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Conventional and tablet-supported physical training to reduce falls and fall-related injuries in community-dwelling older adults: protocol of the randomised SURE-footed into the future Fall Intervention Trial (SURE-FIT)

Por: Schoene · D. · Gross · M. · Finger · B. · Lahmann · N. A. · Raeder · K. · Vorwerg-Gall · S. · König · H.-H. · Grochtdreis · T. · Stöger · D. · Handschuh · A. · Unseld · T. · Rothenbacher · D. · Büchele · G. · Rapp · K.
Introduction

Exercise-based interventions are well-established in reducing falls and fall-related injuries, but adherence and accessibility remain key challenges, particularly in rural areas. While conventional in-person training is widely used, digital interventions may offer scalable solutions to enhance engagement and reach. However, pragmatic trials evaluating the real-world effectiveness of conventional and digitally supported fall prevention interventions are lacking, limiting the evidence base for their implementation in routine healthcare settings. The SURE-Footed into the Future Fall Intervention Trial (SURE-FIT) aims to compare the effectiveness of two structured fall prevention interventions—a conventional centre-based exercise programme and a hybrid telemedical programme combining in-person and tablet-supported training—against a wait-list control group in reducing falls and fall-related injuries among community-dwelling older adults.

Methods and analysis

This study is a pragmatic three-arm, parallel-group, randomised controlled superiority trial with a 1:1:1 allocation ratio. Participants (≥65 years, community-dwelling, planned n=2778) will be randomly assigned to (1) conventional centre-based training supplemented with printed materials for home-based continuation (conventional group), (2) a hybrid model integrating centre-based and tablet-supported training for continuation (tablet group) or (3) a wait-list control group. The intervention includes a 9-week supervised phase followed by 43 weeks of independent home-based training. The primary outcomes are the incidence rate of falls and fall-related injuries over 12 months. Secondary outcomes include physical functioning, physical activity, concerns about falling, loneliness and the risk of low protein intake. A process evaluation will assess intervention feasibility and implementation. Additionally, qualitative interviews will be conducted with participants, course instructors and municipal stakeholders to explore experiences, facilitators and challenges related to programme participation and implementation. A health-economic evaluation will be conducted to assess the cost-effectiveness of the structured fall prevention interventions. Data collection will take place at baseline and every 3 months via standardised questionnaires, with a subgroup undergoing physical performance testing and sensor-based activity monitoring. Analyses will follow an intention-to-treat approach.

Ethics and dissemination

Ethical approval has been granted by the Ethics Committee of Ulm University (271/23). Written informed consent will be obtained from all participants before enrolment. Study findings will be disseminated through peer-reviewed publications, scientific conferences and national fall prevention initiatives. Additionally, results will be shared with key municipal representatives, and the German National Association of Senior Citizens’ Organisations (BAGSO). A publicly accessible website will provide ongoing access to study information and findings in plain language.

Trial registration number

DRKS00032878, German Clinical Trials Register

Effectiveness of an internet-based self-help intervention for improving mental health in individuals with obesity: study protocol for a randomised controlled trial

Por: Schladitz · K. · Buss · A. · Pabst · A. · Welzel · F. D. · Blüher · M. · Stumvoll · M. · Brettschneider · C. · König · H.-H. · Riedel-Heller · S. G. · Löbner · M.
Introduction

Patients with chronic somatic diseases such as obesity often develop comorbid depressive symptoms. E-mental health interventions are an innovative and effective treatment option within a stepped care approach. Studies have shown that acceptance and adherence are higher when they are tailored to the specific needs of the target group. This study protocol describes a randomised controlled trial (RCT) of an internet-based self-help intervention, Fit4Mood, to improve mental health in the high-risk group of adults with obesity. The objective of the @ktivPLUS research project is to evaluate the effectiveness, acceptability and cost-effectiveness of the intervention in comparison to an online bibliotherapy.

Methods and analysis

Eligible individuals will be randomly allocated to an intervention group (access to an internet-based intervention) or to an active control group (access to an online bibliotherapy). Assessments will be conducted before the start of the intervention (baseline (BL)) and 4 months after BL (follow-up (FU)). The primary outcome is the reduction in depressive symptoms (Beck Depression Inventory-II) in n=190 participants. Secondary outcomes are anxiety, quality of life, activity, self-efficacy, resilience, mental and digital health literacy, stress, sleep quality, weight loss, weight management activities and readiness to lose weight, weight self-stigma, uptake, adherence and satisfaction with the intervention, workability and cost-effectiveness at follow-up. Additionally, sociodemographics, health, comorbidities and disabilities, as well as internet-specific information, will be assessed at BL. Intention-to-treat analysis using generalised linear mixed models will be applied.

Ethics and dissemination

Approval for this study has been granted by the ethics committee of the University of Leipzig (ID: 140/25-ek). All participants will provide informed consent prior to participation in the study. Results will be disseminated in peer-reviewed journals and presented at national and international conferences. In the case of a successful evaluation, the internet-based self-help intervention Fit4Mood will be provided as freeware, which will be easily accessible and free of charge.

Trial registration number

The current RCT study has been registered at the German Clinical Trials Register (Identifier: DRKS00036178, Registered 24 June 2025; https://www.drks.de/search/de/trial/DRKS00036178).

