Profiles of Met and Unmet Care Needs in the Oldest Old Primary Care Patients with Cognitive Disorders and Dementia: Results of the AgeCoDe and AgeQualiDe Study.

INTRODUCTION: The prevalence of mild cognitive impairment (MCI) and dementia is increasing as the oldest old population grows, requiring a nuanced understanding of their care needs. Few studies have examined need profiles of oldest old patients with MCI or dementia. Therefore, this study aimed to identify patients' need profiles. METHODS: The data analysis included cross-sectional baseline data from N = 716 primary care patients without cognitive impairment (n = 575), with MCI (n = 97), and with dementia (n = 44) aged 85+ years from the multicenter cohort AgeQualiDe study "needs, health service use, costs and health-related quality of life in a large sample of oldest old primary care patients [85+]". Patients' needs were assessed using the Camberwell Assessment of Needs for the Elderly (CANE), and latent class analysis identified need profiles. Multinomial logistic regression analyzed the association of MCI and dementia with need profiles, adjusting for sociodemographic factors, social network (Lubben Social Network Scale [LSNS-6]), and frailty (Canadian Study of Health and Aging-Clinical Frailty Scale [CSHA-CFS]). RESULTS: Results indicated three profiles: "no needs," "met physical and environmental needs," and "unmet physical and environmental needs." MCI was associated with the met and unmet physical and environmental needs profiles; dementia was associated with the unmet physical and environmental needs profile. Patients without MCI or dementia had larger social networks (LSNS-6). Frailty was associated with dementia. CONCLUSIONS: Integrated care should address the needs of the oldest old and support social networks for people with MCI or dementia. Assessing frailty can help clinicians to identify the most vulnerable patients and develop beneficial interventions for cognitive disorders.

The effect of depressive symptoms on quality of life and its different facets in the oldest age population: evidence from the AgeQualiDe prospective cohort study.

PURPOSE: The present study aims to investigate the prospective effect of depressive symptoms on overall QoL in the oldest age group, taking into account its different facets. METHODS: Data were derived from the multicenter prospective AgeCoDe/AgeQualiDe cohort study, including data from follow-up 7-9 and n = 580 individuals 85 years of age and older. Overall QoL and its facets were assessed using the WHOQOL-OLD instrument. The short form of the geriatric depression scale (GDS-15) was applied to assess depressive symptoms. Cognitively impaired individuals were excluded. Linear mixed-effects models were used to assess the effect of depressive symptoms on QoL. RESULTS: Depressive symptoms were significantly associated with overall QoL and each of the different facets of WHOQOL-OLD, also after adjustment for time and sociodemographic characteristics such as age, gender, education, marital status, living situation, and cognitive status. Higher age and single as well as divorced marital status were also associated with a lower QoL. CONCLUSION: This work provides comprehensive longitudinal results on the relationship between depressive symptoms and QoL in the oldest age population. The results underscore the relevance of tailored and targeted care planning and the development of customized interventions.

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.

Behind the times? Associations of working-time autonomy with health-related and occupational outcomes in health care personnel- a latent profile analysis.

BACKGROUND: In the light of personnel shortage, the health care sector is facing the challenge to combine increasing employees' as well as patients' needs. The aim of this study was to investigate the association between working-time autonomy and health-related (fatigue, psychosomatic complaints and work ability), as well as occupational outcomes (job satisfaction and turnover intention) in a large sample of health care employees. METHOD: Based on data of the BauA-Working Time survey, a sample of n = 1,093 employees working in the health care sector was analysed. Outcomes were assessed by the German Fatigue Scale, the Work Ability-Index and single-item measurements. Besides descriptive analyses, latent profile analysis (LPA) was used to determine clusters of employees based on working-time autonomy. Subsequently, regression analyses have been conducted to examine the association between autonomy clusters with health-related and occupational outcomes, controlling for sociodemographic characteristics and employment status. RESULTS: LPA revealed that a three-cluster model was most suitable: high autonomy (cluster 1), medium autonomy (cluster 2) and low autonomy (cluster 3). The extracted profiles of working-time autonomy differed significantly in terms of sociodemographic and occupational characteristics, but not in terms of average working hours per week or monthly household income. The multivariate regression analysis revealed that being in the low-autonomy cluster was associated with more psychosomatic health complaints (IRR: 1.427, p = 0.008), lower work ability (OR 0.339, p < 0.001), as well as less job satisfaction (OR 0.216, p < 0.001). DISCUSSION: Overall, the analyses indicate that it is crucial to prospectively consider working-time autonomy as an important factor of satisfaction, well-being and turnover intention in health care employees.

