Feasibility, safety and effectiveness of prednisolone and vitamin B1, B6, and B12 in patients with post-COVID-19-syndrome (PreVitaCOV) - protocol of a randomised, double-blind, placebo-controlled multicentre trial in primary care (phase IIIb).

BACKGROUND: After infection with SARS-CoV-2 a relevant proportion of patients complains about persisting symptoms, a condition termed Post-COVID-19-syndrome (PC19S). So far, possible treatments are under investigation. Among others, neurotropic vitamins and anti-inflammatory substances are potential options. Thus, the PreVitaCOV trial aims to assess feasibility, safety, and effectiveness of treating patients in primary care with prednisolone and/or vitamin B1, B6 and B12. METHODS: The phase IIIb, multi-centre randomised, double-blind, and placebo-controlled PreVitaCOV trial has a factorial design and is planned as a two-phase approach. The pilot phase assessed feasibility and safety and was transformed into a confirmatory phase to evaluate effectiveness since feasibility was proven. Adult patients with PC19S after a documented SARS-CoV-2 infection at least 12 weeks ago are randomly assigned to 4 parallel treatments: prednisolone 20 mg for five days followed by 5 mg for 23 days (trial drug 1), B vitamins (B1 (100 mg OD), B6 (50 mg OD), and B12 (500 µg OD)) for 28 days (trial drug 2), trial drugs 1 and 2, or placebo. The primary outcome of the pilot phase was defined as the retention rate of the first 100 patients. Values of ≥ 85% were considered as confirmation of feasibility, this criterion was even surpassed by a retention rate of 98%. After transformation, the confirmatory phase proceeds by enrolling 240 additional patients. The primary outcome for the study is the change of symptom severity from baseline to day 28 as assessed by a tailored Patient Reported Outcomes Measurement Information System (PROMIS) total score referring to five symptom domains known to be typical for PC19S (fatigue, dyspnoea, cognition, anxiety, depression). The confirmatory trial is considered positive if superiority of any treatment is demonstrated over placebo operationalised by an improvement of at least 3 points on the PROMIS total score (t-score). DISCUSSION: The PreVitaCOV trial may contribute to the understanding of therapeutic approaches in PC19S in a primary care context. TRIAL REGISTRATION: EudraCT: 2022-001041-20. DRKS: DRKS00029617. CLINICALTRIALS: gov: F001AM02222_1 (registered: 05 Dec 2022).

Quality of life in a high-risk group of elderly primary care patients: characteristics and potential for improvement.

PURPOSE: Quality of Life (QoL) is associated with a bandwidth of lifestyle factors that can be subdivided into fixed and potentially modifiable ones. We know too little about the role of potentially modifiable factors in comparison to fixed ones. This study examines four aspects of QoL and its associations with 15 factors in a sample of elderly primary care patients with a high risk of dementia. The main objectives are (a) to determine the role of the factors in this particular group and (b) to assess the proportion of fixed and potentially modifiable factors. METHOD: A high-risk group of 1030 primary care patients aged between 60 and 77 years (52.1% females) were enrolled in "AgeWell.de," a cluster-randomized, controlled trial. This paper refers to the baseline data. The multi-component intervention targets to decrease the risk of dementia by optimization of associated lifestyle factors. 8 fixed and 7 modifiable factors potentially influencing QoL served as predictors in multiple linear regressions. RESULTS: The highest proportion of explained variance was found in psychological health and age-specific QoL. In comparison to health-related QoL and physical health, the modifiable predictors played a major role (corr. R2: 0.35/0.33 vs. 0.18), suggesting that they hold a greater potential for improving QoL. CONCLUSION: Social engagement, body weight, instrumental activities of daily living, and self-efficacy beliefs appeared as lifestyle factors eligible to be addressed in an intervention program for improving QoL. TRIAL REGISTRATION: German Clinical Trials Register, reference number: DRKS00013555. Date of registration: 07.12.2017.

Effects of a multidomain intervention against cognitive decline on dementia risk profiles - Results from the AgeWell.de trial.

