Protocol of the pilot study to test and evaluate the iCARE tool: a machine learning-based e-platform tool to make health prognoses and support decision-making for the care of older persons with complex chronic conditions

Introduction
The provision of optimal care for older adults with complex chronic conditions (CCCs) poses significant challenges due to the interplay of multiple medical, pharmacological, functional and psychosocial factors. To address these challenges, the I-CARE4OLD project, funded by the EU-Horizon 2020 programme, developed an advanced clinical decision support tool—the iCARE tool—leveraging large longitudinal data from millions of home care and nursing home recipients across eight countries. The tool uses machine learning techniques applied to data from interRAI assessments, enriched with registry data, to predict health trajectories and evaluate pharmacological and non-pharmacological interventions. This study aims to pilot the iCARE tool and assess its feasibility, usability and impact on clinical decision-making among healthcare professionals.

Methods and analysis
A minimum of 20 participants from each of the seven countries (Italy, Belgium, the Netherlands, Poland, Finland, Czechia and the USA) participated in the study. Participants were general practitioners, geriatricians and other medical specialists, nurses, physiotherapists and other healthcare providers involved in the care of older adults with CCC. The study design involved pre-surveys and post-surveys, tool testing with hypothetical patient cases and evaluations of predictions and treatment recommendations. Two pilot modalities—decision loop and non-decision loop—were implemented to assess the effect of the iCARE tool on clinical decisions. Descriptive statistics and bivariate and multivariate analysis will be conducted. All notes and text field data will be translated into English, and a thematic analysis will be performed. The pilot testing started in September 2024, and data collection ended in January 2025. At the time this protocol was submitted for publication, data collection was complete but data analysis had not yet begun.

Ethics and dissemination
Ethical approvals were granted in each participating country before the start of the pilot. All participants gave informed consent to participate in the study. The results of the study will be published in peer-reviewed journals and disseminated during national and international scientific and professional conferences and meetings. Stakeholders will also be informed via the project website and social media, and through targeted methods such as webinars, factsheets and (feedback) workshops. The I-CARE4OLD consortium will strive to publish as much as possible open access, including analytical scripts. Databases will not become publicly available, but the data sets used and/or analysed as part of the project can be made available on reasonable request and with the permission of the I-CARE4OLD consortium.

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Aprile 2025

Involvement of common risk factors in the associations between lifetime unemployment exposure, major health outcomes and mortality: a retrospective and prospective study in a large population-based French cohort

Objectives
Uncertainty exists as to what extent common risk factors are involved in the associations of unemployment with major health outcomes and mortality.

Design
A retrospective and prospective observational study.

Setting
A large population-based French cohort (CONSTANCES).

Participants
99 430 adults at baseline who have been exposed to unemployment during their lifetime and 54 679 of them who were followed for 7 years after baseline.

Primary outcome measures
Testing the mediating roles of several risk factors at baseline in the associations of lifetime unemployment exposure with cardiovascular disease, cancer and mortality rates during a 7-year follow-up. Direct and indirect effects were calculated for each risk factor and all together using logistic regression models adjusted for major confounders including sex, age, parental histories of cardiovascular disease and cancer, social position and working conditions.

Results
Estimates (95% CIs) of the direct and indirect effects for smoking are 0.0083 (0.0044 to 0.0122), p

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Aprile 2025

Digital health intervention to optimise heart failure management after hospital discharge in Brazil (OPT-HF): a randomised clinical trial protocol

Introduction
Guideline-directed medical therapy (GDMT) for heart failure (HF) reduces adverse events, but is underused. Global barriers to GDMT optimisation include low frequency of visits, clinician inertia and poor patient knowledge, which may be mitigated by digital health interventions (DHI). In Brazil, low digital literacy and reduced access to technology may compromise these potential DHI’s beneficial effects. Our objective is to develop and test the effectiveness of a DHI to optimise GDMT in patients recently hospitalised for HF in the Brazilian public health system (Sistema Único de Saúde (SUS)).