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.

Lifestyle and incident dementia: A COSMIC individual participant data meta­analysis.

INTRODUCTION: The LIfestyle for BRAin Health (LIBRA) index yields a dementia risk score based on modifiable lifestyle factors and is validated in Western samples. We investigated whether the association between LIBRA scores and incident dementia is moderated by geographical location or sociodemographic characteristics. METHODS: We combined data from 21 prospective cohorts across six continents (N = 31,680) and conducted cohort-specific Cox proportional hazard regression analyses in a two-step individual participant data meta-analysis. RESULTS: A one-standard-deviation increase in LIBRA score was associated with a 21% higher risk for dementia. The association was stronger for Asian cohorts compared to European cohorts, and for individuals aged ≤75 years (vs older), though only within the first 5 years of follow-up. No interactions with sex, education, or socioeconomic position were observed. DISCUSSION: Modifiable risk and protective factors appear relevant for dementia risk reduction across diverse geographical and sociodemographic groups. HIGHLIGHTS: A two-step individual participant data meta-analysis was conducted. This was done at a global scale using data from 21 ethno-regionally diverse cohorts. The association between a modifiable dementia risk score and dementia was examined. The association was modified by geographical region and age at baseline. Yet, modifiable dementia risk and protective factors appear relevant in all investigated groups and regions.

[Loneliness in unemployed individuals diagnosed with mental illness]. / Einsamkeit bei Arbeitslosen mit psychischen Erkrankungen.

BACKGROUND: Loneliness is a widespread phenomenon, and it is associated with a variety of health problems and diseases. Unemployed individuals diagnosed with a mental illness (UMIs) are at a high risk of experiencing loneliness, with serious repercussions for their health and vocational rehabilitation. With this study we wanted to better understand the associations between sociodemographic variables, mental health, and loneliness in UMIs. METHODS: We analyzed the data of 526 unemployed individuals that received means-tested benefits as well as at least one psychiatric diagnosis. Data were collected between September 2020 and September 2023. We conducted two robust regressions with loneliness (University of California, Los Angeles, Loneliness Scale, UCLA) as an outcome (N = 526). In the first regression, we used social network as a predictor (Lubben Social Network Scale, LSNS-6); in the second regression we included the additional predictors personal debt (yes/no), depression (Patient Health Questionnaire, PHQ-9), anxiety (Mini-Symptom-Checklist,MSCL), and somatization (MSCL) as well as age, gender, education, and living with a partner as control variables. RESULTS: We found a significant negative association between social network and loneliness, and a significant positive association between a high level of education, depression, anxiety, and loneliness. CONCLUSIONS: Unemployed individuals diagnosed with a mental illness in our sample exhibited high levels of depression, anxiety, somatization, and loneliness. The associations between social network, mental health, and loneliness that we found emphasize the importance of psychological screening and/or diagnostics, and they highlight areas for prevention.

[The relationship between obesity, social isolation, and mental health-results from the LIFE adult study]. / Der Zusammenhang zwischen Adipositas, sozialer Isolation und psychischer Gesundheit ­ Ergebnisse der LIFE-Adult-Studie.

