Abstract People living with dementia (PlwD) have an increased risk of hospital admission which may result in severe consequences. The DemWG-study therefore aims to investigate whether a complex intervention in shared housing arrangements (SHA) for PlwD reduces the number of hospital admissions. Furthermore, quality of life, risk of falls, and stabilization of cognitive abilities are assessed. The intervention includes motor and cognitive training for PlwD and education of caregivers and general practitioners. The study is conducted in 88 SHA in Germany with a total of 330 PlwD and a 6 months intervention. Data are collected up to 18 months after baseline, including quantitative and qualitative data. Results from caregivers’ perspectives on the intervention designate a perceived improved social interaction, which in turn has a positive effect on living together in the SHA. Based also on the results of the ongoing quantitative assessments recommendations for better care and support will be derived.

Background Multimorbidity, polypharmacy, and potentially inappropriate medication (PIM) pose challenges for the care of people with cognitive impairment. The aim of the present study is to explore whether multimorbidity, polypharmacy, and PIM predict falls and hospital admissions in a sample of people with cognitive impairment in day-care centers in Germany. Methods We used data from the German day-care study (multicenter longitudinal study, n = 433). Multimorbidity was defined as ≥ 2 chronic diseases. Polypharmacy was defined as prescriptions to ≥ 5 drugs. Potentially inappropriate medication was defined as scoring on the PRISCUS list. Binary logistic regression analyses were computed to determine whether multimorbidity, polypharmacy, and potentially inappropriate medication at t0 predicted falls and hospital admissions as outcomes at t1 (six months later). Results The rate of multimorbidity and polypharmacy was 87.8% and 60.3%, respectively. 15.9% of the people with cognitive impairment received PIM / PRISCUS-listed drugs, 43.6% ACB-listed drugs, and 52.7% CNS depressant drugs. Falls and hospital admissions during follow-up were prevalent in 19.4% and 24.7% of the people with cognitive impairment. Both were significantly predicted by the total number of drugs (falls: OR = 1.152, p = 0.001, overall model: p < 0.001; hospital admissions: OR = 1.103, p = 0.020, overall model: p = 0.001), even if regression analyses were controlled for the number of comorbidities. Conclusions Polypharmacy and potentially inappropriate medication are highly prevalent in people with cognitive impairment in German day-care centers. The number of drugs and appropriateness of medication seem to be crucial for the risk of falls and hospital admissions. Polypharmacy and PIM should be critically reviewed by healthcare providers and avoided as much as and whenever possible. Trial registration ISRCTN16412551, 30 July 2014, registered partly retrospectively.

Background Most people with dementia wish to remain at home for as long as possible. Therefore, it is important to know the predictors of institutionalization, especially those that can be influenced. The aim of the present study is to identify predictors of the institutionalization of people with mild cognitive impairment (MCI) to moderate dementia who attend day care facilities (DCFs) throughout Germany. Methods This study is a secondary analysis of longitudinal data from 371 dyads comprising a cognitively impaired care receiver (CR) and a caregiver (CG). The data were collected in DCFs and via telephone interviews at three measurement points. To investigate the extent to which 16 variables could predict the institutionalization of the CRs between the 6- and 12-month follow-up, in the first step bivariate Cox regressions were calculated. In the second step, significant predictors were included in a model using multivariate Cox regression. Results Between the 6- and 12-month evaluations, 39 CRs moved into an institution. The risk of institutionalization of people with MCI to moderate dementia attending a DCF increased significantly ( p < .05) when the CRs showed more neuropsychiatric symptoms (Hazard ratio (HR) = 1.237), when the CRs and their CGs did not live together in the same house (HR = 2.560), or when the care level of the CRs is low (HR = 2.241). Conclusions Neuropsychiatric symptoms could be a possible starting point for therapeutic interventions that are designed to delay or prevent institutionalization. CG who do not live with their CR in the same house and CG who care for a CR with impairment in performing daily routine tasks care are particularly likely to make the decision to institutionalize the CR. For this group, advice and support are particularly important. Trail registration ISRCTN16412551 .

SummaryDie Versorgung von Menschen mit Demenzstellt Medizin und Wissenschaft vor einegroße Herausforderung. Da bis heute keinekurative Arzneimitteltherapie zur Verfügungsteht, kommt nichtpharmakologischen Präventions- und Therapiestrategien eine bedeutendeRolle zu. Ziel des Projekts „Opti-Dem“ – Optimierungsstrategien bei Demenz:Forschung zu Prävention, Therapieund Versorgung war es, das aktuelle Wissenüber Demenz in einer Forschungsplattformzu bündeln und zu bewerten und so die Vorbeugung, Behandlung und Versorgung vonMenschen mit Demenz zu verbessern.

