interprofessional collaboration among all actors involved: patients and their close ones, health and social care professionals, and the broader health and social network. To address this challenge, a new organizational model promoting reinforced interprofessional collaboration, the "Reseau Interprofessionnel Ambulatoire de Proximite" (Local Interprofessional Outpatient Network; RIAP) has recently been developed in the canton of Geneva. The aim of this paper is to present the protocol for a research project evaluating both the effectiveness and implementation of this model. Methods: This is a type-2 hybrid effectiveness implementation study guided by the RE-AIM framework, aiming to evaluate the RIAP organizational model and its implementation, context, and outcomes. This multi-method study will examine the RIAP model under real-world conditions. Routinely collected data on patient outcomes and institutional processes will be used to compare the RIAP model with usual care. Questionnaires will assess patients' perceptions of continuity of care, professionals' perceptions of interprofessional collaboration, and stakeholders' views on the acceptability of the model. Open-ended questions will be included to explore experiences and insights in greater depth, complemented by qualitative data on barriers and facilitators to implementation. Financial indicators will also be analyzed to contextualize the model within the institutional setting. Results: The EFFI-RIAP project began in October 2025 and has a planned duration of 22 months. The project will primarily rely on the reuse of institutional routine data, complemented by questionnaires and interviews scheduled for September 2026. At the time of submission, study preparation and institutional data processing are ongoing. Discussion: This research will provide insights into the clinical, organizational, and implementation-related effects of the RIAP model compared with usual care. The natural deployment of new RIAP teams will enable investigation of the organizational model under real-world conditions. The combined evaluation of the effectiveness and implementation of RIAP will assess the model's added value, inform refinement, and identify potential barriers and facilitators relevant to implementation in other teams.

Background: Lifestyle interventions incorporating medically-tailored meal delivery may support rapid behavior change among pregnant individuals with gestational diabetes (GDM). Purpose: To examine the feasibility and acceptability of a multicomponent lifestyle intervention for pregnant individuals with GDM. Primary outcomes included recruitment, retention, intervention receipt, and acceptability. Methods: We conducted a pilot randomized feasibility trial among pregnant individuals with GDM recruited from maternal fetal medicine clinics in the Hartford, Connecticut area. Participants were randomized to usual GDM care or the Meals4Moms intervention plus usual care. The intervention included medically-tailored meal delivery, personalized physical activity support, and multimodal education with digital tools. Participants completed a survey and three 24-hour dietary recalls at baseline and post-intervention. Meals4Moms participants also completed a semi-structured interview at follow-up. Intervention receipt was tracked by study staff. Results: Of 30 individuals approached, we screened 80% (n=24), of whom 75% (n=18/24) were eligible; we randomized 8 participants. Seventy-five percent (n=6/8) completed at least one component of the follow-up assessment (100%, n=4/4 Meals4Moms, 50%, n=2/4 Usual Care). One participant spent [&ge;]80% of her total food budget (n=1/4, 25%), and no participants completed [&ge;]80% of prescribed exercise sessions (range: 0-50%). All (n=4) Meals4Moms participants reported they would be very likely to participate in the program if they had GDM again, and 100% (n=4) would be very likely to recommend the program to a friend with GDM. Conclusions: While the Meals4Moms intervention was highly acceptable to participants, procedural refinements are needed prior to conducting a full-scale efficacy trial.

Abstract The ISBAR framework is used to standardize clinical handovers and enhance patient safety. Observational tools based on ISBAR have been developed to assess the completeness of information transfer. However, these instruments have primarily been developed in non-Chinese contexts, and validated Chinese-language observational tools suitable for clinical practice remain limited. In this study, a cross-cultural adaptation and psychometric validation of the ISBAR Structured Handover Observation Tool was conducted, examining its reliability and discriminant validity in Chinese clinical settings. The study was conducted in two phases: cross-cultural adaptation and psychometric evaluation in real-world clinical settings. Content validity was assessed using the Content Validity Index (CVI), and inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC) based on a two-way mixed-effects model with absolute agreement. Discriminant validity was examined using the Mann-Whitney U test to compare scores across nurses with varying levels of clinical experience. A total of 233 handover cases involving patient transfers from the intensive care unit (ICU) to general wards were collected, involving 84 nurses. The scale demonstrated good content validity, with item-level content validity indices (CVI) ranging from 0.88 to 1.00 and a scale-level CVI/Ave of 0.98. The inter-rater reliability, assessed using fifty randomly selected cases, was high, with an intraclass correlation coefficient (ICC) of 0.885 for single-rater assessments and 0.939 for average-rater assessments. Discriminant validity analysis showed that nurses with more clinical experience had significantly higher total scores than those with less experience (Z = -4.772, p < 0.001). The Chinese version of the ISBAR Structured Handover Observation Tool demonstrates good content validity, high inter-rater reliability, and acceptable discriminant validity. This tool provides a standardized and practical method for assessing the completeness of information transfer and is expected to support quality improvement in patient handover from the ICU to general wards in Chinese clinical settings.

