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Item A multidomain intervention against cognitive decline in an at-risk-population in Germany: Results from the cluster-randomized AgeWell.de trial.(John Wiley and Sons, Inc., 2024-01-01) Zülke AE; Pabst A; Luppa M; Roehr S; Seidling H; Oey A; Cardona MI; Blotenberg I; Bauer A; Weise S; Zöllinger I; Sanftenberg L; Brettschneider C; Döhring J; Lunden L; Czock D; Haefeli WE; Wiese B; Hoffmann W; Frese T; Gensichen J; König H-H; Kaduszkiewicz H; Thyrian JR; Riedel-Heller SGINTRODUCTION: 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.Item 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)(John Wiley and Sons Ltd, 2021-01) Rodriguez FS; Roehr S; Pabst A; Kleineidam L; Fuchs A; Wiese B; Lühmann D; Brettschneider C; Wolfsgruber S; Pentzek M; van den Bussche H; König H-H; Weyerer S; Werle J; Bickel H; Weeg D; Maier W; Scherer M; Wagner M; Riedel-Heller SGObjectives 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.Item Prospective Associations between Single Foods, Alzheimer’s Dementia and Memory Decline in the Elderly(MDPI (Basel, Switzerland), 2018-07) Fischer K; Melo van Lent D; Wolfsgruber S; Weinhold L; Kleineidam L; Bickel H; Scherer M; Eisele M; van den Bussche H; Wiese B; König H-H; Weyerer S; Pentzek M; Röhr S; Maier W; Jessen F; Schmid M; Riedel-Heller SG; Wagner MBackground: Evidence whether single “cognitive health” foods could prevent cognitive decline is limited. We investigated whether dietary intake of red wine, white wine, coffee, green tea, olive oil, fresh fish, fruits and vegetables, red meat and sausages, assessed by a single-food-questionnaire, would be associated with either incident Alzheimer’s dementia (AD) or verbal memory decline. Methods: Participants aged 75+ of the German Study on Aging, Cognition and Dementia in Primary Care Patients (AgeCoDe) cohort were regularly followed over 10 years (n = 2622; n = 418 incident AD cases). Multivariable-adjusted joint modeling of repeated-measures and survival analysis was used, taking gender and Apolipoprotein E4 (APOE ε4) genotype into account as possible effect modifiers. Results: Only higher red wine intake was associated with a lower incidence of AD (HR = 0.92; P = 0.045). Interestingly, this was true only for men (HR = 0.82; P < 0.001), while in women higher red wine intake was associated with a higher incidence of AD (HR = 1.15; P = 0.044), and higher white wine intake with a more pronounced memory decline over time (HR = −0.13; P = 0.052). Conclusion: We found no evidence for these single foods to be protective against cognitive decline, with the exception of red wine, which reduced the risk for AD only in men. Women could be more susceptible to detrimental effects of alcohol.Item Disentangling the relationship of subjective cognitive decline and depressive symptoms in the development of cognitive decline and dementia(Wiley Periodicals LLC on behalf of Alzheimer's Association, 2023-05) Kleineidam L; Wagner M; Guski J; Wolfsgruber S; Miebach L; Bickel H; König H-H; Weyerer S; Lühmann D; Kaduszkiewicz H; Luppa M; Röhr S; Pentzek M; Wiese B; Maier W; Scherer M; Kornhuber J; Peters O; Frölich L; Wiltfang J; Lewczuk P; Hüll M; Ramirez A; Jessen F; Riedel-Heller SG; Heser KIntroduction 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.Item HELP@APP: development and evaluation of a self-help app for traumatized Syrian refugees in Germany – a study protocol of a randomized controlled trial(BioMed Central Ltd, 2019-04-30) Golchert J; Roehr S; Berg F; Grochtdreis T; Hoffmann R; Jung F; Nagl M; Plexnies A; Renner A; König H-H; Kersting A; Riedel-Heller SGBackground Syrians represent the largest group among refugees in Germany. Many of them were exposed to sequential traumatizing events including war, escape and post-migration stressors, which significantly increase the risk to develop symptoms of posttraumatic stress and other mental disorders. However, there is a lack of adequate treatment options for traumatized refugees in Germany. Moreover, their access to psychosocial care is often restricted due to legal regulation, language barriers, and unclear cost coverage. We therefore aim to develop a low-threshold supportive self-help app for Syrian refugees with posttraumatic stress symptoms. By conducting a randomized controlled trial, we further aim to evaluate the apps’ efficacy, usability, acceptance, and