BACKGROUND: Population-based studies on the relationship between social isolation and obesity, which also include younger adults, are still lacking in Germany. The aim of this study is to investigate the prevalence of social isolation in people with and without obesity. In addition, socially isolated people with and without obesity are examined with regard to socio-demographic and socio-economic factors as well as with regard to depressive symptoms. METHODS: This study was based on baseline data from the LIFE Adult Study (18-79 years) from the 2011-2014 study period. The sample comprised n = 8350 participants. In addition to socio-demographic characteristics and socio-economic status (SES), data on social isolation (LSNS-6), depression (ADS), and body mass index (BMI) were collected. Evaluations were carried out using inferential statistical analyses. RESULTS: Overall, 13.1% of the total sample were affected by social isolation. Participants with obesity (20.4%) had a significantly (p < 0.001) higher prevalence compared to those without obesity (11.4%). A better social integration was significantly associated with younger age (p < 0.001), female sex (p < 0.001), being married (and cohabiting) (p < 0.001), higher socioeconomic status (p < 0.001), and lower depressive symptoms (p < 0.001). DISCUSSION: A higher BMI was not associated per se with poorer social integration. However, the present study showed that socially isolated people with obesity represent a special risk group for impaired mental health and had twice the prevalence of social isolation compared to those without obesity.

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.

Social connections and risk of incident mild cognitive impairment, dementia, and mortality in 13 longitudinal cohort studies of ageing.

INTRODUCTION: Previous meta-analyses have linked social connections and mild cognitive impairment, dementia, and mortality. However, these used aggregate data from North America and Europe and examined a limited number of social connection markers. METHODS: We used individual participant data (N = 39271, Mage  = 70.67 (40-102), 58.86% female, Meducation  = 8.43 years, Mfollow-up  = 3.22 years) from 13 longitudinal ageing studies. A two-stage meta-analysis of Cox regression models examined the association between social connection markers with our primary outcomes. RESULTS: We found associations between good social connections structure and quality and lower risk of incident mild cognitive impairment (MCI); between social structure and function and lower risk of incident dementia and mortality. Only in Asian cohorts, being married/in a relationship was associated with reduced risk of dementia, and having a confidante was associated with reduced risk of dementia and mortality. DISCUSSION: Different aspects of social connections - structure, function, and quality - are associated with benefits for healthy aging internationally. HIGHLIGHTS: Social connection structure (being married/in a relationship, weekly community group engagement, weekly family/friend interactions) and quality (never lonely) were associated with lower risk of incident MCI. Social connection structure (monthly/weekly friend/family interactions) and function (having a confidante) were associated with lower risk of incident dementia. Social connection structure (living with others, yearly/monthly/weekly community group engagement) and function (having a confidante) were associated with lower risk of mortality. Evidence from 13 longitudinal cohort studies of ageing indicates that social connections are important targets for reducing risk of incident MCI, incident dementia, and mortality. Only in Asian cohorts, being married/in a relationship was associated with reduced risk of dementia, and having a confidante was associated with reduced risk of dementia and mortality.

Sex differences in dementia risk and risk factors: Individual-participant data analysis using 21 cohorts across six continents from the COSMIC consortium.

INTRODUCTION: Sex differences in dementia risk, and risk factor (RF) associations with dementia, remain uncertain across diverse ethno-regional groups. METHODS: A total of 29,850 participants (58% women) from 21 cohorts across six continents were included in an individual participant data meta-analysis. Sex-specific hazard ratios (HRs), and women-to-men ratio of hazard ratios (RHRs) for associations between RFs and all-cause dementia were derived from mixed-effect Cox models. RESULTS: Incident dementia occurred in 2089 (66% women) participants over 4.6 years (median). Women had higher dementia risk (HR, 1.12 [1.02, 1.23]) than men, particularly in low- and lower-middle-income economies. Associations between longer education and former alcohol use with dementia risk (RHR, 1.01 [1.00, 1.03] per year, and 0.55 [0.38, 0.79], respectively) were stronger for men than women; otherwise, there were no discernible sex differences in other RFs. DISCUSSION: Dementia risk was higher in women than men, with possible variations by country-level income settings, but most RFs appear to work similarly in women and men.

Physical activity and mental health: the connection between step count and depression, anxiety and quality of sleep.