IntroductionColorectal cancer (CRC) remains a leading cause of cancer-related morbidity and mortality worldwide, despite advances in conventional oncological therapies. In recent years, various studies have made advances in integrative oncology, such as investigating the use of Chinese Herbal Medicine (CHM) as a complementary therapy alongside conventional oncological therapies to alleviate treatment-related adverse effects, improve quality of life, and potentially enhance therapeutic outcomes. Despite this, clinical practice in this area remains highly heterogeneous, with limited standardized guidelines on key areas of concern such as (1) optimal intervention, (2) recommended stage and duration of intervention, (3) safety considerations, and (4) possible herb-drug interactions. Hence, this study aims to establish expert consensus on the usage of CHM as a complementary therapy in the management of CRC, to support safe, consistent, and evidence-informed clinical practice. Methods and AnalysisWe will employ a modified Delphi technique to achieve consensus amongst a panel of international experts in various fields related to integrative oncology. Prior to the study, a list of questionnaire items was developed based on a systematic review of existing clinical practice guidelines on CRC. An international panel will be invited based on established international profile in integrative oncology research and clinical practice, and by peer referral. Two rounds of Delphi will be conducted using anonymous online questionnaires. Consensus will be considered reached if at least 50% of the panel strongly agree/disagree that an item should be included or excluded while strong consensus will be set at 76%. Items which achieve strong consensus after Round 1 will be removed, before being sent out for Round 2 with a summary of Round 1 responses for a final consensus. Ethics and DisseminationEthics approval has been obtained from the Institutional Review Board of Nanyang Technological University (IRB-2025-1222). Our findings will be disseminated through peer-reviewed publications and conference presentations. Strengths and limitations of this studyO_LIThis study will develop an expert consensus which aims to guide future integration of Chinese Herbal Medicine (CHM) as a complementary therapy into colorectal cancer (CRC) management. C_LIO_LIKey concerns in areas such as determining the (1) optimal intervention, (2) recommended stage and duration of intervention, (3) safety considerations, and (4) possible herb-drug interactions, thereby laying the groundwork for potential future incorporation of CHM into CRC treatment protocols alongside conventional oncology approaches has been identified, thus limiting implementation in clinical practice. C_LIO_LIDesigning a study e-guide, followed by the consensus rounds study online will facilitate participants responses and the dissemination of information from previous rounds. C_LI

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

BackgroundText messages are a low-cost digital health solution that can provide information directly to mothers. We aimed to evaluate a text message program, called Essential Coaching for Every Mother Tanzania (ECEM-TZ), designed to improve maternal access to essential newborn care education during the immediate 6-week postnatal period. MethodsA randomized controlled trial was conducted in Dar es Salaam, Tanzania. ECEM-TZ consists of standardized text messages from birth to 6 weeks postpartum that provided evidence-based information on newborn care and recognizing danger signs. The primary outcome was newborn care knowledge. Secondary outcomes included parenting self-efficacy, breastfeeding self-efficacy, postpartum depression and anxiety symptoms, attendance at the six-week postnatal check-up, and newborn morbidity and mortality. Data were analyzed using ANCOVAs and logistical regression. ResultsBetween June 13 and July 22, 2024, 143 mothers were randomized, 71 to the control group (standard care) and 72 to the intervention group (standard care plus ECEM-TZ), of which 139 completed both the baseline and follow-up at 6-8 weeks postpartum. Compared to the control group, mothers who received ECEM-TZ had significantly higher newborn care knowledge scores (MD=2.92, p<0.001) and fewer postpartum depression symptoms (MD=-1.55, p<0.001). Mothers who received ECEM-TZ were also three times more likely to attend a postnatal visit than those in the control group (OR=3.15, 95%CI [1.29, 7.72]). ConclusionText messaging, as a low-cost, accessible digital health solution, is an important asset to enhance education of mothers in low- and middle-income countries during the immediate 6-week postpartum period. Trial registrationClinicalTrials.gov (NCT05362305), submitted 22-April-2022.

BackgroundHwa-byung (HB) is a Korean culture-bound syndrome characterised by prolonged suppression of anger and somatic complaints. No evidence-based digital therapeutic (DTx) has been developed for HB. We evaluated the feasibility, user experience (UX), and preliminary clinical effect of an acceptance and commitment therapy (ACT)-based DTx application, Hwa-free, for HB. MethodsAdults aged 19-80 years diagnosed with HB were enrolled in a four-week app-based intervention with assessment at baseline (Week 0), Week 2, Week 4, and Week 8 follow-up. The primary outcome was UX assessed via a 22-item survey at Week 4. Secondary outcomes included HB-related symptom and personality scales, depression, anxiety, anger expression, psychological flexibility, health-related quality of life, and heart rate variability. ResultsOf 45 screened, 30 were enrolled and 28 constituted the modified intention-to-treat population. Mean app use was 19.9 {+/-} 7.9 days (71.2% adherence over 28 days). Adverse events were infrequent and unrelated to the intervention. Positive response rates exceeded 80% for video content (items 2-4: 82.8-89.7%), HB self-assessment (86.2%), meditation therapy (86.2%), and in-app guidance (85.7%). Pre-post improvements from baseline to Week 4 were observed in 11 of 18 clinical scales, including HB Symptom Scale ({Delta} = -9.8, Cohens d = -0.92), Beck Depression Inventory-II ({Delta} = -13.3, d = -1.11), and state anger ({Delta} = -7.8, d = -0.96). The HB screening-positive rate declined from 100% at baseline to 55.6% at Week 8. ConclusionsHwa-free demonstrated adequate feasibility, acceptable UX, and preliminary evidence of clinically meaningful improvement in HB-related symptoms. Future randomised controlled trial is warranted. Trial registrationCRIS, KCT0011105