Prevention at home in older persons with (pre-)frailty: analysis of participants' recruitment and characteristics of the randomized controlled PromeTheus trial.

BACKGROUND: The "PromeTheus" trial is evaluating a home-based, multifactorial, interdisciplinary prevention program for community-dwelling (pre-)frail older adults. These individuals often suffer from reduced participation, which can complicate the recruitment and enrollment in a clinical trial. AIMS: The aim of this study was to evaluate different recruitment strategies and differences in participant characteristics in relation to these strategies. METHODS: This cross-sectional study used baseline data from the randomized-controlled PromeTheus trial, in which community-dwelling (pre-)frail older persons (Clinical Frailty Scale [CFS] 4-6 pt., ≥ 70 years) were recruited via general practitioners ("GP recruitment") or flyers, newspaper articles, and personalized letters ("direct recruitment"). Differences in the sociodemographic, clinical, physical, functional, mobility-related, psychological and social characteristics were analyzed in relation to the recruitment strategy. RESULTS: A total of 385 participants (mean age = 81.2, SD 5.9 years; women: n = 283, 73.5%) were enrolled, of which 60 (16%) were recruited by GPs and 325 (84%) through direct recruitment. Participants recruited via GPs had significantly higher subjective frailty levels (CFS), were more often physically frail (Fried Frailty Phenotype), and showed lower physical capacity (Short Physical Performance Battery), participation (disability component of the short version of the Late-Life Function and Disability Instrument), and life-space mobility (Life-Space Assessment) compared to those recruited via the direct approach (p = 0.002-0.026). Costs per randomized participant were 94€ for the GP recruitment strategy and €213 for the direct recruitment strategy. CONCLUSION: Different strategies may be required to successfully recruit (pre-)frail home-living older adults into preventive programs. Direct recruitment strategies, in which potential participants are directly informed about the prevention program, seem to be more promising than GP recruitment but may result in enrolment of persons with less functional impairment and higher recruitment costs. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00024638. Registered on March 11, 2021.

Association of two geriatric treatment systems with anti-osteoporotic drug treatment and second hip fracture in patients with an index hip fracture: retrospective cohort study.

BACKGROUND: In Germany, geriatricians deliver acute geriatric care during acute hospital stay and post-acute rehabilitation after transfer to a rehabilitation clinic. The rate patients receive acute geriatric care (AGC) or are transferred to post-acute rehabilitation (TPR) differs between hospitals. This study analyses the association between the two geriatric treatment systems (AGC, TPR) and second hip fracture in patients following an index hip fracture. METHODS: Nationwide health insurance data are used to identify the rate of AGC and TPR per hospital following hip fracture surgery in patients aged ≥ 80 years. Outcomes are a second hip fracture after surgery or after discharge within 180 or 360 days and new specific anti-osteoporotic drugs. Cox proportional hazard models and generalised linear models are applied. RESULTS: Data from 29,096 hip fracture patients from 652 hospitals were analysed. AGC and TPR are not associated with second hip fracture when follow-up started after surgery. However, during the first months after discharge patients from hospitals with no AGC or low rates of TPR have higher rates of second hip fracture than patients from hospitals with high rates of AGC or high rates of TPR (Hazard Ratio (95% CI) 1.35 (1.01-1.80) or 1.35 (1.03-1.79), respectively). Lower rates of AGC are associated with lower probabilities of new prescriptions of specific anti-osteoporotic drugs. CONCLUSIONS: Our study suggests beneficial relationships of geriatric treatment after hip fracture with a) the risk of second hip fractures during the first months after discharge and b) an improvement of anti-osteoporotic drug treatment.

