Abstract Background Delirium is a frequent and serious neuropsychiatric syndrome in older adults. People living with dementia are at particularly high risk of developing delirium. In nursing homes, where dementia prevalence is high, delirium superimposed on dementia (DSD) represents a major clinical challenge and research gap. Aim of the study is to produce reliable data on prevalence and incidence of DSD in nursing homes as well as to investigate risk factors, clinical course, physical activity patterns, and care processes. Methods This prospective multicenter cohort study will be conducted between August 2025 and July 2028 in three regions in northwestern Germany. Approximately 300 residents with dementia from about 20 nursing homes will be enrolled. Participants without DSD at baseline will undergo weekly delirium screening over six months using the Informant Assessment of Geriatric Delirium (I-AGeD), administered by trained research staff. In cases of positive screening, delirium severity and motor subtype will be assessed using the Delirium Rating Scale-Revised-98 (DRS-R-98) and Delirium Motor Subtype Scale (DMSS). Nursing and medical care processes related to delirium will be documented upon first occurrence of potential DSD. Physical activity will be assessed at baseline and reassessed at the first occurrence of potential DSD or, in participants without delirium, at the end of the six-month observation period. Prevalence and incidence of delirium will be estimated with adjustment for clustering at the nursing home level. Risk factors will be analyzed using multiple mixed logistic regression models, and time-to-event analyses will be applied for incident delirium. Explorative prognostic analyses will examine associations with cognitive decline, functional status, mortality, and physical activity. Discussion Findings will inform development of context-sensitive prevention and management strategies to strengthen evidence-based delirium care in nursing homes. Trial registration Prospectively registered on 17.04.2026 in the Deutsches Register für Klinische Studien (DRKS), (DRKS00039239; Date of registration in DRKS: 2026-04-17).

To identify ICD-10-GM codes recorded in the year preceding a Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) diagnosis, we conducted a 1:5 matched case–control study using statutory health insurance data of 6–27-year-olds with ME/CFS (ICD-10-GM: G93.3, 2020–2022). Cases (n = 6,077) were matched 1:5 to controls by birth year, sex, and postal code. ICD-10-GM codes from the preceding year were analyzed using multivariable conditional logistic regression, reporting odds ratios (OR) and 95% confidence intervals. Most cases were female and aged 18–27 years. Forty-four ICD-10-GM code classes were associated with increased and four with decreased odds, spanning 13 diagnostic chapters. Most associations were in chapters F (mental/behavioral disorders), R (respiratory diseases), and M (musculoskeletal disorders). Frequent conditions included fatigue, depression, pain disorders, and somatoform disorders (≥ 10% in cases; ORs 1.11–2.19. Rare diagnoses (≤ 1% prevalence), such as fibromyalgia (OR 2.08, 95% CI: 1.20–3.59) and mild cognitive impairment (2.93, 1.21–7.10), were strongly associated. Four COVID-19 or vaccination-related code classes were identified, with post-COVID-19 condition showing the highest OR (3.84, 2.97–4.98). Several ICD-10-GM codes, including COVID-19 related codes, were associated with later ME/CFS diagnoses. Prospective studies should clarify timing relative to ME/CFS onset, and distinguish between pre-existing conditions, comorbidities, early manifestations, or misdiagnoses.

BackgroundCancer patients with minor children but also their families suffer from significant psychological distress and comorbidity. Protective factors predicting successful coping are well known. Corresponding systematic interventions are rare and limited by access barriers. We developed a comprehensive family-centered intervention for cancer patients with at least one dependent minor.Patients and methodsFamily-SCOUT represents a multicentric, prospective, interventional, and controlled study for families with parental cancer and their minor children. In the intervention group (IG), all family members were addressed using a care and case management approach for nine months. Families in the control group (CG) received standard of care. Participating parents were asked to complete the Hospital-Anxiety-Depression-Scale (HADS) questionnaire at enrolment (T0) and after 9 months (T2). The primary outcome was a clinically relevant reduction of distress in at least one parent per family, measured as minimal important difference (MID) of ≥1.6 in the HADS total score. The percentage of families achieving MID is compared between the IG and CG by exact Fisher’s test, followed by multivariate confounder analyses.ResultsT0-questionnaire of at least one parent was available for 424 of 472 participating families, T2-questionnaire after 9 months was available for 331 families (IG n = 175, CG n = 156). At baseline, both parents showed high levels of distress (HADS total: sick parents IG: 18.7 ± 8.1; CG: 16.0 ± 7.2; healthy partners: IG: 19.1 ± 7.9; CG: 15.2 ± 7.7). The intervention was associated with a significant reduction in parental distress in the IG (MID 70.4% in at least one parent) compared with the CG (MID 55.8%; P = 0.008). Adjustment for group differences from specific confounders retained significance (P = 0.047). Bias from other confounders cannot be excluded.ConclusionsParental cancer leads to a high psychosocial burden in affected families. Significant distress reduction can be achieved through an optimized and structured care approach directed at the family level such as family-SCOUT.

