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Background: Dilated cardiomyopathy (DCM) is a leading cause of heart failure, particularly in younger individuals. Low physical strength is a global risk factor for cardiovascular mortality, and physical activity and a healthy lifestyle have been shown to improve outcomes in patients with heart failure. However, inappropriate exercise may increase the risk of arrhythmias in certain individuals with DCM. The determinants for predicting individual risks in this setting are poorly understood, and clinicians are hesitant to recommend sports for cardiomyopathy patients. The activeDCM trial aims to assess the safety and efficacy of a personalized exercise and activity programme for individuals with DCM., Study Design: The activeDCM trial is a prospective, randomized, interventional trial with a 12 month follow-up. Three hundred patients, aged 18-75 years with DCM, left ventricular ejection fraction (LVEF) ≤ 50% and New York Heart Association (NYHA) classes I-III, will be enrolled. The intervention includes a personalized exercise and activity programme. The primary outcome is the increase in peak oxygen uptake (VO 2 max, mL/kg/min) from baseline to 12 months. Secondary endpoints include adherence to personalized activity programmes, freedom from clinically relevant arrhythmia, unplanned hospitalization for heart failure and changes in NYHA class, quality of life scores, 6 min walk distance, muscular strength, N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity troponin T (hsTnT) levels and cardiac function. Advanced research questions include high-density phenome and omics analysis combined with digital biomarkers derived from Apple Watch devices., Discussion: The activeDCM trial will provide valuable insights into the safety and efficacy of personalized exercise training in DCM patients, inform clinical practice and contribute to the development of heart failure management programmes. The study will generate data on the impact of exercise on various aspects of cardiovascular disease, including genetic, metabolic, phenotypic and longitudinal aspects, facilitating the development of future digital tools and strategies, including the incorporation of smart wearable devices., (© 2024 The Author(s). ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: Integrated mental health care models that provide rapid access to video consultations with mental health specialists for primary care patients are a promising short-term, low-threshold treatment option and may reduce waiting times for specialist care. This qualitative study, nested within a randomized feasibility trial, aimed to explore participants' views on this type of care model, its influence on the lived experience of patients, and barriers and facilitators for its delivery., Methods: In five primary care practices, 50 adults with depression and/or anxiety were randomly assigned to either an integrated care model (maximum of five video consultations with a mental health specialist) or usual care (primary care or another treatment option). Prior to obtaining the trial results, interviews were held with participants who had received video consultations. Interviews were transcribed and analysed thematically., Results: Twenty of the 23 patients who received video consultations participated in the interviews. Patients engaged well with the care model and reported positive effects on their most pressing needs, while denying safety concerns. Generally, they perceived the usability of video consultations as high, and temporary connectivity failures were not considered a substantial barrier. We identified two key mechanisms of impacts on the patients' lived experience: fast access to specialist mental healthcare and the emerging rapport with the specialist. In particular, patients with no prior mental healthcare experience indicated that familiarity with the primary practice and their physician as a gatekeeper were important facilitators of proactive treatment., Conclusions: From the patients' perspective, mental health care models integrating video consultations with mental health specialists into primary care are linked to positive lived experiences. Our findings imply that primary care physicians should promote their role as gatekeepers to (1) actively engage patients, (2) apply integrated care models to provide a familiar and safe environment for conducting mental health care video consultations, and (3) be able to regularly assess whether certain patients need in-person services. Scaling up such models may be worthwhile in real-world service settings, where primary care physicians are faced with high workloads and limited specialist services., Trial Registration: DRKS00015812., (© 2023. The Author(s).)

The COVID-19 pandemic caused a major economic downturn that disproportionally affected university students. This empirical research investigated effects and risk factors of the pandemic on students' economic situation with focus on financial distress and financial limitations. Data was collected using an online survey in May and June 2020 from students (n = 917) enrolled at universities in Germany. 80.6% were enrolled in bachelor programs (n = 738), the mean semester was 3.8 (standard deviation (SD = 2.0) and students' mean age was 23.1 years (SD = 4.1). 51.8% (n = 472) were female and 47.4% (n = 432) male. 56.7% (n = 506) of students worked before the pandemic. More than one third reported a decrease in income (36.5%; n = 334) and an increase in financial constraints (38.7%; n = 354). A multivariate logistic regression analysis showed that students with regular income were less likely to experience financial distress compared to those without (odds ratio (OR) = 0.456; p = 0.014). Furthermore, working part-time as associated with a higher financial distress compared to those without part-time employment (OR = 1.811; p = 0.003). Students who worked part-time before the pandemic also had a higher probability of increased financial restriction (or constraint) compared to those who did not work part-time (OR = 2.094; p < 0.001). University students were disproportionally affected by the economic consequences of the COVID-19 pandemic, which increased students' economic uncertainty. To offset such problems, financial aid schemes for students need to be made available to alleviate distress and to allow students to focus on their studies but should not compound problems by leading to financial hardship at a later point in time., Competing Interests: The authors have declared that no competing interests exist.