Introduction Shared-housing arrangements (SHAs) are small, home-like care environments in Germany. Residents are predominantly people with dementia. The risk for all-cause hospitalisation is consistently higher for people with dementia compared with people without dementia and there is currently no evidence-based intervention to reduce the risk of hospitalisation. Thus, the DemWG study investigates whether a complex intervention is effective in reducing hospitalisation (primary outcome), behavioural and psychological symptoms of dementia and falls and for stabilising cognitive functioning and quality of life in people with dementia and mild cognitive impairment (MCI) in German SHAs. Methods and analysis Based on the UK Medical Research Council framework ‘Developing and evaluating complex interventions’, a prospective, mixed-methods, multicentre, cluster-randomised controlled trial combining primary and secondary data analyses as well as quantitative and qualitative research methods is being conducted. The intervention consists of three parts: (A) education of nursing staff in SHAs; (B) awareness raising and continuing medical education (CME) of general practitioners; (C) multicomponent non-pharmacological group intervention MAKS-mk+ (‘m’=motor training; ‘k’=cognitive training; ‘+’=fall prevention) for people with dementia and MCI. Randomisation is stratified by the German federal states and type of setting (rural vs urban). Neither the trained professionals nor the participants are blinded. Data are collected at baseline and after 6, 12 and 18 months with standardised instruments. Quantitative data will be analysed by multivariate analyses according to the general linear model, qualitative data using qualitative content analysis. Recruitment is still ongoing until 31 December 2020. Ethics and dissemination All procedures were approved by the Ethics Committee of the University of Bremen (Ref. 2019-18-06-3). Informed consent will be obtained before enrolment of participants. Due to findings of previous randomised controlled trials, serious adverse events are not expected. Results will be disseminated in peer-reviewed journal publications and conference presentations. Trial registration number ISRCTN89825211.

Background: Multicomponent non-pharmacological therapies have been shown to be effective at reducing cognitive symptoms and slowing deterioration in abilities to perform activities of daily living (ADL) in individuals with cognitive impairment. However, little is known about response rates and predictors of response. Methods: We used data from the German day-care study (DeTaMAKS; De = dementia, Ta = Tagespflege/day-care, M = motor stimulation, A = activities of daily living stimulation, K = k/cognitive stimulation, S = social stimulation; n = 362), which was based on a cluster-randomized trial of the non-pharmacological, multicomponent, anti-dementia MAKS therapy for people with cognitive impairment in day-care centers. We investigated response (defined as improvement or no deterioration) for three different response criteria: cognition via Mini-Mental State Examination (MMSE) score, ADL via Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM) score, and behavioral and psychological symptoms of dementia (BPSD) via Neuropsychiatric Inventory Questionnaire (NPI-Q) score. In addition, we calculated the number needed to treat (NTT) and response rates according to net gain analyses. Results: For all three criteria, the response rates were higher in the intervention group than in the control group (chi2 test: p = 0.058 to p = 0.003). Compared with non-responders, responders according to cognition had higher ETAM scores (= better ADL abilities) at baseline; responders according to ADL had lower ETAM scores (= poorer ADL abilities) at baseline; and responders according to BPSD had higher NPI-Q scores (= more BPSD) at baseline. Classification rates based on these predictors ranged from 60.6 to 68.3%. Discussion: The response rates to the non-pharmacological MAKS therapy were greater than those reported for anti-dementia drugs. There were only a few differences between responders and non-responders. Because of the low classification rates, these variables had only a small impact on response predictions. Therefore, there are no empirically substantiated selection criteria for the application of MAKS therapy in facilities. Clinical Trial Registration: www.ClinicalTrials.gov, identifier ISRCTN16412551.

Day-care and telephone counseling have been discussed as effective support measures for caregivers of people with cognitive impairment. In a two-arm cluster-randomized trial involving multicomponent therapy for cognitively impaired persons in day-care centers and telephone counseling for their caregivers versus treatment as usual (TAU), we investigated long-term effects on caregivers’ burden and depressiveness. Person-caregiver dyads involving home-dwelling persons with MCI, mild dementia, or moderate dementia were eligible. Day-care centers were randomized into an intervention group (IG) or a control group (CG). Outcome assessors were blinded. Out of 359 caregivers who had completed a 6-month intervention phase (nIG = 205, nCG = 154), a total of 304 of them were available at the 12-month follow-up (nIG = 173, nCG = 131). Instruments for assessing were the Burden Scale for Family Caregivers – short version (BSFC-s) (caregiver burden) and the Well-Being Index Score (WHO-5) (depressiveness). Mixed ANOVAs were used for the main analyses; descriptive statistics and subgroup analyses were additionally performed; secondary analyses involved multiple linear regressions for the main outcomes that were significant in the unadjusted main analysis. At follow-up, crude mean differences showed a nonsignificant advantage for the IG in caregiver burden [IG: −.20 (SD = 5.39) vs. CG: .76 (SD = 5.49), p = .126, d = .177] and depressiveness (reverse scored) [IG: −.05 (SD = 5.17) vs. CG: −.98 (SD = 5.65), p = .136, d = .173]. For caregiver burden, a mixed ANOVA resulted in significant main effects of group (F (1, 302) = 4.40; p = .037) and time (F (1.88, 568.96) = 3.56; p = .032) but not a significant interaction. The largest effects were found for the “mild dementia” subgroup (d = .443 for caregiver burden and d = .520 for depressiveness). Positive long-term effects of a combined intervention involving telephone counseling for caregivers and multicomponent activation for patients were observed especially for mild dementia. However, the treatment effects washed out after the intervention ended. ISRCTN16412551 (date: 30 July 2014, retrospectively).

