Search Results for: Demenze: trattamento farmacologico e non farmacologico e gestione dello stress del caregiver

Background
Minimally invasive approaches, including video-assisted thoracoscopic thymectomy (VATT) and robot-assisted thoracoscopic thymectomy (RATT), have emerged as alternatives to median sternotomy for resectable thymic epithelial tumours (TETs). However, their comparative clinical efficacy remains inconclusive due to limited prospective evidence. This phase II randomised controlled trial aims to provide the first direct comparative analysis of perioperative outcomes between RATT and VATT in stage I–II TETs.

Methods and analysis
This phase II clinical trial is a prospective, multicentre, randomised controlled study. A total of 100 patients with stage I–II TETs will be recruited and randomly allocated into two groups: RATT and VATT groups, with a 1:1 ratio. Follow-up visits will be scheduled at 1 month, 3 months and 6 months postsurgery, and semiannual visits will continue until November 2027, including the record of tumour recurrence, metastasis, survival outcomes and overall long-term effects. The primary endpoint is total postoperative thoracic drainage. Secondary outcomes encompass intraoperative factors like R0 resection rate, operative time, postoperative drainage duration, hospital stay length, conversion rates, levels of stress markers, pain scores, quality of life assessments, perioperative complication rates, mortality rates and 3-year disease-free and overall survival rates.

Ethics and dissemination
The study protocol is approved by the ethics committees of Zhongshan Hospital, Fudan University (No. B2024-365), and will be conducted under the guidance of the Helsinki Declaration. All data and findings will be disseminated and published through peer review.

Trial registration number
NCT06654830.

Introduction
Heart failure with preserved ejection fraction (HFpEF) is common and causes functional limitation, poor health-related quality of life (HRQoL) and impairs prognosis. Exercise-based cardiac rehabilitation is a promising intervention for HFpEF, but there is currently insufficient evidence to support its routine use. This trial will assess the clinical and cost-effectiveness of a 12-week health professional-facilitated, home-based rehabilitation intervention (REACH-HF), in people with HFpEF, for participants and their caregivers.

Methods and analysis
REACH-HFpEF is a parallel two group multicentre randomised controlled trial with 1:1 individual allocation to the REACH-HF intervention plus usual care (intervention group) or usual care alone (control group) with a target sample size of 372 participants with HFpEF and their caregivers recruited from secondary care centres in United Kingdom. Outcome assessment and statistical analysis will be performed blinded; outcomes will be assessed at baseline and 4-month and 12-month follow-up. The primary outcome measure will be patients’ disease-specific HRQoL, measured using the Minnesota Living with Heart Failure questionnaire, at 12 months. Secondary outcomes include patient’s exercise capacity, psychological well-being, level of physical activity, generic HRQoL, self-management, frailty, blood biomarkers, mortality, hospitalisations, and serious adverse events, and caregiver’s HRQoL and burden. A process evaluation and substudy will assess the fidelity of intervention delivery and adherence to the home-based exercise regime and explore potential mediators and moderators of changes in HRQoL with the intervention. Qualitative studies will describe facilitators’ experiences of delivery of the intervention. A cost-effectiveness analysis (CEA) of the REACH-HF intervention in participants with HFpEF will estimate incremental cost per quality-adjusted life year at 12 months. The CEA will be conducted from a UK NHS and Personal Social Services perspective and a wider societal perspective. The adequacy of trial recruitment in an initial 6-month internal pilot period will also be checked.

Ethics and dissemination
The study is approved by the West of Scotland Research Ethics Committee (ref 21/WS/0085). Results will be disseminated via peer-reviewed journal publication and conference presentations to researchers, service users and policymakers.

Trial registration number
ISRCTN47894539.