While there are studies connecting everyday physical activity (PA) to mental health, they mostly use self-report measures for PA which are biased in multiple ways. Nevertheless, a realistic assessment of everyday PA is important for the development and implementation of low-threshold public health interventions. Therefore, we want to analyze the relationship between objectively measured daily steps and mental health. We included 1451 subjects from a subsample of the population-based LIFE-Adult-Study (2011-2014) with an average age of 55.0 years, 52.1% were female. We analyzed the effects of PA (step count measured via SenseWear Pro 3) on depression (CES-D), anxiety (GAD-7), and quality of sleep (PSQI). The regression analysis showed a significant negative association between low to moderate PA [Incidence rate ratio: 0.87 (0.77; 0.98)] as well as high to very high PA [0.84 (0.74; 0.95)] and depression and no significant associations between PA and anxiety [l-m: 0.98 (0.81; 1.18)/h-vh: 1.00 (0.82; 1.21)] or quality of sleep [l-m: 0.94 (0.84, 1.06)/h-vh: 0.92 (0.82, 1.03)], controlling for sociodemographic variables and personality. Low-threshold interventions that increase daily step count could be a useful approach for the prevention of depression. The use of objective PA measurement for research is highly encouraged.

[The development of mental health in oldest-old individuals during the COVID-19 pandemic and the role of social support]. / Die Entwicklung der psychischen Gesundheit bei hochaltrigen Individuen während der COVID-19-Pandemie und die Rolle sozialer Unterstützung.

BACKGROUND: The elderly population is one of the high-risk groups with regard to a severe course of disease and increased mortality when infected with the coronavirus SARS-CoV­2 (Severe Acute Raspiratory Syndrom Coronavirus 2). This group may be at higher risk for psychological strains from the COVID-19 pandemic itself but also from the health protection measures. The aim is to examine how symptoms of depressiveness, anxiety, and somatization change over the course of the pandemic and which role social support plays in that. METHODS: Using two written surveys of n = 156 elderly participants in the periods May to June 2020 and March to May 2021, sociodemographic data, factors of psychological strain (depressiveness, anxiety, and somatization), as well as the perceived social support were recorded. The mean age of the respondents was 87.20 years (SD = 4.65; age range = 77.68-96.75 years) and 88.03 years (SD = 4.63; age range = 78.52-97.62 years) for 2020 and 2021, respectively. Data were analyzed using Wilcoxon t­tests and generalized linear regression models. RESULTS: A significant increase in the expression of psychological strain with regards to depressiveness, anxiety, and somatization can be identified. Higher scores of psychological strains in 2020 are associated with a higher psychological strain in 2021. Higher perceived social support in 2020 is associated with lower depressiveness one year later. CONCLUSION: An increase in psychological strain has been observed in the elderly population over the course of the COVID-19 pandemic until May 2021. This population should be supported by preventive programs to avert a further increase in symptoms. The expansion of social support could be useful, especially in the prevention of depressive symptoms.

Factors Leading to Institutionalization among the Oldest Old: Longitudinal Findings from the AgeCoDe-AgeQualiDe Study.

INTRODUCTION: Due to the strong association between old age and the need for long-term care, the number of individuals in need for care is projected to increase noticeably. The aim of this study was to examine the determinants of institutionalization among the oldest old longitudinally. METHODS: Longitudinal data (follow-up [FU] wave 7-9) were gathered from 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). At FU wave 7, in 2014, complete measures were available for 763 individuals. The average age was 88.9 (standard deviation 2.9) years (range 85-100), and 68% were female. Sociodemographic and health-related independent variables (e.g., depressive symptoms or functioning) were included in the regression model. Institutionalization (admission to assisted living home or nursing home) was used as an outcome measure. Logistic random-effects models were used. RESULTS: Regressions revealed that among oldest old, the odds of being institutionalized were lower for men (odds ratio [OR] = 0.03; 95% confidence interval [CI] 0.00-0.16). Institutionalization was associated with an increased age (OR = 1.27; 95% CI 1.04-1.55). Additionally, widowed individuals (ref. non-widowed) had higher odds of being institutionalized (OR = 8.95; 95% CI 1.61-49.81). Institutionalization was also associated with functional decline (OR = 0.16; 95% CI 0.11-0.23), whereas it was not significantly associated with cognitive decline, depressive symptoms, and social support. CONCLUSION: Our findings stress the importance of gender, age, widowhood, and functional decline for institutionalization among the oldest old. Preventing or at least postponing functional decline might help to delay institutionalization as far as possible.