INTRODUCTION: Dementia risk scores constitute promising surrogate outcomes for lifestyle interventions targeting cognitive function. We investigated whether dementia risk, assessed using the LIfestyle for BRAin health (LIBRA) index, was reduced by the AgeWell.de intervention. METHODS: Secondary analyses of the AgeWell trial, testing a multicomponent intervention (including optimization of nutrition, medication, and physical, social, and cognitive activity) in older adults with increased dementia risk. We analyzed data from n = 461 participants with complete information on risk/protective factors comprised by LIBRA at the 24-month follow-up. Intervention effects on LIBRA and LIBRA components were assessed using generalized linear models. RESULTS: The intervention reduced LIBRA scores, indicating decreased dementia risk at follow-up (b = -0.63, 95% confidence interval [CI]: -1.14, -0.12). Intervention effects were particularly due to improvements in diet (odds ratio [OR]: 1.60, 95% CI: 1.16, 2.22) and hypertension (OR: 1.61, 95% CI: 1.19, 2.18). DISCUSSION: The AgeWell.de intervention reduced dementia risk. However, several risk factors did not improve, possibly requiring more intensive interventions. HIGHLIGHTS: The AgeWell.de intervention reduced dementia risk according to LIfestyle for BRAin health (LIBRA) scores. Beneficial effects on LIBRA are mainly due to changes in diet and blood pressure. A pragmatic lifestyle intervention is apt to reduce dementia risk in an at-risk population.

A multidomain intervention against cognitive decline in an at-risk-population in Germany: Results from the cluster-randomized AgeWell.de trial.

INTRODUCTION: We investigated the effectiveness of a multidomain intervention to preserve cognitive function in older adults at risk for dementia in Germany in a cluster-randomized trial. METHODS: Individuals with a Cardiovascular Risk Factors, Aging, and Dementia (CAIDE) risk score ≥ 9 aged 60 to 77 years were recruited. After randomization of their general practitioner (GP), patients received a multidomain intervention (including optimization of nutrition and medication, and physical, social, and cognitive activity) or general health advice and GP treatment as usual over 24 months. Primary outcome was global cognitive performance (composite z score, based on domain-specific neuropsychological tests). RESULTS: Of 1030 participants at baseline, n = 819 completed the 24-month follow-up assessment. No differences regarding global cognitive performance (average marginal effect = 0.010, 95% confidence interval: -0.113, 0.133) were found between groups at follow-up. Perceived restrictions in intervention conduct by the COVID-19 pandemic did not impact intervention effectiveness. DISCUSSION: The intervention did not improve global cognitive performance. HIGHLIGHTS: Overall, no intervention effects on global cognitive performance were detected. The multidomain intervention improved health-related quality of life in the total sample. In women, the multidomain intervention reduced depressive symptoms. The intervention was completed during the COVID-19 pandemic.

Social isolation in the oldest-old: determinants and the differential role of family and friends.

PURPOSE: To examine the association of sociodemographic and health-related determinants with social isolation in relation to family and friends in the oldest-old. METHODS: Database was the multi-center prospective AgeCoDe/AgeQualiDe cohort study assessed at follow-up wave 5 (N = 1148; mean age 86.6 years (SD 3.0); 67% female). Social isolation was assessed using the short form of the Lubben Social Network Scale (LSNS-6). The LSNS-6 contains two sets of items establishing psychometrically separable subscales for isolation from family and friends (ranges 0-15 points), with lower scores indicating higher isolation. Cross-sectional linear (OLS) regression analyses were used to examine multivariate associations of sociodemographic and health-related determinants with social isolation from family and friends. RESULTS: Overall, n = 395 participants (34.6%) were considered socially isolated. On average, isolation was higher from friends (mean 6.0, SD 3.8) than from family (mean 8.0, SD 3.5). Regression results revealed that in relation to family, males were more socially isolated than females (ß = - 0.68, 95% CI - 1.08, - 0.28). Concerning friends, increased age led to more isolation (ß = - 0.12, 95% CI - 0.19, - 0.05) and functional activities of daily living to less isolation (ß = 0.36, 95% CI 0.09, 0.64). Independent of the social context, depression severity was associated with more social isolation, whereas cognitive functioning was associated with less social isolation. CONCLUSIONS: Different determinants unequally affect social isolation in relation to family and friends. The context of the social network should be incorporated more strongly regarding the detection and prevention of social isolation to sustain mental and physical health.