Multimodal home-based rehabilitation intervention after discharge from inpatient geriatric rehabilitation (GeRas): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Geriatric rehabilitation aims to maintain the functional reserves of older adults in order to optimize social participation and prevent disability. After discharge from inpatient geriatric rehabilitation, patients are at high risk for decreased physical capacity, increased vulnerability, and limitations in mobility. As a result, ageing in place becomes uncertain for a plethora of patients after discharge from geriatric rehabilitation and effective strategies to prevent physical decline are required. Collaboration between different health-care providers is essential to improve continuity of care after discharge from inpatient geriatric rehabilitation. The aim of this study is to evaluate the effectiveness of a multi-professional home-based intervention program (GeRas) to improve functional capacity and social participation in older persons after discharge from inpatient geriatric rehabilitation. METHODS: The study is a multicenter, three-arm, randomized controlled trial with a three-month intervention period. Two hundred and seventy community-dwelling older people receiving inpatient geriatric rehabilitation will be randomized with a 1:1:1 ratio to one of the parallel intervention groups (conventional IG or tablet IG) or the control group (CG). The participants of both IGs will receive a home-based physical exercise program supervised by physical therapists, a nutritional recommendation by a physician, and social counseling by social workers of the health insurance company. The collaboration between the health-care providers and management of participants will be realized within a cloud environment based on a telemedicine platform and supported by multi-professional case conferences. The CG will receive usual care, two short handouts on general health-related topics, and facultative lifestyle counseling with general recommendations for a healthy diet and active ageing. The primary outcomes will be the physical capacity measured by the Short Physical Performance Battery and social participation assessed by the modified Reintegration to Normal Living Index, three months after discharge. DISCUSSION: The GeRas program is designed to improve the collaboration between health-care providers in the transition from inpatient geriatric rehabilitation to outpatient settings. Compared to usual care, it is expected to improve physical capacity and participation in geriatric patients after discharge from inpatient geriatric rehabilitation. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00029559). Registered on October 05, 2022.

[Cooperation of geriatrics and trauma surgery in certified geriatric trauma centers : Insights into different care models and the implementation of requirements resulting from certification]. / Zusammenarbeit von Geriatrie und Unfallchirurgie in zertifizierten alterstraumatologischen Zentren : Einblicke in unterschiedliche Versorgungsmodelle und in die Umsetzung von Anforderungen, die sich aus der Zertifizierung ergeben.

BACKGROUND: In Germany, different models of orthogeriatric co-management have been implemented in certified geriatric trauma centers. So far, it is not clear how the different models are implemented and what influence the certification has on the structures and processes within the centers. The present study examined the extent of cooperation between surgery and geriatrics and if the quality of care had changed since the certification of the centers. METHODS: In this study 4 guided focus group interviews (FGI) were conducted in different teams of certified geriatric trauma centers in 3 federal states with 16 participants. To specify the content of the FGI, two additional interviews were conducted with system auditors. Both types of interview were analyzed by content analysis. RESULTS: The certification supported the implementation of structures and processes in the different orthogeriatric models; however, the quality of care and cooperation between surgery and geriatrics depends on the spatial proximity and the orthogeriatric care model in the geriatric trauma centers. Simultaneously, challenges in the area of geriatric syndromes and the recruitment of skilled staff became relevant. DISCUSSION: The results can help to reflect processes in the certified geriatric trauma centers and to treat geriatric syndromes more effectively. In the future, the challenge will be to establish geriatric care under the existing shortage of skilled staff.

Evaluation of costs, osteoporosis treatment, and re-fractures in German collaborative orthogeriatric care after fragility fractures.

Orthogeriatric co-management (OGCM) may provide benefits for geriatric fragility fracture patients in terms of more frequent osteoporosis treatment and fewer re-fractures. Yet, we did not find higher costs in OGCM hospitals for re-fractures or antiosteoporotic medication for most fracture sites within 12 months, although antiosteoporotic medication was more often prescribed. PURPOSE: Evidence suggests benefits of orthogeriatric co-management (OGCM) for hip fracture patients. Yet, evidence for other fractures is rare. The aim of our study was to conduct an evaluation of economic and health outcomes after the German OGCM for geriatric fragility fracture patients. METHODS: This retrospective cohort study was based on German health and long-term care insurance data. Individuals were 80 years and older, sustained a fragility fracture in 2014-2018, and were treated in hospitals certified for OGCM (ATZ group), providing OGCM without certification (OGCM group) or usual care (control group). Healthcare costs from payer perspective, prescribed medications, and re-fractures were investigated within 6 and 12 months. We used weighted gamma and two-part models and applied entropy balancing to account for the lack of randomization. All analyses were stratified per fracture site. RESULTS: We observed 206,273 patients within 12-month follow-up, of whom 14,100 were treated in ATZ, 133,353 in OGCM, and 58,820 in other hospitals. Total average inpatient costs per patient were significantly higher in the OGCM and particularly ATZ group for all fracture sites, compared to control group. We did not find significant differences in costs for re-fractures or antiosteoporotic medication for most fracture sites, although antiosteoporotic medication was significantly more often observed in the OGCM and particularly ATZ group for hip, pelvic, and humerus fractures. CONCLUSION: The observed healthcare costs were higher in ATZ and OGCM hospitals within 12 months. Antiosteoporotic medication was prescribed more often in both groups for most fracture sites, although the corresponding medication costs did not increase.