OBJECTIVE:Children in families with parental cancer may experience emotional, social or physical problems. The aims are to analyze child, parent and family-based determinants of children's health-related quality of life (HRQoL) and their experiences of parental cancer. METHODS:As part of a mixed-methods, multicenter, prospective, interventional non-randomized study "Family-SCOUT," a family-centered intervention in the form of care and case management was developed. Children's HRQoL (KIDSCREEN-10) was assessed at baseline (study inclusion). Descriptive analyses and family cluster-adjusted linear mixed models were performed. Qualitative coding of children's experiences reported in an open-ended text field of the questionnaire was performed. RESULTS:Four hundred and seventy-two families with 472 parents with cancer and 649 children were included in the study of which N = 346 were analyzed. The average age of the children was 12.8 years. 48% of the children were female. Family cluster-adjusted mixed linear model showed significant associations between children's HRQoL (dependent variable) and children's age (-0.44, p = 0.023, 95%-CI = -0.82 to -0.06) and between families (ICCnull model = 0.377, Pseudo-R2 = 0.443). Children experienced changes in the family situation, such as daily routines and communication among all family members, death of a parent, COVID-19-related difficulties, and supportive social relationships. CONCLUSIONS:Child, parent and family-based factors appear to be related to children's HRQoL. Research on children's HRQoL and experiences in the context of parental cancer underscores the need for a multidimensional and family-based approach to support these children.

Abstract Introduction Digital mental health interventions (DMHIs) have been shown to be effective in the prevention and treatment of common mental disorders (CMDs). Low utilization - often based on lacking awareness or familiarity with DMHIs - should be addressed by user-centered, context-sensitive information strategies. Concerning information strategies, medical students are a particularly interesting target group, as they belong to a vulnerable group in terms of a relatively high prevalence of CMDs and, moreover, will be able to prescribe DMHIs as future physicians. Methods A discrete-choice experiment (DCE) was conducted to study information preferences among medical students in Germany. Attributes (information source, delivery mode, timing, recommendation, and quality criterion) were developed by a sequential mixed-method approach. Conditional logistic regression analysis was employed to estimate preference weights and relative importance of attributes (ethical approval: no. 2022-2102). Results Out of n=231 participants (70% women, age: M=24, SD=3.95), 29.49% indicated being familiar with DMHIs. Medical students preferred to receive information about DMHIs from the student council and favored being informed via social media during their pre-clinic phase or in their freshmen week. Recommendations were preferred if given by other students or health professionals. Evidence base is the preferred quality criterion. Overall, timing of information provision was the most relevant attribute. Discussion Timing appears to be the most important factor for DMHI information, which calls for action early in medical education. Conclusion Based on the findings of the DCE, a comprehensive information strategy is deduced that allows to inform medical students by their preferred information strategy.