Methods and analysis
This is a randomised, controlled, multicentre, parallel-group, clinical trial in which 154 patients being discharged from an HF-related hospitalisation will be randomised. Inclusion criteria are ≥18 years of age, reduced ejection fraction HF (EF

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Aprile 2025

Australian immigration detention health study protocol: a prospective, mixed-methods cohort study examining the physical and mental health of refugees and asylum seekers

Introduction
Globally, studies have consistently demonstrated the harmful mental and physical health impacts of immigration detention, with high levels of distress documented among detained asylum seekers and refugees (ASR). However, the consequences of immigration detention over time on the psychological and physical health of ASR are unclear and poorly quantified.

Methods and analysis
This prospective, mixed-methods cohort study will recurrently assess and describe the health profiles of adult ASR with an experience of Australian Government-sponsored immigration detention greater than 28 days. ASR ≥18 years old released from immigration detention will be assessed at 0, 3, 6 and 12 months and annually thereafter for up to 10 years, contingent on resourcing. Five self-report scales and a structured psychiatric interview will assess the primary outcome of depression, anxiety, post-traumatic stress, pain intensity and severity, somatic symptoms, functional impairment, physical health conditions associated with detention and engagement in available treatment of this cohort. Additionally, pre-existing health records will be accessed to identify current and previous health status and assess changes in these health indices. Quantitative findings will be triangulated with a qualitative phenomenological thematic analysis of interviews to determine additional psychosocial factors associated with the outcomes.

Ethics and dissemination
The study protocol was approved by the Monash Health Human Research Ethics Committee (HREC/73614/MonH-2021-251322). Results will be reported at conferences, in peer-reviewed publications and to all relevant stakeholder groups.

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Aprile 2025

Uptake of the recently introduced vaccines among children aged 12-23 months in Ethiopia: a multilevel analysis of the 2019 Ethiopia Mini Demographic and Health Survey

Objective
Though vaccination coverage in Ethiopia has shown steady progress over the years, there are districts with below targeted vaccination coverage. This study assessed the magnitude and determinants of recently introduced vaccines uptake among children aged 12–23 months in Ethiopia.

Design
National cross-sectional study.

Setting
Ethiopia.

Participants
Mothers with children aged between 12 and 23 months.

Outcome measures
The outcome variable was the uptake of recently introduced vaccines (rotavirus vaccine (RV) and pneumococcal conjugate vaccine (PCV)) among children aged 12–23.

Results
Our analysis revealed that 45.7%, 53.4% and 43.5% of the children completed vaccination with PCV, RV and both PCV and RV, respectively. Being in the age group of 20–34 (adjusted OR (AOR)=2.03, 95% CI: 1.37 to 3.02) and 35–49 (AOR=2.44, 95% CI: 1.52 to 3.91), having at least four antenatal care contacts (AOR=2.73, 95% CI: 2.06 to 3.62), having postnatal care (AOR=1.84, 95% CI: 1.42 to 2.37), delivery in the health facility (AOR=1.45, 95% CI: 1.17 to 1.79) and having exposure to media (AOR=1.24, 95% CI: 1.09 to 1.56) and any of the wealth quintile categories higher than poorest category were positively associated with the uptake of newly introduced vaccines. Rural residency was found to be negatively associated with the uptake of newly introduced vaccines.

Conclusion
The overall full uptakes of newly introduced vaccines among children aged 12–23 months were significantly lower. Hence, this study emphasises the need to strengthen maternal and child healthcare services, particularly to the younger age mother and those with lower socioeconomic status.

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Aprile 2025

Factors influencing mobile health utilisation among patients with diabetes in Sichuan, China: a cross-sectional study based on Andersens behavioural model

Background
The development of mobile health (mHealth) in China has tremendous potential, especially for diabetes, which is one of the major chronic diseases affecting hundreds of millions of people. However, research on the current use of mHealth by patients with diabetes and the factors influencing their decision-making is insufficient. Most existing studies have approached the subject from a technological perspective and often overlooked the identity of patients as users of mHealth services. Based on the Andersen behavioural model, this study aimed to investigate the factors affecting patients’ adoption of mHealth, with a special emphasis on individual patient characteristics, and provided recommendations for the promotion of mHealth and the management of diabetes.