Disentangling the relationship of subjective cognitive decline and depressive symptoms in the development of cognitive decline and dementia.

INTRODUCTION: Subjective cognitive decline (SCD) and depressive symptoms (DS) frequently co-occur prior to dementia. However, the temporal sequence of their emergence and their combined prognostic value for cognitive decline and dementia is unclear. METHODS: Temporal relationships of SCD, DS and memory decline were examined by latent difference score modeling in a high-aged, population-based cohort (N = 3217) and validated using Cox-regression of dementia-conversion. In 334 cognitively unimpaired SCD-patients from memory-clinics, we examined the association of DS with cognitive decline and with cerebrospinal fluid (CSF) Alzheimer's disease (AD) biomarkers. RESULTS: In the population-based cohort, SCD preceded DS. High DS were associated with increased risk of dementia conversion in individuals with SCD. In SCD-patients from memory-clinics, high DS were associated with greater cognitive decline. CSF Aß42 predicted increasing DS. DISCUSSION: SCD typically precedes DS in the evolution to dementia. SCD-patients from memory-clinics with DS may constitute a high-risk group for cognitive decline. HIGHLIGHTS: Subjective cognitive decline (SCD) precedes depressive symptoms (DS) as memory declines. Emerging or persistent DS after SCD reports predict dementia. In SCD patients, more amyloid pathology relates to increasing DS. SCD patients with DS are at high risk for symptomatic progression.

[General Practitioners' Experiences with COVID-19: a Survey After the First Wave of the Pandemic in March/April 2020]. / Erfahrungen von HausärztInnen mit COVID-19 und der Pandemie ­ ein Survey nach der ersten Pandemiewelle im März/April 2020.

BACKGROUND AND OBJECTIVES: The first wave of the COVID-19 pandemic (Mar-Apr 2020) posed significant challenges for primary care. The goal of this study was to analyse the burden of the crisis situation as experienced by the general practitioners (GPs) at its beginning and over the course of the pandemic and to identify factors predictive of the sense of being overburdened. METHODS: In this cross-sectional study, a total of 6300 randomly selected GPs in four federal states of Germany were contacted per post in order to survey changes in health care they provided and their psychological burden in the context of the pandemic between August and October 2020. RESULTS: The response rate was 23%; 46% of the participants were female. At the beginning of the pandemic, 40% of the participants experienced a high or a very high level of being overburdened; later on, it was only 10%. With increasing numbers of COVID patients, the sense of being overburdened increased, as also their perceived capability to care for COVID patients. Predictors of a sense of being overburdened were, among others, a high level of psychological stress, excessive organising efforts, poor capability to care for COVID patients, and scarce supply of protective equipment. CONCLUSION: Despite a sense of being overburdened initially, GPs felt increasingly capable of caring for COVID patients. To help GPs in future crisis situations like this pandemic, organization of care should be simplified to the extent possible so that they can focus on patient care.

Social support and health-related quality of life among the oldest old - longitudinal evidence from the multicenter prospective AgeCoDe-AgeQualiDe study.

PURPOSE: The aim of this study was to examine the longitudinal within-association between social support and health-related quality of life among the oldest old. METHODS: Longitudinal data (follow-up waves 7 to 9) were used from the multicenter prospective cohort study "Needs, health service use, costs and health-related quality of life in a large sample of oldest-old primary care patients (85 +)" (AgeQualiDe). n = 648 individuals were included in the analytical sample. At FU wave 7, mean age was 88.8 years (SD: 2.9 years, from 85 to 99 years). Social support was quantified using the Lubben Social Network Scale (6-item version). Health-related quality of life was assessed using the EQ-5D-3L including problems in five health dimensions, and its visual analogue scale (EQ VAS). It was adjusted for several covariates in conditional logistic and linear fixed effects regressions. RESULTS: Intraindividual decreases in social support were associated with an increased likelihood of developing problems in 'self-care', 'usual activities', 'pain/discomfort' and 'anxiety/depression' (within individuals over time). In contrast, intraindividual changes in social support were not associated with intraindividual changes in the EQ VAS score. CONCLUSION: Findings indicate a longitudinal intraindividual association between social support and problems, but only in some health dimensions. Further research in this area based on longitudinal studies among the oldest old (from different countries) is required.