Circulation, Ahead of Print. BACKGROUND:Dilated cardiomyopathy (DCM) is substantially influenced by genetic factors. Sarcomere function is intricately associated with other organelles, particularly the reciprocal regulation between sarcomeres and mitochondria. Mitochondrial stress dysregulation is linked to DCM progression, yet mechanisms remain unclear. In this study, we investigated the effects of cTnT (cardiac troponin T) dysregulation on sarcomere–mitochondrial communication in DCM.METHODS:Induced pluripotent stem cells (iPSCs) derived from a DCM family cohort were used in this study, and CRISPR-Cas9 genome editing was used to rectify theTNNT2(c.A553G) sequence variation in iPSCs. A knock-in mouse model harboring the (p.K192E) sequence variation, equivalent to the human cTnT (p.K185E) sequence variation, was subsequently established. The pathological phenotypes were analyzed in iPSC-derived cardiomyocytes, iPSC-derived cardiac organoids, and mice. RNA sequencing, metabolite profiling, and coimmunoprecipitation mass spectrometry were used to elucidate the molecular mechanisms.RESULTS:Through whole exome sequencing, we identified a novel pathogenic variant in cTnT (p.K185E) as the causal sequence variation in a familial DCM cohort. In iPSC-derived cardiomyocytes from patients with DCM, we observed sarcomere disarray and mitochondrial fragmentation accompanied by severe mitochondrial dysfunction. The diminished interaction between cTnT (p.K185E) and 14-3-3 proteins resulted in the dissociation of 14-3-3 proteins from sarcomeric structures. The free 14-3-3 proteins aberrantly engaged in the RAS/RAF1 signaling axis, driving aberrant p44/42 kinase activation that culminated in the phosphorylation of mitochondrial fission regulators DRP1 (dynamin-related protein 1) and MFF (mitochondrial fission factor). These observations were replicated in iPSC-derived cardiac organoids. The knock-in mice bearing the orthologous cTnT sequence variation faithfully recapitulated the hallmark features of human DCM, including cardiac dysfunction, ventricular dilatation, sarcomeric disarray, and mitochondrial fragmentation. Mdivi-1, a mitochondrial fission inhibitor, alleviated DCM phenotypes in vivo.CONCLUSIONS:Our findings delineate a novel pathogenic mechanism underlying DCM, demonstrating that cTnT (p.K185E) sequence variation disrupts sarcomere–mitochondrial communication by weakening the interaction between cTnT and 14-3-3 proteins, thereby accelerating mitochondrial fragmentation through excessive activation of the 14-3-3 protein–mediated RAS/RAF1-p44/42-DRP1/MFF signaling axis. Therefore, therapeutic targeting of 14-3-3 proteins and p44/42 kinase activity may represent a promising strategy for DCM and other cardiac diseases associated with aberrant mitochondrial dynamics.

Objectives
This study aimed to explore the experience of online sexual abuse among school-going Bangladeshi youth.

Design
A convergent parallel mixed-method study. The quantitative strand employed a self-administered questionnaire survey conducted in classroom settings, while the qualitative strand used in-depth interviews guided by semistructured protocols. Data from both strands were analysed separately and then merged.

Participants and settings
Grade 9–10 students from four randomly selected schools in both an urban and a rural area of Bangladesh participated in the study. A total of 456 students participated in the quantitative survey, and 16 were subsequently interviewed for qualitative data.

Outcome measures
The frequency of online sexual abuse along with its contributing factors and patterns, including victim’s characteristics, perpetrator’s identity, potential avenue of abuse, knowledge and psychosocial consequences.

Results
About 88% of the participants reported using the Internet, and nearly 53% reported being victims of online sexual abuse at some point in their lives. The occurrence of common sexual abuses included online grooming (53%), cyberflashing (38%), sexting (35%), sexual solicitation (18%) and sextortion (12%) among Internet users. The odds of being sexually abused online were higher among urban children (OR=2.04, 95% CI 1.21–3.45), who spent more hours daily on the Internet (OR=1.09, 95% CI 1.01–1.18), who visited more social media (OR=1.42, 95% CI 1.27–1.59) and who used more Internet devices (OR=1.93, 95% CI 1.25–2.98). Many participants were aware of these incidents but did not know how to respond to online sexual abuse. Social media, chat groups and video games were described as primary avenues for abuse, while unemployed male young adults and partners in love affairs were identified as the possible perpetrators. Psychosocial consequences such as anxiety, depression, helplessness, stress, distrust, lack of concentration, social isolation, self-hate and suicidal attempts were reported by the victims. Encountering online sexual abuse also manifested in academic underperformance.

Conclusion
Urgent multisectoral measures are needed to address online sexual abuse to safeguard children’s right to be protected on online platforms.

All’ospedale ‘Mazzini’ di Teramo, eseguito intervento complesso

Introduction
Children discharged from hospital following management of complicated severe acute malnutrition (SAM) have a high risk of mortality, readmission and failed nutritional recovery. Current management approaches fail to sufficiently promote convalescence after inpatient nutritional rehabilitation. Novel interventions during the post-discharge period could enhance convalescence to help children survive and thrive.