Method
This was a cross-sectional study. A convenience sample survey was conducted in one tertiary hospital and two community health service centres, and an anonymous self-administered questionnaire survey was conducted among patients with diabetes. Based on Andersen’s behavioural model, the questionnaire divided the influencing factors into predisposing factors, enabling factors and need factors. Multivariate logistic regression analysis was used to explore the factors influencing the utilisation of mHealth.

Results
A total of 533 questionnaires were valid. In this study, 36.8% of patients with diabetes used mHealth services. Among the predisposing factors, having better education and mHealth knowledge were found to be facilitators of mHealth utilisation, and employment status was a factor associated with mHealth utilisation. Among the enabling factors, patients with internet access and living in urban areas were more likely to have access to mHealth, and higher health literacy positively influenced mHealth utilisation. Among the need factors, self-assessed health status was linked to mHealth utilisation, and diabetes duration had a negative impact on mobile health utilisation.

Conclusions
The rate of mobile health utilisation remained low. In the future, improvements can be made in multiple aspects, such as policy, promotion, infrastructure and health education, to advance the development of mobile health and the management and control of diabetes.

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Aprile 2025

Association between health anxiety and self-triage decisions: evidence from a cross-sectional study with Australian emergency department non-urgent patients

Objective
The aim of this exploratory study was to investigate the association between health anxiety and self-triage decisions among emergency department non-urgent patients.

Design
Cross-sectional single-centre study

Setting
Emergency department in the Princess Alexandra Hospital in Brisbane, Australia

Participants
Between 13 December 2022 and 30 August 2023, an exhaustive recruitment strategy was deployed to recruit 400 patients. Eligible participants were patients aged 18 years or above who belonged to the Australasian Triage Scale category four or five (non-urgent), were physically and mentally capable of participating in the study and presented to the emergency department between 6:00 a.m. and 23:00 p.m. during the study period.

Main outcome measures
The primary outcome was accurately self-triaged decisions, while the secondary outcome was inaccurately self-triaged decisions, including both overtriaged and undertriaged decisions. Self-triage decisions were assessed using six hypothetical medical scenarios.

Results
Regression results revealed that health anxiety was not associated with accurately self-triaged decisions. However, compared with non-urgent patients exhibiting no health anxiety, those in the third and fourth quartiles (the upper two quartiles) of the Whiteley Index-6 were expected to make 0·29 (95% CI 0·09 to 0·50) and 0·25 (95% CI 0·07 to 0·44) more overtriaged decisions (mean=0·42; SD=0·71), respectively. In contrast, negative associations between health anxiety and undertriaged decisions were observed. Subgroup analyses by age showed statistically significant associations between health anxiety and inaccurately self-triaged decisions among the older adult patient group (aged 35–79 years). Moreover, analyses stratified by sex revealed that female and male patients in the fourth quartile of the Whiteley Index-6 were expected to make 0·26 (95% CI 0·02 to 0·49) and 0·27 (95% CI 0·05 to 0·48) more overtriaged decisions, respectively, compared with those with no health anxiety.

Conclusions
Our results suggest no significant association between health anxiety and accurately self-triaged decisions. In contrast, health anxiety was associated with inaccurately self-triaged decisions. This implies that patients with health anxiety overestimate the need for healthcare and therefore could substantially impact the misuse of health services, particularly emergency departments.

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Aprile 2025

Interplay of health-related quality of life and comorbidities in people with type 2 diabetes mellitus treated in primary care settings in Austria: a countrywide cross-sectional study

Objectives
This study assessed the health-related quality of life (HRQoL) and its relationship with clinical factors and comorbidities in people with type 2 diabetes mellitus (T2DM) treated in primary care settings.

Design
Cross-sectional study design: This study assessed the HRQoL using a 36-item Short Form Survey (SF-36) tool in eight domains. The HRQoL scores ranged from 0% to 100% for each domain, with higher scores indicating better HRQoL. Linear regression was used to assess the association of HRQoL domain scores with clinical covariates and comorbidities.

Setting
A countrywide study was conducted on individuals with established T2DM (N=635) attending primary healthcare services for various conditions across nine federal states of Austria from 2021 to 2023.