BackgroundDigital mental health interventions (DMHIs) are capable of closing gaps in the prevention and therapy of common mental disorders. Despite their proven effectiveness and approval for prescription, use rates remain low. The reasons include a lack of familiarity and knowledge as well as lasting concerns. Medical students were shown to have a comparatively higher risk for common mental disorders and are thus an important target group for raising awareness about DMHIs. At best, knowledge is already imparted during medical school using context-sensitive information strategies. Yet, little is known about medical students’ information preferences regarding DMHIs. ObjectiveThis study aims to explore information preferences for DMHIs for personal use among medical students in Germany. MethodsA discrete choice experiment was conducted, which was developed using an exploratory sequential mixed methods research approach. In total, 5 attributes (ie, source, delivery mode, timing, recommendation, and quality criteria), each with 3 to 4 levels, were identified using formative research. Data were analyzed using logistic regression models to estimate preference weights and the relative importance of attributes. To identify subgroups of students varying in information preferences, we additionally performed a latent class analysis. ResultsOf 309 participants, 231 (74.8%) with reliable data were included in the main analysis (women: 217/309, 70.2%; age: mean 24.1, SD 4.0 y). Overall, the conditional logit model revealed that medical students preferred to receive information about DMHIs from the student council and favored being informed via social media early (ie, during their preclinic phase or their freshman week). Recommendations from other students or health professionals were preferred over recommendations from other users or no recommendations at all. Information about the scientific evidence base was the preferred quality criterion. Overall, the timing of information was the most relevant attribute (32.6%). Latent class analysis revealed 2 distinct subgroups. Class 1 preferred to receive extensive information about DMHIs in a seminar, while class 2 wanted to be informed digitally (via email or social media) and as early as possible in their studies. ConclusionsMedical students reported specific needs and preferences regarding DMHI information provided in medical school. Overall, the timing of information (early in medical education) was considered more important than the information source or delivery mode, which should be prioritized by decision makers (eg, members of faculties of medicine, universities, and ministries of education). Study findings suggest general and subgroup-specific information strategies, which could be implemented in a stepped approach. Easily accessible digital information may promote students’ interest in DMHIs in the first step that might lead to further information-seeking behavior and the attendance of seminars about DMHIs in the second step.

OBJECTIVE:To reduce sleep problems in people living with dementia using a multi-component intervention. DESIGN:Cluster-randomized controlled study with two parallel groups and a follow-up of 16 weeks. SETTING:Using external concealed randomization, 24 nursing homes (NH) were allocated either to the intervention group (IG, 12 clusters, 126 participants) or the control group (12 clusters, 116 participants). PARTICIPANTS:Participants were eligible if they had dementia or severe cognitive impairment, at least two sleep problems, and residence of at least two weeks in a NH. INTERVENTION:The 16-week intervention consists of six components: (1) assessment of sleep-promoting activities and environmental factors in NHs, (2) implementation of two "sleep nurses," (3) basic education, (4) advanced education for staff, (5) workshops to develop sleep-promoting concepts, and (6) written information and education materials. The control group (CG) received standard care. MEASUREMENTS:Primary outcome was ≥ two sleep problems after 16 weeks assessed with the Sleep Disorders Inventory (SDI). RESULTS:Twenty-two clusters (IG = 10, CG = 12) with 191 participants completed the study. At baseline, 90% of people living with dementia in the IG and 93% in the CG had at least two sleep problems. After 16 weeks, rates were 59.3% (IG) vs 83.8% (CG), respectively, a difference of -24.5% (95% CI, -46.3% - -2.7%; cluster-adjusted odds ratio 0.281; 95% CI 0.087-0.909). Secondary outcomes showed a significant difference only for SDI scores after eight and 16 weeks. CONCLUSIONS:The MoNoPol-Sleep intervention reduced sleep problems of people living with dementia in NH compared to standard care.

PURPOSE:This study aimed to assess the feasibility of a comprehensive psychosocial intervention for families coping with parental cancer. METHODS:A quasi-experimental trial with intervention and control group, employing a mixed-methods approach, was conducted. A total of 472 families affected by parental cancer participated. The feasibility of the intervention was evaluated based on study monitoring measures (on-site visits, team supervision meeting observations, case conference observations, best practice workshops, coordinating information exchange between intervention sites, and reviewing intervention documentation), process evaluation (semi-structured interviews, focus group discussion) and survey data. Data analysis involved thematic coding and descriptive statistics. RESULTS:The intervention was well-received by the participating families, with a high degree of acceptance observed. The feasibility of the intervention was found to be associated with specific dynamics within each family system and the motivation of the family members. The success of the intervention was described as dependent on the family-centered arrangement of the encounters, including factors such as frequency, duration, and mode, which greatly influenced its overall acceptability. CONCLUSION:The family-scout intervention demonstrates its feasibility as an effective intervention to reduce the burden experienced by families coping with parental cancer. Psychosocial oncology services should continue to develop and implement family-centered interventions to offer support to families during their cancer journey. TRIAL REGISTRATION:ClinicalTrials.gov, NCT04186923. Retrospectively registered on 4 December 2019.