economic health benefit/cost-effectiveness. Methods We will develop a modular, interactive self-help app in Arabic, which will be grounded on cognitive-behavioral models for the treatment of posttraumatic stress. Subsequently, screened positive (i.e., Syrian refugees, 18–65 years old, mild to moderate posttraumatic stress symptomatology as quantified by the Posttraumatic Stress Diagnostic Scale for DSM-5/PDS-5) participants (ideally up to n = 234) will be randomly allocated to an intervention (IG) and control group (CG), respectively. Participants in the IG will gain access to the self-help app for one month, while participants in the CG will receive psychoeducational reading material in form of a comprehensive brochure on traumatization and posttraumatic stress. Measurements are scheduled before the intervention (T0), directly after the intervention (T1, one month later) and three months after the intervention (T2). Using linear mixed effect models, we will investigate change in posttraumatic symptomatology. We will also test for changes in secondary outcomes such as depression, anxiety, and quality of life. Moreover, we will inspect the usability and user acceptance of the app. To evaluate the app in terms of its economic health benefit, the incremental cost-effectiveness ratio will be calculated. Discussion We plan to make the app freely available to the general public after evaluation. Thus, the app can help to add-on to routine care, which currently lacks sufficient and appropriate treatment options for Syrian refugees. Trial registration German Clinical Trials Register/Deutsches Register Klinischer Studien (DRKS). Registration ID: DRKS00013782. Registered: 06th of July 2018.Item Lifestyle Aspects As A Predictor Of Pain Among Oldest-Old Primary Care Patients – A Longitudinal Cohort Study(Dove Medical Press, 2019-11) Mallon T; Eisele M; König H-H; Brettschneider C; Röhr S; Pabst A; Weyerer S; Werle J; Mösch E; Weeg D; Fuchs A; Pentzek M; Heser K; Wiese B; Kleineidam L; Wagner M; Riedel-Heller S; Maier W; Scherer MPurpose: Dealing with the high prevalence of pain among the oldest-old (+75) is becoming a major health issue. Therefore, the aim of the study was to uncover health-related lifestyle behaviors (HLB) and age-related comorbidities which may predict, influence and prevent pain in old age. Patients and methods: In this longitudinal cohort study, data were obtained initially from 3.327 individuals aged 75+ from over 138 general practitioners (GP) during structured clinical interviews in 2003. Nine follow-ups (FU) were assessed until 2017. Available data from 736 individuals scoring in FU3 and FU7 were included in this analysis. Data were assembled in an ambulatory setting at participant’s homes. Associations were tested using a linear regression model (model 1) and ordered logistic regression model (model 2). Results: Statistical analyses revealed increased likelihood to experience pain for participants with comorbidities such as peripheral arterial disease (PAD) (coef. 13.51, P>t = 0.00) or chronic back pain (CBP) (coef. 6.64, P>t = 0.003) or higher body mass index (BMI) (coef. 0.57, P>t = 0.015) and, female gender (coef. 6.00, SE 3.0, t = 2.02, P>t = 0.044). Participants with medium education and former smokers showed significantly lower pain rating (coef. −5.05, P>t = 0.026; coef. −5.27, P>t = 0.026). Suffering from chronic back pain (OR = 2.03), osteoarthritis (OR = 1.49) or depressive symptoms (OR = 1.10) raised the odds to experience impairments in daily living due to pain. Physical activity showed no significant results. Conclusion: Chronic conditions such as PAD, or CBP, female gender and higher BMI may increase the risk of experiencing more pain while successful smoking cessation can lower pain ratings at old age. Early and consistent support through GPs should be given to older patients in order to prevent pain at old age.Item Do self-reported hearing and visual impairments predict longitudinal dementia in older adults?