Participants
A total of 635 individuals, aged above 50 years and diagnosed with T2DM, were recruited by the attending physician to evaluate their HRQoL in relation to T2DM and its associated comorbidities.

Results
The mean SF-36 scores for physical functioning (69±28), role-physical (62±42), mental health (72±20), role-emotional (73±41), social functioning (79±25), bodily pain (67±28) and vitality (55±22) were satisfactory, except for general health (41±10). Age and body mass were inversely associated with physical, mental and social HRQoL (p

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Aprile 2025

Protocol of the Tailored Evidence-based Enhancements in Mental Health-Gamified and Individualized Follow-Up Treatment for Suicide (TEEM-GIFTS): a Multiphase Optimization Strategy (MOST) study implementing a gamified mHealth intervention to reduce postdischarge suicide risk in patients with mental disorders in Shenzhen

Introduction
Postdischarge suicide risk among psychiatric patients is a great concern. Gamified interventions have demonstrated promise in reducing the risk. This study aims to reduce postdischarge suicide risk through a mHealth intervention that engages and supports patients through gamified features. Built on our previous research, this study will develop, optimise and evaluate a gamified intervention under the Multi-phase Optimization Strategy (MOST) framework in implementation science.

Methods and analysis
This study will be conducted at the Shenzhen Kangning Hospital. Following the MOST framework, we will develop the gamified mHealth app (Tailored Evidence-based Enhancements in Mental Health (TEEM)) with four intervention components in the selection phase. In the optimisation phase, a factorial design randomised controlled trial (RCT) will be conducted to identify the optimised configuration. A total of 320 patients with mental disorders will be recruited and randomised into 16 groups to receive TEEM with different combinations of intervention components, with follow-ups scheduled at 1 week, 1 month, 2 months and 3 months after discharge. In the confirmation phase, we will assess the optimised TEEM through a standard RCT, comparing it to usual care. An additional 320 patients with mental disorders will be recruited for this phase, and the follow-up schedule is the same as in the optimisation phase. Psychiatric patients and family members, clinical and community mental health service providers will be recruited as the community team to help develop and evaluate the TEEM. Quantitative data will be analysed using the intention-to-treat approach and generalised estimating equations, and qualitative data will be coded and categorised to identify key themes.

Ethics/dissemination
The Ethics Committee Review Board of Shenzhen Kangning Hospital has approved this study. All participants will provide written informed consent prior to enrolment. The findings will be disseminated through peer-reviewed scientific journals and conference presentations, and a report will be submitted to the National Natural Science Foundation of China and the mental health authorities in the Shenzhen Municipal Health Commission.

Trial registration number
ClinicalTrials.gov, ID: NCT06358339

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Aprile 2025

COVID-19 vaccine uptake and associated factors among health professionals: a facility-based, cross-sectional study in the Amhara region, Ethiopia

Objectives
To determine uptake of the COVID-19 vaccine and identify the associated factors among health professionals in major cities of the Amhara region in Ethiopia.

Design
Institution-based, cross-sectional study.

Setting
The study was conducted from July to September 2022 across 40 health centres and 13 hospitals, representing 10 major cities within the Amhara region.

Participants
1251 participants, all of whom were vaccine-eligible health professionals, were selected using a systematic random sampling procedure.

Outcome measures
The level of vaccine uptake in the study was determined by the proportion of health professionals who had received at least one dose of a COVID-19 vaccine.

Results
1251 health professionals participated, with 848 (67.8%) reporting that they had received at least one dose of a COVID-19 vaccine. Key findings from the multivariable logistic regression analysis revealed that health professionals aged 46 years and older were four times more likely to be vaccinated (95% CI, 1.656 to 9.510), married participants were 1.4 times more likely to take the vaccine (95% CI, 1.010 to 1.933) and those with good knowledge of COVID-19 vaccines were 1.75 times more likely to get vaccinated (95% CI, 1.307 to 2.331). Additionally, participants with a positive attitude towards vaccination were 3.65 times more likely to have received a vaccine (95% CI, 2.753 to 4.732).