Introduction: Though psychosocial well-being and quality of life generally improve after transplantation, a relevant proportion of patients suffers from psychosocial problems. Further analysis of the psychological coping after kidney transplantation is needed to identify patients at risk. The aim of this study was to examine the psychological response after kidney transplantation and its associations with health-related quality of life and immunosuppressant medication adherence. Materials and methods: The coping process after kidney transplantation was investigated with the Transplant Effects Questionnaire (TxEQ; subscales: worry, guilt, disclosure, adherence, responsibility) in 267 adult kidney transplant recipients ≥12 months post-transplantation. Furthermore, perceived health-related quality of life, self-reported immunosuppressant medication adherence, and sub-therapeutic immunosuppressant trough levels as biological markers of adherence were assessed. Results: Patients showed moderate scores concerning the subscales “worry”, “guilt”, and “responsibility” as well as high scores concerning “disclosure”. Except for “adherence”, all TxEQ subscales were associated with mental, but not with physical health-related quality of life and self-reported adherence. Sub-therapeutic immunosuppressant trough levels were significantly associated only with the TxEQ subscale “worry”. Conclusions: The present results suggest a conditional structure in which mental health-related quality of life is negatively associated with worries, guilt, and responsibility and positively with disclosure. Adherence seems to be a complex behavior, which is not necessarily directly associated with the psychological processing of organ transplantations. As mental health-related quality of life is related to this psychological processing, the TxEQ could be used as a screening tool for problematic psychological processing after kidney transplantation.

INTRODUCTION:Non-adherence to immunosuppressive medication is regarded as an important factor for graft rejection and loss after successful renal transplantation. Yet, results on prevalence and relationship with psychosocial parameters are heterogeneous. The main aim of this study was to investigate the association of immunosuppressive medication non-adherence and psychosocial factors. METHODS:In 330 adult renal transplant recipients (≥12 months posttransplantation), health-related quality of life, depression, anxiety, social support, and subjective medication experiences were assessed, and their associations with patient-reported non-adherence was evaluated. RESULTS:33.6% of the patients admitted to be partially non-adherent. Non-adherence was associated with younger age, poorer social support, lower mental, but higher physical health-related quality of life. There was no association with depression and anxiety. However, high proportions of clinically relevant depression and anxiety symptoms were apparent in both adherent and non-adherent patients. CONCLUSION:In the posttransplant follow-up, kidney recipients with lower perceived social support, lower mental and higher physical health-related quality of life, and younger age can be regarded as a risk group for immunosuppressive medication non-adherence. In follow-up contacts with kidney transplant patients, physicians may pay attention to these factors. Furthermore, psychosocial interventions to optimize immunosuppressive medication adherence can be designed on the basis of this information, especially including subjectively perceived physical health-related quality of life and fostering social support seems to be of importance.

Different measures of non-adherence to immunosuppressant (IS) medication have been found to be associated with rejection episodes after successful transplantation. The aim of the current study was to investigate whether graft rejection after renal transplantation is associated with patient-reported IS medication non-adherence and IS trough level variables (IS trough level variability and percentage of sub-therapeutic IS trough levels).

BACKGROUND:The Transplant Evaluation Rating Scale (TERS) was developed to provide a standardized evaluation of the psychosocial functioning of patients, before transplantation. Yet, the first 2 items of the TERS are based on psychiatric diagnoses referring to Diagnostic and Statistical Manual (DSM)-III-R, which leads to a duplication of disorder-specific and symptom-specific contents, that makes it complex to rate. Moreover, the TERS has not been updated to DSM revisions and DSM is not used for the official clinical routine documentation in several European countries. OBJECTIVE:The objective of this study was, therefore, to investigate the psychometric properties of a diagnoses-corrected version of the TERS (items 1 and 2 omitted). METHODS:In 85 patients awaiting liver transplantation, the discrimination capacities, predictive value, convergent validity, and interrater reliability of the original version (TERS10) and the diagnoses-corrected version (TERS8) were analyzed. RESULTS:In both versions, patients with psychiatric diagnoses (69.4%) exhibited significantly higher TERS mean values than patients without psychiatric disorders. This also held for patients who were temporarily not found eligible for transplantation in the psychosocial evaluation (25.9%) compared with patients who were eligible for listing for transplantation. Furthermore, the area under the curve was >0.90 for both versions and a cutoff of 32.25 is suggested for TERS8 (sensitivity of 90.9% and specificity of 87.3%). CONCLUSIONS:Our results substantiate good psychometric properties of the revised (diagnoses corrected) TERS, which is of great benefit for standardized psychosocial evaluation before liver transplantation. Further, validation of TERS8 and its cutoff in other samples of (liver) transplantation patients is needed.