Suspension of face-to-face teaching and ad hoc transition to digital learning under Covid-19 conditions - a qualitative study among dental students and lecturers.

BACKGROUND: In mid-March 2020, the coronavirus pandemic led to a national lockdown in Germany. Face-to-face teaching was cancelled in universities for the 2020 summer semester. Teaching moved online with no prior IT testing and lecturer training. The study analyses experiences of the suspension of face-to-face teaching and the move to digitalised learning for students and lecturers of dentistry at Kiel. METHODS: In summer 2020, qualitative guided interviews were conducted with students (4th, 6th, 8th, and 10th semesters), and lecturers. Deductive and inductive qualitative content analysis of the results was carried out. RESULTS: Thirty-nine students (69% female) and 19 lecturers (32% female) were interviewed. Reactions to the changes in teaching were observed. Feelings ranged from an essentially positive attitude, through insecurity and uncertainty to a failure to fully appreciate the situation. The loss of social contact was lamented. Digitalisation was associated with technological challenges and additional work. However, it also fostered learning independent of time and place, and encouraged autonomy. Negative aspects of digitalisation included a lack of feedback and loss of interaction. CONCLUSION: The introduction of ad hoc digitalisation challenged both students and lecturers alike. Dealing with lockdown and the changes in teaching and studying required significant flexibility.

Frailty and Autonomy among the Oldest Old: Evidence from the Multicenter Prospective AgeCoDe-AgeQualiDe Study.

INTRODUCTION: There is a lack of studies examining the link between perceived autonomy and frailty among the oldest old. Therefore, our objective was to fill this gap. METHODS: Data were used from the multicenter prospective cohort study "Needs, health service use, costs and health-related quality of life in a large sample of oldest-old primary care patients (85+)" (AgeQualiDe; follow-up [FU] wave 9; n = 510 observations in the analytical sample). The average age was 90.3 years (SD: 2.7 years). The Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale (CFS) was used to assess frailty. Socioeconomic and health-related covariates were included in our regression model. The autonomy scale developed by Schwarzer was used to assess perceived autonomy in old age. RESULTS: Adjusting for various confounders, multiple linear regressions showed that lower perceived autonomy was associated with increased levels of frailty (total sample: ß = -0.13, p < 0.001; women: ß = -0.14, p < 0.001; and men: ß = -0.12, p < 0.001). Furthermore, lower perceived autonomy was associated with more depressive symptoms, higher cognitive impairment, and being institutionalized (except for men) in the total sample and in both sexes, but it was not significantly associated with age, sex, marital status, educational level, and social support. CONCLUSION: Findings indicate that frailty is associated with lower autonomy among the oldest old. More generally, while health-related factors were consistently associated with autonomy, sociodemographic factors (except for being institutionalized) were not associated with autonomy among the oldest old. We should be aware of the strong association between autonomy and physical as well as mental health in very old age.

Association of mental demands in the workplace with cognitive function in older adults at increased risk for dementia.

OBJECTIVES: Growing evidence suggests a protective effect of high mental demands at work on cognitive function in later life. However, evidence on corresponding associations in older adults at increased risk for dementia is currently lacking. This study investigates the association between mental demands at work and cognitive functioning in the population of the AgeWell.de-trial. METHODS: Cross-sectional investigation of the association between global cognitive functioning (Montreal Cognitive Assessment) and mental demands at work in older individuals at increased risk for dementia (Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE)score ≥ 9; n = 941, age: 60-77 years). Occupational information was matched to Occupational Information Network (O*NET)-descriptors. Associations between cognitive function and O*NET-indices executive, verbal and novelty were investigated using generalized linear models. RESULTS: Higher values of index verbal (b = .69, p = .002) were associated with better cognitive function when adjusting for covariates. No association was observed for indices executive (b = .37, p = .062) and novelty (b = .45, p = .119). Higher education, younger age, and employment were linked to better cognitive function, while preexisting medical conditions did not change the associations. Higher levels of depressive symptomatology were associated with worse cognitive function. CONCLUSIONS: Higher levels of verbal demands at work were associated with better cognitive function for older adults with increased dementia risk. This suggests an advantage for older persons in jobs with high mental demands even after retirement and despite prevalent risk factors. Longitudinal studies are warranted to confirm these results and evaluate the potential of workplaces to prevent cognitive decline through increased mental demands.