Methods and analysis
The Co-SAM trial is an adaptive, multicountry, phase III, individually randomised clinical trial, based on the principles that (i) interacting biological and social factors drive multimorbidity in children with SAM, and (ii) both medical and psychosocial interventions may therefore ameliorate underlying causal pathways to reduce morbidity and mortality and improve recovery. Children aged 6–59 months with complicated SAM, who have stabilised and started the transition to ready-to-use therapeutic food (RUTF), will be enrolled and randomised to one of five trial arms (standard-of-care alone; antimicrobials; reformulated RUTF; psychosocial support; or a combination of all strategies). Standard-of-care, which is provided in all trial arms, includes RUTF until nutritional recovery (defined as weight-for-height Z-score >–2, mid-upper arm circumference >12.5 cm and oedema-free since the last study visit), and other management recommended in WHO guidelines. The 12-week antimicrobial package provides daily co-formulated rifampicin and isoniazid (with pyridoxine) and 3 days of azithromycin monthly. The reformulated RUTF, which incorporates medium-chain triglycerides and hydrolysed protein to increase nutrient bioavailability and reduce metabolic stress, is provided at the same dose and duration as standard RUTF. The 12-week psychosocial package includes caregiver problem-solving therapy, educational modules, peer support groups and child play. The combined arm includes all interventions. Children start their intervention package prior to hospital discharge, with follow-up data collection in study clinics at 2, 4, 6, 8, 12 and 24 weeks. The primary composite outcome is death, hospitalisation or failed nutritional recovery within 24 weeks post-randomisation. An interim analysis will allow unpromising arms to be dropped, while the final analysis will be conducted when 1266 children have completed the study. Embedded process evaluation and laboratory substudies will explore the mechanisms of action of the interventions.

Ethics and dissemination
The trial has been approved by ethics committees in Zimbabwe, Zambia, Kenya and UK. Dissemination will be via community advisory boards in each country; Ministries of Health; and dialogue with policymakers including UNICEF.

Trial registration number
Clinicaltrials.gov: NCT05994742; Pan African Clinical Trials Registry: PACTR202311478928378.

Objectives
To assess the demands for support measures of healthcare workers (HCWs) in China’s high-workload provinces during the COVID-19 pandemic and identify specific needs to make evidence-based recommendations.

Design
Prospective cross-sectional study.

Setting
Conducted in three Chinese provinces characterised by their significant healthcare demands during the pandemic.

Participants
The study comprised 683 HCWs, including doctors, nurses, resident physicians and hospital administrators. The sample was predominantly female (68.1%), with the majority aged between 25 and 34 years. Participants were recruited through convenience and snowball sampling methods, with a focus on individuals working in high-intensity clinical environments.

Results
Hierarchical analysis was performed to assess the layered impact of support measures across different roles and genders. Substantial gender disparity was observed, with female staff reporting significantly reduced access to material support (p

Background
Rapid urbanisation and the dense population of Bangladesh foster the growth of slum settlements, where poverty and food insecurity are magnified by economic instability and inflationary pressures, adversely affecting psychological health.

Objectives
This study aimed to assess household food security and its influence on psychological well-being among adults living in urban slums of Bangladesh.

Methods
A cross-sectional study using convenient sampling was conducted among 300 adults in slums in Dhaka, Bangladesh, using a semistructured questionnaire to collect data on sociodemographics, food security and mental health status. Multivariable logistic regression analyses were conducted to observe the influence of food insecurity on mental health status, controlling for other covariates.

Results
The majority of the participants experienced food insecurity, with 38.0% expressing severe food insecurity. High levels of psychological distress were observed, including stress (54.7%), anxiety (63.3%) and depression (73.3%). Older adults (aOR 4.5, 95% CI 1.3 to 15.5) and females (aOR 4.1, 95% CI 2.0 to 8.4) had higher odds of experiencing anxiety. Single individuals were more prone to experience depression, while homemakers exhibited elevated levels of both depression and anxiety. Furthermore, moderate to severe food insecurity was significantly associated with higher odds of depression (aOR 2.8, 95% CI 1.2 to 6.7) and anxiety (aOR 8.2, 95% CI 3.3 to 20.3) compared with no or mild food insecurity.

Conclusions
This study highlights the pervasive influence of household food insecurity on urban slum dwellers’ psychological well-being. Addressing vulnerabilities tied to age, marital status and occupation is crucial for alleviating mental health burdens.

Introduction
Post-traumatic stress disorder (PTSD) is a serious disorder that burdens individuals and society. The current standard of first-line treatment for PTSD is spaced trauma-focused treatment (S-TFT), involving weekly sessions. While effective, S-TFT may take relatively long to complete, especially in patients exposed to multiple potentially traumatic events (PTEs). Massed trauma-focused treatment (M-TFT), involving increased session frequency, potentially results in faster symptom reduction and restoration of quality of life, as well as in a reduction of societal costs. However, M-TFT is not recommended as first-line treatment. This paper describes the research protocol of a single-blind, multicentre randomised controlled trial (RCT) aimed at investigating: (1) the clinical and cost-effectiveness of M-TFT versus S-TFT in employed, multiply traumatised patients who seek first-line treatment for PTSD and (2) predictive and moderating factors related to treatment response.