Long-Term Mortality of Patients With Osteoarthritis After Joint Replacement: Prognostic Value of Preoperative and Postoperative Pain and Function.

OBJECTIVE: To investigate whether osteoarthritis (OA)-specific assessment values (i.e., Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) and generic pain and function (visual analog scale, Hanover Functionality Status Questionnaire) measured before and 12 months after arthroplasty are associated with the risk of long-term mortality in a cohort of patients with advanced OA of the hip or knee. METHODS: The Ulm Osteoarthritis Study was a prospective cohort study of OA patients with unilateral total hip or knee replacement between January 1995 and December 1996. Correlation coefficients were calculated to describe the agreement between the different assessments. Mortality was assessed during the follow-up period (last update July 2019). Cox proportional regression models were used to estimate hazard ratios (HRs) for mortality after adjusting for covariates. RESULTS: Arthroplasty was accompanied by a clear reduction in pain and improved function throughout all assessments in the 706 included patients. The results of the adjusted Cox models showed no relationship between baseline and follow-up joint-specific WOMAC assessments and long-term mortality. However, an independent increased risk of mortality was found with generic function assessments. In the final adjusted model, the HR for the 12-month follow-up value was 1.79 (95% confidence interval 1.24-2.60) in the group with clinically relevant impairment versus the reference group. CONCLUSION: Poor function based on the generic assessment was associated with increased long-term mortality, suggesting that functional impairments in daily life activities may be more important for long-term survival than OA-specific impairments in this patient group.

Health-Economic Evaluation of the German Osteoporotic Fracture Prevention Program in Rural Areas (OFRA): Mobility and Falls Prevention Classes, Examination of Bone Health, and Consultation on Safety in the Living Environment.

BACKGROUND: Fragility fractures are one of the leading causes of disability in older adults. Yet, evidence for effectiveness and cost-effectiveness of preventive approaches combining bone health and fall prevention is rare. OBJECTIVE: To conduct a health-economic evaluation of the German osteoporotic fracture prevention program in rural areas (OFRA). DESIGN: Secondary cluster-randomized intervention study based on routine data. PARTICIPANTS: All districts in five federal states in Germany were cluster-randomized as intervention or control districts. OFRA was offered to community-living (a) women aged 75-79 years or (b) women and men aged 70-84 years with a prior fragility fracture in the intervention districts. Individuals who meet these criteria in the control districts were assigned to the control group. INTERVENTION: OFRA comprised mobility and falls prevention classes, examination of bone health by bone density measurement, and consultation on safety in the home living environment. MAIN MEASURES: We measured health-care costs and effectiveness in terms of time to fragility fracture or death within 1 year after initial contact, based on health insurance claims data. Implementation costs were recorded by the intervention performers. We calculated an incremental cost-effectiveness ratio (ICER) and employed the net-benefit approach to construct a cost-effectiveness acceptability curve (CEAC). KEY RESULTS: There were 9408 individuals in the intervention group and 27,318 in the control group. Mean time to fragility fracture or death (difference: 0.82 days) and health-care costs (difference: 111.73€, p < .01) were reduced, but mean intervention costs (difference: 260.10€) increased total costs (difference: 148.37€, p < .001) in the intervention group. The ICER per fracture-free year of survival was 66,094.63€. The CEAC showed no acceptable probability of cost-effectiveness at a reasonable willingness to pay. CONCLUSION: OFRA showed reduced rates of fragility fractures, but had high implementation costs, resulting in an unfavorable ICER. The cost-effectiveness of OFRA may improve with a longer follow-up.

Association of clinical outcome assessments of mobility capacity and incident disability in community-dwelling older adults - a systematic review and meta-analysis.