Mild cognitive impairment and quality of life in the oldest old: a closer look.

PURPOSE: Mild cognitive impairment (MCI) is a widespread phenomenon, especially affecting older individuals. We will analyze in how far MCI affects different facets of quality of life (QOL). METHODS: We used a sample of 903 participants (110 with MCI) from the fifth follow-up of the German Study on Ageing, Cognition, and Dementia in Primary Care Patients (AgeCoDe), a prospective longitudinal study, to analyze the effects of MCI on different facets of the WHOQOL-OLD. We controlled for age, gender, marital status, education, living situation, daily living skills, and the ability to walk, see, and hear. RESULTS: Univariate analyses showed that individuals with MCI exhibited lower QOL with regard to the facets autonomy; past, present, and future activities; social participation; and intimacy, but less fears related to death and dying. No significant difference was shown with regard to the facet sensory abilities. In multivariate analyses controlling for age, gender, marital status, education, living situation, daily living skills, and the ability to walk, see and hear, MCI-status was significantly associated with QOL in the facet autonomy. CONCLUSION: Effects of MCI go beyond cognition and significantly impact the lives of those affected. Further research and practice will benefit from utilizing specific facets of QOL rather than a total score.

EQ-5D-3L health status and health state utilities of the oldest-old (85 +) in Germany: results from the AgeCoDe-AgeQualiDe study.

PURPOSE: To describe health status and health state utilities measured by the EQ-5D-3L in a population-based sample of individuals aged 85 + in Germany, and to analyze associations with basic socio-demographic variables. METHODS: Cross-sectional data from follow-up wave 7 (n = 761) of the German AgeCoDe Study were used. The EQ-5D-3L questionnaire was used to record problems in five health dimensions, its visual analogue scale (EQ VAS) was used to record self-rated health status, and the German EQ-5D-3L index was used to derive health state utilities. RESULTS: Mean age of respondents was 88.9 years (SD 2.9; range 85 to 100), 67.4% were female. 81.9% reported problems in at least one of the EQ-5D dimensions, with 15.3% reporting extreme problems. Most frequent were problems with pain/discomfort (64.8%), followed by mobility (62.5%), usual activities (42.6%), self-care (28.2%), and anxiety/depression (20.5%). Mean EQ VAS score was 62.4 (SD 18.8), and mean EQ-5D index was 0.77 (SD 0.24). Multiple regression analysis showed associations of problem frequency in various EQ-5D dimensions with age, gender, living situation, marital status, and education. The EQ VAS score was negatively associated with age (ß = - 0.56; p < 0.05) and female gender (ß = - 3.49; p < 0.05). The EQ-5D index was negatively associated with not living in the community (ß = - 0.10; p < 0.001) and being single (ß = - 0.09; p < 0.05). CONCLUSIONS: The results show a substantially impaired health status of the oldest-old population. The data can be used for comparing health status of population groups as well as for health economic models.

Correlates of hospitalization among the oldest old: results of the AgeCoDe-AgeQualiDe prospective cohort study.

BACKGROUND: Hospitalization is a key driver of health care costs. Thus far, there are only a few longitudinal studies investigating whether changes in explanatory variables lead to hospitalization. Moreover, these longitudinal studies did not focus on individuals in highest age. AIM: The purpose of the current study was to examine the correlates of hospitalization among the oldest old in Germany longitudinally. METHODS: A multicenter prospective cohort study ["Study on Needs, health service use, costs and health-related quality of life in a large sample of oldest-old primary care patients (85+)", AgeQualiDe]. Primary care patients ≥ 85 years took part [n = 861 at follow-up (FU) 7, average age of 89.0 years; 85-100 years]. Two waves were used. Hospitalization in the last 6 months was used as outcome measure. Well-established scales were used to quantify the independent variables such as Instrumental Activities of Daily Living Scale, Global Deterioration Scale or Geriatric Depression Scale. RESULTS: Logistic random effects regressions showed that the probability of hospitalization in the preceding 6 months significantly increased with increases in the social network, more depressive symptoms, functional decline, and increase in chronic conditions, whereas it was not significantly associated with age, sex, marital status, education, and cognitive impairment. Social networks moderate the relationship between functional decline and hospitalization. DISCUSSION: The results of the present longitudinal study emphasize the association of depressive symptoms, functional decline, more social networks, and chronic conditions with hospitalization among the oldest old. CONCLUSIONS: Treatments with the aim to reduce or postpone these factors might also help to reduce hospitalization.