Methods and analysis
186 participants are recruited from five centres and will be included if they are ≥18 years old, meet criteria for a Diagnostic and Statistical Manual of Mental Disorders Fifth Edition PTSD diagnosis based on ≥two PTEs, seek treatment for the first time and are employed. Patients with specified comorbid disorders and insufficient Dutch language proficiency are excluded. Participants are randomised to 800 min of either M-TFT or S-TFT. M-TFT consists of two once-weekly preparatory sessions, 10 twice-daily sessions of prolonged exposure, eye movement desensitisation and reprocessing therapy for 2 weeks and two once-weekly closing sessions. S-TFT consists of weekly sessions of one of five evidence-based treatment interventions. Outcomes are assessed at baseline and at 7 weeks, 17 weeks, 6 months and 9 months after baseline. Primary outcomes are clinical effectiveness in terms of PTSD symptom severity and cost-effectiveness based on quality of life measures and societal costs. Data will be analysed with linear mixed models.

Ethics and dissemination
This study protocol was approved by the Medical Ethics Review Board of the Amsterdam University Medical Center (NL86057.018.24). Participants will provide informed consent before enrolment in the trial. Results will be published in peer-reviewed journals and will be released to clinicians, patient groups and the general community.

Trial registration number
This protocol is registered at Overview of Medical Research in the Netherlands (OMON; trial register number 56960) and ClinicalTrials.gov (NCT06700590).

Stroke, Volume 56, Issue 6, Page 1650-1654, June 1, 2025. Evidence-based rehabilitation and secondary prevention interventions improve poststroke functional recovery and reduce secondary complications. However, stroke rehabilitation expertise, processes of care, and educational resources vary among sites where postacute care (PAC) is delivered. The American Heart Association developed quality standards based on the American Heart Association 2016 Guidelines for Adult Stroke Rehabilitation and Recovery to address these gaps. An interdisciplinary PAC standards writing committee identified key areas for PAC: quality improvement, medical management, care coordination, patient/caregiver and personnel education, and program management. Subgroups developed draft standards, combining results from a national landscape survey of PAC sites with clinical practice guidelines. The committee then refined the draft standards using a consensus-based process. American Heart Association staff and PAC sites in Montana convened a learning collaborative to gather feedback and provide gap analyses of the standards relative to current practices. Qualitative input from beta testing in Montana and quantitative results from the nationwide survey and Montana sites were analyzed and used to refine the standards further. The national landscape survey demonstrated that most sites do not meet the proposed standards: stroke program oversight structure (78% fall short), stroke rehabilitation leadership (70%), stroke-specific order sets/protocols (61%), and policies requiring staff stroke education (66%). Regarding Montana findings, 41% of the PAC sites have no mechanisms to identify areas of quality improvement specific to their stroke rehabilitation programs, and 59% do not use standardized tools to ensure that performance improvement initiatives are followed. However, with adequate support and resources, most Montana sites stated that they would be able to meet the proposed standards. We conclude that the Stroke PAC Quality Standards are applicable in PAC settings and provide a pathway to improving access to high-quality care for stroke survivors. Outcome studies are needed to confirm anticipated improvements in medical and functional outcomes.

Objectives
The aim of the present study was to examine the reliability and validity (structural and convergent) of the Resilience and Strain Questionnaire in Caregivers of People with Dementia (ResQ-Care-Dem).

Design
Cross-sectional survey study.

Setting
Online survey in Germany.

Participants
The ResQ-Care-Dem was completed by 243 informal caregivers of people with dementia (Mage=59.7 years, SD=10.9, 84.8% female).

Methods
The ResQ-Care-Dem consists of four scales: two resilience scales (psychological aspects and social aspects of resilience) and two burden scales (interpersonal burden and general burden). The reliability of the two resilience and two burden scales was assessed using Cronbach’s alpha as a measure of internal consistency. Structural validity was examined using a principal axis factor analysis. Convergent validity was assessed by Pearson’s correlations with the Zarit Burden Interview (ZBI-7), the Caregiver Self-Efficacy Scale (CES-8) and the Gain in Alzheimer Care Instrument (GAIN).