Conclusions
The study reveals a commendable level of COVID-19 vaccine uptake among health professionals, emphasising their critical role in public health initiatives. However, the observed disparities in vaccination rates indicate the need for targeted interventions to improve vaccine coverage, particularly among younger professionals and those with limited knowledge of the vaccine. Addressing these gaps requires the implementation of tailored educational programmes that enhance understanding of COVID-19 vaccines. Furthermore, fostering positive attitudes through targeted campaigns, workplace-based initiatives and peer influence, particularly among younger and unmarried professionals, will be crucial. Encouraging vaccinated professionals to share their experiences and establishing regular follow-ups will also be essential strategies to improve vaccine acceptance and coverage in the region.

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Aprile 2025

Impacts on quality of care following electronic health record implementation within a large Canadian community hospital: a qualitative study

Objective
This study aimed to describe how healthcare providers perceived the impacts of implementing and using an electronic health record (EHR) on quality, safety and person-centredness of care.

Design
A qualitative descriptive design using semistructured interviews.

Setting
In October 2020, a large Canadian community hospital implemented a new EHR system (Epic) across three sites, transitioning from a previously fragmented (combination of paper-based and electronic) system.

Participants
Sixty-two healthcare providers and clinical leaders.

Results
Participants shared their experiences regarding the impact of EHR implementation on quality of care, which were analysed into common themes including task efficiency, information management, patient interactions and patient safety. While the system significantly altered their routines and introduced new responsibilities like additional documentation requirements, it also facilitated adherence to clinical guidelines, improved information visibility and enhanced documentation, benefiting overall quality of care and patient safety. Participants reported that EHR implementation led to increased efficiency, freeing up time for patient care and improving communication with patients and other providers.

Conclusion
EHRs have the potential to improve quality of care and patient safety, but this depends on their perceived value and how well healthcare providers can integrate their various features into clinical routines.

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Aprile 2025

ReNeuWell mental well-being app: protocol for a randomised controlled trial

Introduction
The field of mental well-being interventions includes numerous studies of smartphone app-based programs, but there is a research-to-retail gap where many studies pertain to apps that are not publicly available, not used as standalone programs, or not tested in the general population, and many publicly available apps (or their proprietary in-app measures) have yet to be submitted to empirical testing. Furthermore, few well-being apps offer multicomponent interventions, despite such interventions having demonstrated efficacy outside the smartphone context. In response to these openings in the literature and marketplace, we have developed ReNeuWell, an iPhone app designed to measure the user’s mental well-being (via the validated Composure, Own-worth, Mastery, Positivity, Achievement and Satisfaction for Well-being (COMPAS-W) scale) and improve their well-being via a personalised, multicomponent program of activities informed by the peer-reviewed evidence base. This article describes the protocol for the preregistered randomised controlled trial (RCT) of ReNeuWell, to test the app in adult participants from the general population of Apple App Store users. It is hypothesised that ReNeuWell users will experience significant increases in mental well-being and decreases in mental distress over the 6–12-week trial period, relative to users of an active control version of the app.

Methods and analysis
The RCT will recruit participants from Apple Store users who choose to download ReNeuWell in the normal course of browsing the marketplace. Following consent, the app will randomly allocate participants to receive either the full version of the app or the active control version. The full version assesses the user’s well-being via the validated COMPAS-W scale, provides feedback on their well-being across six dimensions and creates a personalised schedule of daily positive psychology activities designed to enhance well-being along each dimension. Participants will be instructed to use the app for at least 10 min (at least one activity) per day for the first 6 weeks, and as they wish for the following 6 weeks. Trial outcomes will be measured via in-app surveys administered in weeks 1, 6 and 12. Data collection will begin when the app is officially launched on the Apple Store. Data will be analysed using linear mixed models to estimate condition-by-time interaction effects on the primary and secondary outcomes, and to assess whether any such effects are themselves moderated by other key variables.

Ethics and dissemination
This protocol has been approved by the Human Research Ethics Committee of the University of New South Wales (reference number: HC210302). Trial outcomes will be published in accordance with the preregistered protocol described here, both in the peer-reviewed literature and on the registry website.

Trial registration number
This protocol was preregistered with the Australian New Zealand Clinical Trials Registry (registration approved on 4 August 2021; trial ID number: ACTRN12621001014842p).

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Aprile 2025