Needs and health care costs in old age: a longitudinal perspective: results from the AgeMooDe study.

Background: The current study aimed to identify whether needs are associated with health care costs in late life longitudinally.Methods: Data were gathered from two waves (at baseline, n = 1199; at follow-up, n = 958) of a multicenter prospective cohort study ('Late-life depression in primary care: needs, health care utilization and costs', AgeMooDe) in Germany. Individuals aged 75 years and above were recruited via general practitioners. The 'Camberwell Assessment of Need for the Elderly' (CANE) was used to assess needs. Based on a questionnaire, the health-related resource use was assessed retrospectively from a societal perspective. The assessment covered outpatient services, inpatient treatment, pharmaceuticals, as well as formal and informal nursing care. Random effects regressions were used.Results: Regressions showed that the number of 'no needs' is inversely associated with total health care costs from a societal perspective (ß = -584.0, p < .001). When a health care perspective was adopted, this association was also significant (ß = -298.8, p < .001). The association between needs and health care costs persisted in all health care sectors considered in this study.Limitations: It might be difficult to generalize our findings to individuals residing in institutional settings.Conclusion: Adjusting for several potential confounders (e.g. sociodemographic and health-related factors), our study showed that needs - quantified using the CANE - are important for health care costs. Interventions should be developed to reduce needs in late life. These interventions may be beneficial for the health care system.

Prediction of dementia of Alzheimer type by different types of subjective cognitive decline.

INTRODUCTION: Subjective cognitive decline (SCD) is a risk condition for dementia, including dementia of Alzheimer type (DAT). METHODS: We report sensitivity, specificity, positive and negative predictive values (PPV, NPV) for conversion to all-cause dementia, and DAT in different SCD types (decline in memory, assocated worries, longitudinal consitency, of the AgeCoDe study (n = 2.402, 12 years follow-up). RESULTS: 82.7% of those converting to any dementia and 84.4% of those converting with DAT at follow-up, reported memory decline and fulfilled criteria of SCD at least at one time point before. SCD with worries at two consecutive time points showed a specificity of 92.2% for any dementia and also for DAT as well as a PPV of 44.3% for any dementia and of 36.9% for DAT at follow-up at the expense of low sensitivity. DISCUSSION: Different SCD subtypes were either sensitive or specific for future all-cause dementia and DAT in cognitively unimpaired individuals. Modest PPV of the most specific SCD subtypes were achieved in this low prevalence population.

Is function in instrumental activities of daily living a useful feature in predicting Alzheimer's disease dementia in subjective cognitive decline?

OBJECTIVE: Subjective cognitive decline (SCD), the earliest symptom in preclinical Alzheimer's disease (AD), is insufficient to identify individuals at risk for AD dementia. Therefore, we aimed to investigate whether function in instrumental activities of daily living (IADL) contributes to identification. METHODS: We analysed data of cognitively unimpaired participants of the prospective German Study on Ageing, Cognition, and Dementia in Primary Care Patients (AgeCoDe) and its extension, the Study on Needs, Health Service Use, Costs and Health-related Quality of Life in a Large Sample of Oldest-old Primary Care Patients (AgeQualiDe), collected over 10.5 years. Development of AD dementia was quantified as incidence rates (IRs) per 1000 person-years. Cox regression was used to assess the association of SCD and IADL function in regard to incident AD dementia. RESULTS: Of 1467 included individuals, 792 (54.0%) reported SCD at baseline. Impaired IADL were present in 50 (3.4%) individuals. IR for AD dementia was highest in individuals with SCD and impaired IADL (49.7; 95% CI, 24.8-99.3). Unadjusted and adjusted Cox analyses revealed an increased AD dementia risk for individuals with SCD and impaired IADL (uHR = 6.1; 95% CI, 2.9-13.0; P < 0.001; aHR = 2.5; 95% CI, 1.1-5.7; P < 0.05). CONCLUSIONS: Consistent with the SCD concept, IADL function was largely well preserved in the majority of individuals with SCD. However, if difficulties in IADL were present, risk for AD dementia was increased. Therefore, screening for IADL impairment could serve as an economically viable indicator to assess AD dementia risk above and beyond SCD.