(Wiley Periodicals LLC on behalf of The American Geriatrics Society, 2021-06) Pabst A; Bär J; Röhr S; Löbner M; Kleineidam L; Heser K; Hajek A; van der Leeden C; Wiese B; Maier W; Angermeyer MC; Scherer M; Wagner M; König H-H; Riedel-Heller SGBackground Sensory impairments have been associated with dementia in older adults. However, the contribution of different impairments and how they interact in the development of dementia is not clear. We examined the independent and interaction effects of hearing impairment (HI) and visual impairment (VI) on incident dementia. Design Multi-centric population-based prospective cohort study. Setting Data were taken from the AgeDifferent.de platform, pooling participants aged 75 and older from the German LEILA75+ and AgeCoDe/AgeQualiDe cohorts. Participants Older adults (N = 3497) with mean age 79.8 years, 67.2% female. Measurements Standardized interviews and questionnaires were used to assess self-reported HI and VI at baseline and all-cause dementia in 9 follow-ups, spanning over 20 years. Methods Competing risk regression models were conducted to test the main and interaction effects of HI and VI on dementia incidence, adjusting for established risk factors of dementia and accumulated mortality. Results HI and VI at baseline were reported by 30.3% and 16.6% of individuals, respectively. Adjusting for baseline information on sociodemographics, substance use, cognitive functioning and morbidity, and controlling for accumulated mortality risk, HI (sHR 1.16, 95% CI 1.04–1.30, p = 0.011) but not VI (sHR 1.07, 95% CI 0.90–1.28, p = 0.462) was significantly associated with incident dementia. There was no interaction between HI and VI (sHR 1.09, 95% CI 0.81–1.46, p = 0.567). Conclusions Hearing impairment is associated with an increased incidence of all-cause dementia in older adults. There is no excess risk or risk compensation through the additional presence or absence of visual impairment. Early prevention measures for hearing impairment might help to reduce the long-term risk of dementia.Item Recruitment and Baseline Characteristics of Participants in the AgeWell.de Study—A Pragmatic Cluster-Randomized Controlled Lifestyle Trial against Cognitive Decline(MDPI (Basel, Switzerland), 2021-01) Röhr S; Zülke A; Luppa M; Brettschneider C; Weißenborn M; Kühne F; Zöllinger I; Samos F-AZ; Bauer A; Döhring J; Krebs-Hein K; Oey A; Czock D; Frese T; Gensichen J; Haefeli WE; Hoffmann W; Kaduszkiewicz H; König H-H; Thyrian JR; Wiese B; Riedel-Heller SGTargeting dementia prevention, first trials addressing multiple modifiable risk factors showed promising results in at-risk populations. In Germany, AgeWell.de is the first large-scale initiative investigating the effectiveness of a multi-component lifestyle intervention against cognitive decline. We aimed to investigate the recruitment process and baseline characteristics of the AgeWell.de participants to gain an understanding of the at-risk population and who engages in the intervention. General practitioners across five study sites recruited participants (aged 60–77 years, Cardiovascular Risk Factors, Aging, and Incidence of Dementia/CAIDE dementia risk score ≥ 9). Structured face-to-face interviews were conducted with eligible participants, including neuropsychological assessments. We analyzed group differences between (1) eligible vs. non-eligible participants, (2) participants vs. non-participants, and (3) between intervention groups. Of 1176 eligible participants, 146 (12.5%) dropped out before baseline; the study population was thus 1030 individuals. Non-participants did not differ from participants in key sociodemographic factors and dementia risk. Study participants were M = 69.0 (SD = 4.9) years old, and 52.1% were women. The average Montreal Cognitive Assessment/MoCA score was 24.5 (SD = 3.1), indicating a rather mildly cognitively impaired study population; however, 39.4% scored ≥ 26, thus being cognitively unimpaired. The bandwidth of cognitive states bears the interesting potential for differential trial outcome analyses. However, trial conduction is impacted by the COVID-19 pandemic, requiring adjustments to the study protocol with yet unclear methodological consequences.Item Prevalence of pain and its associated factors among the oldest-olds in different care settings – results of the AgeQualiDe study(BioMed Central Ltd, 2018) Mallon T; Ernst A; Brettschneider C; König H-H; Luck T; Röhr S; Weyerer S; Werle J; Mösch E; Weeg D; Fuchs A; Pentzek M; Kleineidam L; Heser K; Riedel-Heller S; Maier W; Wiese B; Scherer M; AgeCoDe & AgeQualiDe study groupBackground The prevalence of pain is very common in the oldest age group. Managing pain successfully is a key topic in primary care, especially within the ageing population. Different care settings might have