Predictors, mediators, effect modifiers and preventive actions regarding secondary school teacher burnout, anxiety and depression--protocol for a systematic scoping review

Por: König · M. · Wallraff · J. P. · Glenewinkel · F. · Wild · U. · Erren · T. C. · Lewis · P.
Introduction

The teaching profession plays a crucial role in society. From educating and forming future generations to fulfilling various administrative tasks and managing expectations and experiences that reach beyond the classroom—teachers face immense demands on their time, energy, and emotional resources. Consequently, they are subject to high work burden. This is reflected in the high prevalence of burnout, anxiety, and depression among teachers. A scoping review of factors associated with these outcomes in teachers is required to inform the further development of preventive occupational medicine strategies. In this scoping review, we aim to (i) identify and (ii) appraise the factors (eg, workplace, environmental, lifestyle, psychological) associated with burnout, anxiety, and depression specific to secondary school teachers and to (iii) synthesise the findings from the perspective of preventive occupational medicine.

Methods and analysis

The scoping review will be performed following the PRISMA extension for Scoping Reviews guidance. A systematic literature search will be conducted in the Medline, Web of Science Core Collection, PsychInfo, and Cochrane Library databases using search terms pertinent to secondary school teachers as the population of interest and depression, anxiety, and burnout as the outcomes of interest. Returned articles from the database search published pre-2017 will be excluded for the following reasons; namely, (a) that current literature will more closely reflect the current demands of the teachers, (b) the timing fits with recent systematic reviews highlighting burnout, anxiety, and depression as major problems among teachers, and (c) it facilitates feasibility of review in terms of the volume of studies. Remaining records will then be deduplicated and screened against predefined eligibility criteria that also add focus on teachers and these outcomes. Relevant data concerning factors associated with burnout, anxiety, and depression in teachers will be extracted and mapped. A narrative appraisal of included studies will be employed that will be specific to the validity of the results regarding factors (exposures, mediators, effect modifiers) that may affect the outcomes of interest (as opposed to more generic appraisal of the entirety of individual articles). Findings will be narratively synthesised from the perspective of preventive occupational medicine.

Ethics and dissemination

Formal ethical approval is not required as primary data will not be collected in this study. The findings of this study will be disseminated through peer-reviewed publication, conference presentation, and condensed summaries for key stakeholders and partners in the field (including teachers, schools, and governing bodies).

Registration details

The protocol was registered on the Open Science Framework on 26.06.2025 and can be identified using the following link: https://doi.org/10.17605/OSF.IO/BKX56.

Heidelberg Perioperative Deep Data Study (HeiPoDD): study protocol for a prospective cohort study for prediction of complications after high-risk non-cardiac surgery in a German university hospital

Por: Jung-König · M. · Hölzer · H. T. · Tenckhoff · S. · Kumar · S. · Etheredge · M. · Schaack · D. · Hölle · T. · Schuster · L. C. · Nusshag · C. · Rath · M. · Uhl · C. · Pianka · F. · Michalski · C. W. · Hohenfellner · M. · Arif · R. · Karck · M. · Böckler · D. · Probst · P. · Diener
Introduction

Perioperative adverse events increase morbidity and mortality. The rate and severity of complications and the risk for subsequent mortality are increased after high-risk procedures and in elevated-risk patients. Over the past decades, a multitude of prognostic studies identified perioperative risk factors at the population level. However, to allow for the advancement of precision surgery strategies, improved risk prediction on the individual patient level is warranted. Comprehensive, consecutive, multisource, structured, high-quality patient-related and procedure-related data sets, together with thorough follow-up and combined with state-of-the-art machine-learning analyses, are needed to facilitate precise prediction of perioperative complications. Therefore, we designed and currently conduct the Heidelberg Perioperative Deep Data study (HeiPoDD). Here, we report the rationale and design of the HeiPoDD study.

Methods and analysis

HeiPoDD is a prospective, single-centre, exploratory cohort study aiming to build up a large-scale deep-data base and corresponding biomaterial collection. 1040 adult patients planned for elective high-risk, non-cardiac surgery for any indication at Heidelberg University Hospital, Germany will be included. The obtained study-specific data set includes clinical data, lab values, genome- and proteome analysis as well as plasma, serum and peripheral blood mononuclear cells (PBMC) collected before and at days 1, 3 and 7 postsurgery. Urine samples are collected before and at day 1 postsurgery. Structured follow-up for perioperative complications such as redo-surgery, length of intensive care stay or length of hospital stay is conducted at days 30, 90 and 1 year postsurgery and for disease progression and survival after 3 and 5 years postsurgery. All study data will be transferred to the HeiPoDD registry to allow merging with all available routine clinical data from the hospital information system including imaging studies as well as haemodynamic and respiratory biosignals. Biomaterials will be stored in the HeiPoDD biomaterial bank to allow further analyses.

Ethics and dissemination

The trial protocol and amendments were approved by the ethics committee of the University of Heidelberg (S-758/2021). The protocol is registered with the German Clinical Trial Register (DRKS00024625). Participating patients’ data will be recorded only in pseudonymised form. After completion of the study, data collected during the study will be kept on file for up to 30 years. Biomedical samples collected during the study and entered into the biobank will be held for the same amount of time. The findings will be disseminated in peer-reviewed academic journals.

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