ABSTRACT Purpose Pain is a common symptom following proximal femoral fractures (PFF), however, information on its treatment in terms of agents and type of use (scheduled vs. pro re nata [PRN]) is scarce. The main objective of this study was to examine pain medication regimens according to pain intensity following PFF. Furthermore, we explored the utilization of medication plans. Methods The “ProFem”‐study on healthcare provision, functional ability, and quality of life after PFF is a German population‐based prospective cohort study based on statutory health insurance data and individually linked survey data from different time points including information on the currently used medication. This present analysis refers to the participants' baseline interviews (about 3 months following PFF) conducted from 2018 to 2019 in the participants' private surroundings. Results The study population comprised 444 participants (mean age: 81.2 years, 71.0% female). Half of them reported high intensity pain, and the mean value for the EuroQol visual analogue scale was 50.8. Most commonly used analgesics were metamizole and tilidine/naloxone. Among participants with high intensity pain, 21.9% received only PRN pain medication and 17.2% no pain medication at all. Overall, 61.5% of participants presented any (printed) medication plan and only 25.2% a “federal standardized medication plan” (BMP). Conclusion As a substantial number of patients reports high intensity pain about 3 months following a PFF, the large proportion of those receiving no or only PRN pain medication raises questions regarding the appropriateness of the therapy. The overall low utilization of the BMP indicates potential for improvement.

We examined incidence rates (IR) for all distal radius fracture (DRF) events based on inpatient and outpatient data from a large statutory health insurance in Germany. Of all DRF, 56

Background: There is limited research into the effects of the birth environment on birth outcomes. Aim: To investigate the effect of a hospital birthing room designed to encourage mobility, self-determination and uptake of upright maternal positions in labour on the rate of vaginal births.Methods: The multicentre randomised controlled trial Be-Up, conducted from April 2018 to May 2021 in 22 hospitals in Germany, included 3719 pregnant women with a singleton pregnancy in cephalic position at term. In the intervention birthing room, the bed was removed or covered in a corner of the room and materials were provided to promote upright maternal positions, physical mobility and self-determination. No changes were made in the control birthing room.The primary outcome was probability of vaginal births; secondary outcomes were episiotomy, perineal tears degree 3 and 4, epidural anaesthesia, "critical outcome of newborns at term", and maternal self-determination (LAS). Analysis: intention-to-treat.Findings: The rate of vaginal births was 89.1 % (95 % CI 87.5-90.4%; n = 1836) in the intervention group and 88.5 % (95 % CI 87.0-89.9 %; n = 1863) in the control group. The risk difference in the probability of vaginal birth was + 0.54 % (95 % CI -1.49 % to 2.57 %), the odds ratio was 1.06 (95 % CI 0.86-1.30). Neither the secondary endpoints nor serious adverse events showed significant differences. Regardless of group assignment, there was a significant association between upright maternal body position and maternal self-determination.Conclusion: The increased vaginal birth rates in both comparison groups can be explained by the high motivation of the women and the staff.

BACKGROUND:Most randomised controlled trials on advance care planning were conducted in people with advanced, life-limiting illnesses or in institutional settings. There are few studies on its effect in older people living in the community.AIM:To determine the effects of advance care planning in older community dwelling people.DESIGN:The STADPLAN study was a cluster-randomised trial with 12 months follow-up. The complex intervention comprised a 2-days training for nurse facilitators that delivered a formal advance care planning counselling and a written information brochure. Patients in the control group received optimised usual care, that is, provision of a short information brochure.SETTING/PARTICIPANTS:Home care services in three regions of Germany were randomised using concealed allocation. Care dependent clients of participating home care services, aged 60 years or older, and rated to have a life-expectancy of at least 4 weeks were included. Primary outcome was active participation in care at 12 months, assessed by blinded investigators using the Patient Activation Measure (PAM-13).RESULTS:Twenty-seven home care services and 380 patients took part. Three hundred seventy-three patients were included in the primary analysis (n = 206 in the intervention and n = 167 in the control group). There was no statistically significant difference between the intervention and control group with regard to the PAM-13 after 12 months (75.7 vs 78.4; p = 0.13). No differences in quality of life, anxiety and depression, advance care planning engagement, and in proportion of participants with advance directives were found between groups.CONCLUSIONS:The intervention showed no relevant effects on patient activation or quality of life in community dwelling older persons, possibly indicating the need for more tailored interventions. However, results are limited by a lack of statistical power.TRIAL REGISTRATION:German Clinical Trials Register: DRKS00016886.