Results
The ResQ-Care-Dem scales’ internal consistencies ranged between 0.65 and 0.81. The factorial structure could partly be confirmed, with the items of the four scales primarily loading on four factors. The burden scales demonstrated high and positive correlations with the score for caregiver burden (ZBI-7, r=0.51 – 0.55) and small to high, negative correlations with the scores for caregiver self-efficacy (CES-8, r=–0.52 –0.56) and gains from caregiving (GAIN, r=–0.21 –0.22), supporting construct validity of the scales. The resilience scales showed small to high positive correlations with the scores for caregiver self-efficacy (CES-8, r=0.50 – 0.57) and gains from caregiving (GAIN, r=0.27 – 0.50), as well as moderate negative correlations with the caregiver burden score (ZBI-7, r=–0.45 –0.50), providing evidence for the scales’ construct validity.

Conclusions
The reliability and structural validity of the ResQ-Care-Dem were partially confirmed. Evidence supporting its convergent validity suggests that the questionnaire has potential as a tool for assessing caregiver burden and resilience factors among informal caregivers of people with dementia. While these findings indicate potential practical applicability, future studies should investigate its performance in real-world settings and assess changes over time (eg, responsiveness) in longitudinal studies.

Introduction
Mental health is essential for well-being and critical to the quality of care delivered by healthcare professionals. Health workers face increased risks of mental health disorders due to long hours, high emotional and physical demands, and exposure to communicable diseases, which exacerbate stress and anxiety levels. Evidence from low-income countries, including Mozambique, is scarce, yet health professionals in these regions frequently deal with the dual burden of communicable diseases and resource constraints. This study addresses a critical evidence gap by focusing on the mental health of healthcare professionals in Mozambique who are frequently exposed to psychological stress while managing communicable diseases. It aims to assess the prevalence of stress, anxiety and depression among healthcare workers providing services related to communicable diseases in primary-level health units (PHUs) in Maputo City, Mozambique. The study also seeks to identify personal and professional factors associated with these mental health disorders.

Methods and analysis
This is an observational cross-sectional study targeting healthcare workers in PHUs who provide services related to communicable diseases in Maputo City. Using convenience sampling, 382 participants will be recruited, stratified by health unit type. This sample size was calculated manually using the formula by Wang and Ji (2020). Data will be collected through a questionnaire, including demographic and professional information and a validated tool (Depression, Anxiety and Stress Scale, DASS-21), using the Research Electronic Data Capture (REDCap) Software for secure data capture. Descriptive and inferential statistical analyses will be performed using IBM SPSS Statistics to estimate prevalence rates and explore associated factors.

Ethics and dissemination
The study was approved by the Interinstitutional Committee on Bioethics in Health of the Faculty of Medicine/Maputo Central Hospital (CIBS FM&HCM/117/2024). Written informed consent will be obtained, and participants experiencing significant discomfort will be referred for mental health support. Findings will be disseminated via academic theses, peer-reviewed publications, national conferences, and reports shared with the Ministry of Health to inform mental health interventions for healthcare workers.

Registration
This protocol is registered with the Interinstitutional Committee on Bioethics in Health of the Faculty of Medicine/Maputo Central Hospital (CIBS FM&HCM).

Introduction
Stroke is a leading cause of death and disability worldwide. Stroke survivors and their caregivers often face profound social isolation and various participation restrictions, resulting in frustration and adverse health outcomes. Dyad-focused interventions, which address both survivor and caregiver needs, are essential during the transition process. However, few interventions equally prioritise the outcomes of both survivors and caregivers. This study aims to evaluate the efficacy of a newly developed dyad-focused strategy training intervention in enhancing participation among stroke survivors and their caregivers.

Methods and analysis
This study employs a single-blind, parallel-group randomised controlled trial with allocation concealment and assessor blinding. We aim to enrol 138 stroke survivor-caregiver dyads, randomly assigned in a 1:1 ratio to either the experimental intervention group or the control group. Both groups will receive their usual rehabilitation plus 45–60 min sessions of the intervention twice weekly for a total of 12 sessions. Outcome measures, including the Participation Measure-3 Domains, 4 Dimensions, General Self-Efficacy Scale and Activity Measure for Post-Acute Care, will be collected at baseline, post-intervention and at 3-month, 6-month and 12-month follow-ups. Data will be analysed using multiple linear regression and mixed-effects regression models. Qualitative indepth interviews with participants, caregivers and therapists will be conducted post intervention, transcribed and thematically analysed.

Ethics and dissemination
Ethics approval was obtained from the Ethics Committee of Taipei Medical University (approval number: N202203083), National Taiwan University Hospital (approval number: 202207096RINA) and Taipei Tzu Chi Hospital (approval number: 11 M-107). Findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals.

Trial registration number
NCT05571150; Preresults.