Connecting chronic stress and anxiety: a multi-dimensional perspective.

Studies show a connection between anxiety and stress, but with little differentiation between different domains of stress. In this article, we utilize a multi-dimensional approach to better understand the relationship between different chronic stress domains and anxiety. This will allow researchers to identify and address those areas of stress that are most relevant with regard to anxiety. We used data from a sub sample of the LIFE-Adult-Study (n = 1085) to analyze the association between nine different areas of chronic stress (Trier Inventory for Chronic Stress, TICS) and anxiety (General Anxiety Disorder 7, GAD-7), controlling for sociodemographic variables, personality, and social support. There was a significant and positive association between Work Overload, Pressure to Perform, Social Tensions, Social Isolation, Chronic Worrying, and anxiety. After including the control variables, only Work Overload and Chronic Worrying remained significant. By focusing on Work Overload and Chronic Worrying researchers, practitioners, and policy makers can help to mitigate anxiety and related health problems in the population in an efficient way.

Effects of APOE e4-allele and mental work demands on cognitive decline in old age: Results from the German Study on Ageing, Cognition, and Dementia in Primary Care Patients (AgeCoDe).

OBJECTIVES: Previous studies have observed protective effects of high mental demands at work on cognitive functioning and dementia risk. However, it is unclear what types of demands drive this effect and whether this effect is subject to a person's genetic risk. We investigated to what extent eight different types of mental demands at work together with the APOE e4 allele, a major risk gene for late-onset Alzheimer's disease, affect cognitive functioning in late life. METHODS/DESIGN: The population-based German Study on Ageing, Cognition, and Dementia in Primary Care Patients (AgeCoDe, n = 2 154) followed cognitively healthy individuals aged 75 years and older in seven assessment waves. Cognitive functioning was assessed via the mini-mental status examination. RESULTS: Mixed-effects modeling (adjusted for education, gender, marital status, stroke, depression, and diabetes) indicated that participants who had an occupational history of working in jobs with high compared to low demands in "Language & Knowledge", "Pattern detection", "Information processing", and "Service" had a slower cognitive decline. APOE e4-allele carriers had an accelerated cognitive decline, but this decline was significantly smaller if they had a medium compared to a low level of demands in contrast to non-carriers. CONCLUSIONS: Our longitudinal observations suggest that cognitive decline could be slowed by an intellectually enriched lifestyle even in risk gene carriers. Fostering intellectual engagement throughout the life-course could be a key prevention initiative to promote better cognitive health in old age.

Leipzig - Individual Placement and Support for people with mental illnesses (LIPSY): study protocol of a randomized controlled trial.

BACKGROUND: Individuals receiving means-tested benefits are at a higher risk of being diagnosed with a psychiatric illness compared to those who are employed, and the rate of those working in the first labor market is low. The intervention (Individual Placement and Support, IPS) aims at maintaining or regaining working ability and at facilitating reintegration into the (first) labor market following a "first place, then train"-approach. The objective of the study is to conduct the first RCT in Germany that addresses a broad group of long-term unemployed individuals with severe mental illnesses that receive means-tested benefits, and to test the effectiveness of the IPS intervention. METHODS: In this randomized controlled trial, about 120 eligible participants aged between 18 years and local retirement age will be randomly allocated to an intervention group (IG) or to an active control group (CG) using a parallel arm design. The IG will receive IPS + high quality treatment as usual (TAU), the active CG will receive TAU + a booklet on integration measures. A block-randomization algorithm with a targeted assignment ratio of 1:1 for participants in IG and active CG will be used, stratified by sex and three age groups. Assessments will take place before the intervention at baseline (t0), and 6 (t1), 12 (t2), and 18 (t3) months later. Primary outcome will be the proportion of participants having worked at least 1 day in competitive employment since baseline, as assessed at t3. Secondary outcomes will be related to employment/ vocation and mental health. In addition, there will be a process evaluation. Treatment effects on outcomes will be tested using appropriate panel-data regression models, and acceptability, uptake and adherence will be evaluated using descriptive statistics and appropriate inference testing. DISCUSSION: The results of this trial are expected to generate a better understanding of the efficiency, feasibility, acceptance, and relevance of the IPS intervention in a German setting. They could be a first step towards the implementation of the method and towards improving the situation of long-term unemployed individuals with severe mental health problems. TRIAL REGISTRATION: German Clinical Trials Register ( DRKS00023245 ), registered on 22.02.2021.