INTRODUCTION:Physical restraints (PR) are regularly used in acute care settings, although evidence for their effectiveness and safety (eg, for prevention of falls) is lacking. Their use is associated with adverse events, such as decreased mobility and injuries for patients. We developed a complex intervention to prevent PR in acute care settings according to the UK Medical Research Council Framework, and investigated the feasibility. The intervention comprised the qualification of key nurses as multipliers and a short interprofessional information session. The intervention has proven to be feasible. It also became apparent that further development of the intervention and the study procedures is necessary. Therefore, this study aims to refine and pilot the complex intervention. Furthermore, the objective of this pilot study is to improve study procedures. METHODS AND ANALYSIS:In a preparatory phase, we will conduct focus groups and individual interviews with the target groups to explore the possibilities for adaption of the intervention and implementation strategies. Subsequently, a cluster-randomised controlled trial with a 6-month follow-up period will be conducted. It is planned to recruit eight general hospitals in Germany (area of Halle (Saale) and Leipzig) with 28 wards and 924 patients per observation period (2772 overall). Primary outcome is the proportion of patients with at least one PR after 6 months. Data will be collected by direct observation over a period of seven consecutive days and three times a day. Secondary outcomes are falls, interruptions in therapy and prescription of psychotropic medication. A comprehensive process evaluation will accompany the study. ETHICS AND DISSEMINATION:The Ethics committee of the Medical Faculty of the University of Halle (Saale) approved the study protocol. Results will be published in a peer-reviewed journal and presented at conferences. Study information and additional material will be freely available on an already existing website. TRIAL REGISTRATION NUMBER:DRKS00027989.

EDITORIAL article Front. Endocrinol., 12 September 2022Sec. Clinical Diabetes https://doi.org/10.3389/fendo.2022.1009564

Gestational diabetes (GDM) in the short term is associated with various complications during pregnancy; however, in the long run, women have an increased risk of type 2 diabetes mellitus (T2DM). Therefore, short‐ and long‐term follow‐up postpartum is recommended.

Zusammenfassung Bei Menschen mit chronischen Erkrankungen können häufige negative Gedanken einerseits mit ungünstigen Gesundheitsoutcomes, andererseits mit positiven Outcomes wie gesundheitsförderndem Verhalten in Verbindung stehen. Wir berichten die Ergebnisse einer Studie, die sich mit Gedanken an Gesundheit bei Menschen mit Diabetes befasst. Wir untersuchten Häufigkeit, Valenz und Zusammenhang solcher Gedanken mit gesundheitsbezogener Lebensqualität, diabetesbezogenen Belastungen und depressiven Symptomen.

Background: Many people with diabetes have permanently elevated blood sugar concentrations and a high level of diabetes-related psychological stress. also called "diabetes distress." In clinical practice, diabetes distress is often an impediment to successful self-management. psy-PAD is a psychodynamically oriented short-term therapy program whose goal is to reduce diabetes distress and improve glycemic control. Methods: A randomized controlled trial was conducted with 143 patients with either type 1 or type 2 diabetes who were being treated in eleven specialized diabetological practices. psy-PAD in the intervention group (eight sessions) was compared with optimized standard care as the control condition. The inclusion criteria were HbA1c >= 7.5% combined with diabetes distress (PAID >35, or doctor's determination). The primary endpoint was the HbA1c at six months (t(1)). Diabetes-related distress (PAID), depressive symptoms (HADS-D, PHQ-9), anxiety symptoms (HADS-A), health-related quality of life (SF-36), panic (short form of the PHQ-D), body mass index (BMI), and triglyceride levels were secondary endpoints. Follow-ups were conducted at six (t(1)) and 12 months (t(2)) (trial registration: DRKS00003247). Results: The intergroup comparison at t 1 revealed a significant, clinically relevant reduction of HbA1c by -0.53 percentage points (95% confidence interval [-0.89; -0.16], p = 0.005). The secondary analyses revealed relevant differences in the point estimators for diabetes distress at t(1) and t(2), depressive symptoms at t(2) and BMI at t(1). Conclusion: For people with diabetes and diabetes distress who do not achieve satisfactory glycemic control despite intensive treatment in specialized diabetological practices. integrated psychosomatic-psychotherapeutic treatment can lower blood sugar levels over the intermediate term and also reduce diabetes distress and depressive symptoms over a one-year period.