an impact on the prevalence of pain and everyday life. Methods Participants from the German longitudinal cohort 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) were asked to rate their severity of pain as well as the impairment with daily activities. Besides gender, age, education, BMI and use of analgesics we focused on the current housing situation and on cognitive state. Associations of the dependent measures were tested using four ordinal logistic regression models. Model 1 and 4 consisted of the overall sample, model 2 and 3 were divided according to no cognitive impairment (NCI) and mild cognitive impairment (MCI). Results Results show a decline in pain at very old age but nonetheless a high prevalence among the 85+ year olds. Sixty-three per cent of the participants report mild to severe pain and 69% of the participants mild to extreme impairment due to pain with daily activities. Use of analgesics, depression and living at home with care support are significantly associated with higher and male gender with lower pain ratings. Conclusions Sufficient pain management among the oldest age group is inevitable. Outpatient care settings are at risk of overlooking pain. Therefore focus should be set on pain management in these settings.Item A Self-Help App for Syrian Refugees With Posttraumatic Stress (Sanadak): Randomized Controlled Trial(JMIR Publications, 2021-01) Röhr S; Jung FU; Pabst A; Grochtdreis T; Dams J; Nagl M; Renner A; Hoffmann R; König H-H; Kersting A; Riedel-Heller SGBackground: Syrian refugees residing in Germany often develop posttraumatic stress as a result of the Syrian civil war, their escape, and postmigration stressors. At the same time, there is a lack of adequate treatment options. The smartphone-based app Sanadak was developed to provide cognitive behavioral therapy–based self-help in the Arabic language for Syrian refugees with posttraumatic stress. Objective: The aim of this study was to evaluate the effectiveness and cost-effectiveness of the app. Methods: In a randomized controlled trial, eligible individuals were randomly allocated to the intervention group (IG; app use) or control group (CG; psychoeducational reading material). Data were collected during structured face-to-face interviews at 3 assessments (preintervention/baseline, postintervention/after 4 weeks, follow-up/after 4 months). Using adjusted mixed-effects linear regression models, changes in posttraumatic stress and secondary outcomes were investigated as intention-to-treat (ITT) and per-protocol (PP) analysis. Cost-effectiveness was evaluated based on adjusted mean total costs, quality-adjusted life years (QALYs), and cost-effectiveness acceptability curves using the net benefit approach. Results: Of 170 screened individuals (aged 18 to 65 years), 133 were eligible and randomized to the IG (n=65) and CG (n=68). Although there was a pre-post reduction in posttraumatic stress, ITT showed no significant differences between the IG and CG after 4 weeks (Posttraumatic Diagnostic Scale for DSM-5, Diff –0.90, 95% CI –0.24 to 0.47; P=.52) and after 4 months (Diff –0.39, 95% CI –3.24 to 2.46; P=.79). The same was true for PP. Regarding secondary outcomes, ITT indicated a treatment effect for self-stigma: after 4 weeks (Self-Stigma of Mental Illness Scale/SSMIS–stereotype agreement: d=0.86, 95% CI 0.46 to 1.25; stereotype application: d=0.60, 95% CI 0.22 to 0.99) and after 4 months (d=0.52, 95% CI 0.12 to 0.92; d=0.50, 95% CI 0.10 to 0.90), the IG showed significantly lower values in self-stigma than the CG. ITT showed no significant group differences in total costs and QALYs. The probability of cost-effectiveness was 81% for a willingness-to-pay of €0 per additional QALY but decreased with increasing willingness-to-pay. Conclusions: Sanadak was not more effective in reducing mild to moderate posttraumatic stress in Syrian refugees than the control condition nor was it likely to be cost-effective. Therefore, Sanadak is not suitable as a standalone treatment. However, as the app usability was very good, no harms detected, and stigma significantly reduced, Sanadak has potential as a bridging aid within a stepped and collaborative care approach. Trial Registration: German Clinical Trials Register DRKS00013782; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013782 International Registered Report Identifier (IRRID): RR2-10.1186/s12888-019-2110-y