Employment status and desire for work in severe mental illness: results from an observational, cross-sectional study.

PURPOSE: People with a severe mental illness (SMI) are at particular risk of occupational exclusion. Among the approaches to occupational rehabilitation, supported employment (SE) has been proven to be the most effective. A requirement to enter SE-programs is that individuals must want to seek competitive employment. The aim of this work is to investigate the relationship between serious mental illness and the desire to work including potential predictors. METHODS: This is a cross-sectional observational study of patients with SMI aged 18-65 years (n = 397). Patients were interviewed by trained staff using standardised instruments. The relationship between potential predictors and a strong preference for employment were analysed using a hierarchic binary logistic regression model. RESULTS: Only about one-quarter (27.9%) of SMI patients is in competitive employment. Another quarter is unemployed (25.9%). Results show that the desire for competitive employment is strong among more than half of the SMI patients. Among the unemployed, two-thirds express a strong desire for work. These individuals are an ideal target group for SE interventions. Comorbid chronic physical illness, diagnosis, and the subjectively judged ability to work are associated with the desire for work. CONCLUSION: Our data confirm a substantial exclusion of individuals with SMI from the workforce. In general, care needs for workplace interventions are not being met and leave much room for improvement. In addition to employment status, the desire for work should be routinely assessed. STUDY REGISTRATION: The study was registered in the German Clinical Trials Register (DRKS) ( https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015801 ) and under the WHO-Platform "International Clinical Trials Registry Platform" (ICTRP) ( https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00015801 ) under the registration number DRKS00015801 before the start of recruitment (Registration date: 21.02.2019).

Using a brief web-based 5A intervention to improve weight management in primary care: results of a cluster-randomized controlled trial.

BACKGROUND: The primary health care setting is considered a major starting point in successful obesity management. However, research indicates insufficient quality of weight counseling in primary care. Aim of the present study was to implement and evaluate a 5A online tutorial aimed at improving weight management and provider-patient-interaction in primary health care. The online tutorial is a stand-alone low-threshold minimal e-health intervention for general practitioners based on the 5As guidance for obesity management by the Canadian Obesity Network. METHODS: In a cluster-randomized controlled trial, 50 primary care practices included 160 patients aged 18 to 60 years with obesity (BMI ≥ 30). The intervention practices had continuous access to the 5A online tutorial for the general practitioner. Patients of control practices were treated as usual. Primary outcome was the patients' perspective of the doctor-patient-interaction regarding obesity management, assessed with the Patient Assessment of Chronic Illness Care before and after (6/12 months) the training. Treatment effects over time (intention-to-treat) were evaluated using mixed-effects linear regression models. RESULTS: More than half of the physicians (57%) wished for more training offers on obesity counseling. The 5A online tutorial was completed by 76% of the physicians in the intervention practices. Results of the mixed-effects regression analysis showed no treatment effect at 6 months and 12 months' follow-up for the PACIC 5A sum score. Patients with obesity in the intervention group scored lower on self-stigma and readiness for weight management compared to participants in the control group at 6 months' follow-up. However, there were no significant group differences for weight, quality of life, readiness to engage in weight management, self-stigma and depression at 12 months' follow-up. CONCLUSION: To our knowledge, the present study provides the first long-term results for a 5A-based intervention in the context of the German primary care setting. The results suggest that a stand-alone low-threshold minimal e-health intervention for general practitioners does not improve weight management in the long term. To improve weight management in primary care, more comprehensive strategies are needed. However, due to recruitment difficulties the final sample was smaller than intended. This may have contributed to the null results. TRIAL REGISTRATION: The study has been registered at the German Clinical Trials Register (Identifier: DRKS00009241 , Registered 3 February 2016).