Aim: To determine the 10-year cumulative incidence of high depressive symptoms in people with diagnosed and, in particular, previously undetected diabetes compared to those without diabetes in a population-based cohort study in Germany. Materials and Methods: We included 2813 participants (52.9% men, mean age (SD) 58.9 (7.7) years, 7.1% diagnosed diabetes, 5.6% previously undetected diabetes) from the Heinz Nixdorf Recall study. We calculated the odds ratios (OR) with 95% confidence intervals (CI) using multiple logistic regression analyses for diagnosed and undetected diabetes. Results: Cumulative 10-year incidences (95%-CI) of high depressive symptoms in participants with diagnosed diabetes, previously undetected diabetes, and without diabetes were 15.4% (10.7-21.2), 10.1% (5.9-15.9), and 12.4% (11.1-13.8), respectively. Age-sex-adjusted ORs were 1.51 (1.01-2.28) in participants with diagnosed diabetes compared to those without, 1.40 (0.92-2.12) after adjustment for BMI, physical activity, education, and smoking, and 1.33 (0.87-2.02) after further adjustment for stroke and myocardial infarction. ORs in participants with previously undetected diabetes were 0.96 (0.56-1.65), 0.85 (0.49-1.47), and 0.85 (0.49-1.48), respectively, and lower in men than in women. Conclusion: As expected, we found an increased odds of developing high depressive symptoms in participants with diagnosed diabetes. However, the odds ratios decreased when we considered comorbidities and other covariates. Interestingly, in participants with previously undetected diabetes, the odds was not increased, even 10 years after detection of diabetes. These results support the hypothesis that high depressive symptoms develop due to diabetes-related burdens and comorbidities and not due to hyperglycemia or hyperinsulinemia.

Abstract Background: Families with minor children affected by parental cancer are at risk of considerable emotional and organizational stress that can severely burden all family members. So far, there has been a lack of comprehensive support services for affected families. The aim of this project is to implement and evaluate a complex psychosocial intervention for these families by providing advice, information and care on an emotional, psycho-social and communicative level during and after the cancer experience and across healthcare sectors.Methods: Family-SCOUT is a project supported by the German Innovation Fund (https://innovationsfonds.g-ba.de/). The evaluation is based on a mixed method quasi-experimental design with intervention and control group. A standardized postal survey at three measurement points (T0: study enrollment; T1: 3 months follow-up; T2: 9 months follow-up), secondary data from the participating health insurance funds, and semi-structured qualitative interviews are used for summative and formative evaluation. Study aim is to include n=560 families. Data will be analyzed according to the intention-to-treat principle. The primary analysis is the comparison of the Hospital Anxiety and Depression Scale (HADS) response rates (minimal important difference (MID) ≥ 1.6 in at least one of the two parents) at T2 between the intervention and control group using Fisher’s exact test. The conduct of the study as well as the development and implementation of the intervention will be accompanied by comprehensive study monitoring following the principles of an effectiveness-implementation hybrid study. Discussion: Results will allow to test the effectiveness and efficiency of the intervention for the target group. First experience with the implementation of the intervention in model regions will be available. The evaluation results will serve as basis to assess the need of including the intervention in the catalogue of services of the statutory health insurance funds in Germany. Trial registration: ClinicalTrials.gov, NCT04186923. Retrospectively registered on 4 December 2019.