The COVID-19 pandemic has severely affected physical and mental health. Since its commencement in 2020, social distancing has become the "new normal". Temporary lockdowns and distance learning have disproportionately affected young adults, including university students. To identify effects of the pandemic on university students' physical and mental health and learning, this empirical study included eight universities in Heidelberg, Mannheim and Ludwigshafen. Data was collected in May and June 2020. The self-administered survey was filled by 1,246 university students. 917 students completed the survey in full. 80.6% were bachelor students (n = 738), the mean semester was 3.8 and mean age was 23.1 years. 51.8% (n = 472) were female students and 47.4% (n = 432) male students. 38.5% (n = 352) stated a deterioration in physical health and 53.1% (n = 485) in mental health. From 0 to 10, students rated mean levels of stress highest due to social distancing (5.6), spending most time at home (5.0) and e-learning (4.5). Compared to male students, female students' mental health worsened significantly (58.7% vs. 46.8%). A logistic regression analysis identified gender having a significant effect on university students' stress levels: males seemed to have a lower risk of moderate to high levels of stress compared to females (odds ratio = 0.698; 95% CI = 0.515 to 0.945). Age, city of university and semester did not show a significant effect. The results are important to both regional and international audiences as university students face similar physical and mental health challenges due to the pandemic and its public health measures. Low-threshold initiatives are needed to mitigate the effects of the pandemic. These may include measures to reinforce students' locus of control, sense of belonging, relaxation and mindfulness as well as (online) counselling services. Gender-specific differences must be taken into account., Competing Interests: The authors have declared that no competing interests exist.

Objective: Despite available effective treatments for mental health disorders, few patients in need receive even the most basic care. Integrated telepsychiatry services may be a viable option to increase access to mental healthcare. The aim of this qualitative process evaluation embedded in a randomised controlled feasibility trial was to explore health providers' experiences with a mental healthcare model integrating mental health specialist video consultations (MHSVC) and primary care., Methods: A qualitative process evaluation focusing on MHSVC in primary care was conducted. In 13 semistructured interviews, we assessed the experience of all mental health specialists, primary care physicians and medical assistants who participated in the trial. A thematic analysis, focusing on the implementation, mechanisms of impact and context, was applied to investigate the data., Results: Considering (1) the implementation, participants evaluated the consultations as feasible, easy to use and time saving. Concerning (2) the mechanisms of impact, the consultations were regarded as effective for patients. Providers attributed the patients' improvements to two key aspects: the familiarity of the primary care practice and the fast access to specialist mental healthcare. Mental health specialists observed trustful therapeutic alliances emerging and described their experience as comparable to same-room care. However, compared with same-room care, specialists perceived the video consultations as more challenging and sometimes more exhausting due to the additional effort required for establishing therapeutic alliances. Regarding (3) the intervention's context, shorter travel distances for patients positively affected the implementation, while technical failures, that is, poor Internet connectivity, emerged as the main barrier., Conclusions: MHSVCs in primary care are feasible and successful in improving access to mental healthcare for patients. To optimise engagement and comfort of both patients and health providers, future work should focus on empirical determinants for establishing robust therapeutic alliances with patients receiving MHSVC (eg, leveraging non-verbal cues for therapeutic purposes)., Trial Registration Number: DRKS00015812; Results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Randomised controlled trials comparing robotic-assisted partial nephrectomy (RAPN) and open PN (OPN) are lacking. Therefore, we aim to report the study protocol and a trial update for a randomised controlled feasibility trial comparing RAPN versus OPN for renal neoplasms., Methods and Analysis: The ROBOtic assisted versus conventional Open Partial nephrectomy II trial is designed as a single-centre, randomised, open-label, feasibility trial. Participation will be offered to patients with renal neoplasms and deemed feasible for both, OPN and RAPN. We aim to enrol 50 patients within 15 months using a 1:1 allocation ratio. The primary endpoint of the trial is feasibility of recruitment and will be successful if one third of eligible patients agree to participate. Secondary endpoints include perioperative results, health-related quality of life, inflammatory response as well as surgical ergonomics of the operating team. If the primary outcome, feasibility of recruitment, is successful, the secondary results of the trial will be used for planning a confirmative phase III trial., Ethics and Dissemination: Ethical approval was obtained from the local institutional review board (Ethik-Kommission II at Heidelberg University: 2020-542N). Results will be made publicly available in peer-reviewed scientific journals and presented at appropriate congresses and social media., Trial Registration Number: NCT04534998., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Common mental disorders are one of the leading causes for sickness absence and early retirement due to reduced health. Furthermore, a treatment gap for common mental disorders has been described worldwide. Within this study, psychotherapeutic consultation at work defined as a tailored, module-based and work-related psychotherapeutic intervention will be applied to improve mental health care., Methods: This study comprises a randomised controlled multicentre trial with 1:1 allocation to an intervention and control group. In total, 520 employees with common mental disorders shall be recruited from companies being located around five study centres in Germany. Besides care as usual, the intervention group will receive up to 17 sessions of psychotherapy. The first session will include basics diagnostics and medical indication of treatment and the second session will include work-related diagnostics. Then, participants of the intervention group may receive work-related psychotherapeutic consultation for up to ten sessions. Further psychotherapeutic consultation during return to work for up to five sessions will be offered where appropriate. The control group will receive care as usual and the first intervention session of basic diagnostics and medical indication of treatment. After enrolment to the study, participants will be followed up after nine (first follow-up) and fifteen (second follow-up) months. Self-reported days of sickness absence within the last 6 months at the second follow-up will be used as the primary outcome and self-efficacy at the second follow-up as the secondary outcome. Furthermore, a cost-benefit assessment related to costs of common mental disorders for social insurances and companies will be performed., Discussion: Psychotherapeutic consultation at work represents a low threshold care model aiming to overcome treatment gaps for employees with common mental disorders. If successfully implemented and evaluated, it might serve as a role model to the care of employees with common mental disorders and might be adopted in standard care in cooperation with sickness and pension insurances in Germany., Trial Registration: The friaa project was registered at the German Clinical Trial Register (DRKS) at 01.03.2021 (DRKS00023049): https://www.drks.de/drks&#95;web/navigate.do?navigationId=trial.HTML&TRIAL&#95;ID=DRKS00023049 .

Background: Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients' reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care., Methods: In an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation., Discussion: To the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany., Trial Registration: ClinicalTrials.gov, United States National Institutes of Health NCT04316572 . Prospectively registered on 20 March 2020.