AgeWell.de - study protocol of a pragmatic multi-center cluster-randomized controlled prevention trial against cognitive decline in older primary care patients.

BACKGROUND: In the absence of treatment options, the WHO emphasizes the identification of effective prevention strategies as a key element to counteract the dementia epidemic. Regarding the complex nature of dementia, trials simultaneously targeting multiple risk factors should be particularly effective for prevention. So far, however, only few such multi-component trials have been launched, but yielding promising results. In Germany, comparable initiatives are lacking, and translation of these complex interventions into routine care was not yet done. Therefore, AgeWell.de will be conducted as the first multi-component prevention trial in Germany which is closely linked to the primary care setting. METHODS: AgeWell.de will be designed as a multi-centric, cluster-randomized controlled multi-component prevention trial. Participants will be older community-dwelling general practitioner (GP) patients (60-77 years; n = 1,152) with increased dementia risk according to CAIDE (Cardiovascular Risk Factors, Aging, and Incidence of Dementia) Dementia Risk Score. Recruitment will take place at 5 study sites across Germany. GP practices will be randomized to either intervention A (advanced) or B (basic). GPs will be blinded to their respective group assignment, as will be the statistician conducting the randomization. The multi-component intervention (A) includes nutritional counseling, physical activity, cognitive training, optimization of medication, management of vascular risk factors, social activity, and, if necessary, further specific interventions targeting grief and depression. Intervention B includes general health advice on the intervention components and GP treatment as usual. We hypothesize that over the 2-year follow-up period the intervention group A will benefit significantly from the intervention program in terms of preserved cognitive function/delayed cognitive decline (primary outcome), and other relevant (secondary) outcomes (e.g. quality of life, social activities, depressive symptomatology, cost-effectiveness). DISCUSSION: AgeWell.de will be the first multi-component trial targeting risk of cognitive decline in older adults in Germany. Compared to previous trials, AgeWell.de covers an even broader set of interventions suggested to be beneficial for the intended outcomes. The findings will add substantial knowledge on modifiable lifestyle factors to prevent or delay cognitive decline. TRIAL REGISTRATION: German Clinical Trials Register (reference number: DRKS00013555 ).

A qualitative study on older primary care patients' perspectives on depression and its treatments - potential barriers to and opportunities for managing depression.

BACKGROUND: Depression is one of the most common mental disorders in old age and is associated with various negative health consequences for the affected individual. Studies suggest that patients' views on depression have an impact on help-seeking behaviour and treatment. It is thus important to investigate the patient's perspective in order to ascertain optimum management of depression in late life. However, studies on depression and its treatment exploring the perspectives of primary care patients 75 years or older, are rare. METHODS: Qualitative data was collected in semi-structured interviews with 12 primary care patients 75 years of age or older with symptoms of depression. Data was analysed using qualitative content analysis. RESULTS: The study's results show the multifaceted views on and treatment of depression in primary care patients 75 years of age or older. Some patients seemed well informed about depression and believed in the efficacy of different treatments, such as medications or psychotherapy. However, some individuals had misconceptions about depression and its treatments. Patients mentioned that they would rather avoid talking about depression within their social network, in part of fear of negative reactions. Furthermore, participants believed that other people had little understanding for people with depression. Patients had different views on the relevance of the general practitioner's (GP) role in treating depression; some patients believed that the GP had little importance in the treatment of depression. CONCLUSIONS: This study identified positive views of primary care patients 75 years of age or older towards depression as well as views that might hinder optimal treatments. Exemplary implications for an improved management of depression are: educating older adults about depression via age-specific information and having professionals encourage patients in believing that depression is a recognised disorder.