The objective of the present review is to synthesize all available research on the association between mobility capacity and incident disability in non-disabled older adults. MEDLINE, EMBASE and CINAHL databases were searched without any limits or restrictions until February 2021. Published reports of longitudinal cohort studies that estimated a direct association between baseline mobility capacity, assessed with a standardized outcome assessment, and subsequent development of disability, including initially non-disabled older adults were included. The risk of bias was assessed using the Quality in Prognosis Studies (QUIPS) tool. Random-effect models were used to explore the objective. The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. The main outcome measures were the pooled relative risks (RR) per one conventional unit per mobility assessment for incident disability. A total of 40 reports (85,515 participants at baseline) were included. For usual and fast gait speed, the RR per -0.1 m/s was 1.23 (95% CI: 1.18-1.28; 26,638 participants) and 1.28 (95% CI: 1.19-1.38; 8161 participants), respectively. Each point decrease in Short Physical Performance Battery score increased the risk of incident disability by 30% (RR = 1.30, 95% CI: 1.23-1.38; 9183 participants). The RR of incident disability by each second increase in Timed Up and Go test and Chair Rise Test performance was 1.15 (95% CI: 1.09-1.21; 30,426 participants) and 1.07 (95% CI: 1.04-1.10; 9450 participants), respectively. The review concludes that among community-dwelling non-disabled older adults, poor mobility capacity is a potent modifiable risk factor for incident disability. Mobility impairment should be mandated as a quality indicator of health for older people.

Association of two geriatric treatment systems on care home admission and mortality in patients with hip fracture.

BACKGROUND: In Germany, geriatricians deliver acute geriatric care during an acute hospital stay and subacute rehabilitation after transfer to a rehabilitation clinic. However, the proportion of patients who receive acute geriatric care (AGC) or are transferred to subacute rehabilitation (TSR) differs considerably between hospitals. The aim of this study was to analyse the association between the two geriatric treatment systems and care home admission or mortality in patients following hip fracture. METHODS: Health insurance claims data were used to identify the rate of AGC per hospital and the rate of TSR per hospital following hip fracture surgery in patients aged ≥ 80 years. Outcomes were cumulative admission to a care home and cumulative mortality within 6 months after hospital admission. RESULTS: Data from 23,046 hip fracture patients from 561 hospitals were analysed. The rate of AGC was not associated with care home admission. However, compared to high rates of AGC medium rates or no AGC were associated with increased death rates by 12% or 20%, respectively. Treatment in hospitals with low rates of TSR was associated with a 8% higher risk of care home admission and a 10% increased risk of death compared to treatment in hospitals with high rates of TSR. CONCLUSIONS: Our study suggests potential effects of geriatric treatment: reduction of mortality in hospitals with high rates of AGC or reduction of care home admission and mortality in hospitals with high rates of TSR.

Effect of an osteoporotic fracture prevention program on fracture incidence in routine care: a cluster-randomized trial.

BACKGROUND: Fractures are a major health problem in aging societies. Preventive approaches combining bone health and fall prevention are rare. The osteoporotic fracture prevention program in rural areas (OFRA) is a health care fund-driven program for older people in randomly selected districts in Germany. The components of the program were falls prevention exercise classes, examination of bone health by a dual-energy X-ray absorptiometry (DXA) scan, and a consultation about "safety in the living environment." The aim of this study was to evaluate this complex preventive intervention in a routine health care setting. METHODS: This cluster-randomized trial was performed from October 2015 to October 2018 and took place in 186 administrative districts in five federal states, 47 districts served as intervention districts, and 139, as controls. Within these districts, we included (a) all community-living women and men aged 70-85 years with prior fragility fractures and (b) all community-living women aged 75-80 years. The analysis used routine data collected by a health insurance company. The primary endpoint was all fragility fractures combined. Fracture types, mortality, and nursing home admission were explorative endpoints. Cox frailty models were used for comparative analyses with a median follow-up time of 365 days (interquartile range: 0 days). RESULTS: Nine thousand four hundred eight individuals were approached to participate in one of the program components, 27,318 individuals served as controls. The mean age was 78.7 years. Of those approached to participate, nearly 30% joined the exercise classes. DXA measurement was reimbursed for 13.6%, and 51.8% received advice about measures to increase "safety in the living environment." The incidence of fragility fractures did not differ between the intervention and the control group (HR 0.94; 95% CI 0.80-1.11). However, femoral fractures, the most frequent fracture type, were reduced in the intervention group (HR 0.76; 95% CI 0.59-0.99). Mortality and nursing home admission did not differ between the intervention and the control group. CONCLUSIONS: A comprehensive fracture prevention program for older people living in rural areas was implemented. The program did not affect the primary endpoint of all fragility fractures combined. It has to be considered that we used a modified intention to treat approach based on geographic randomization and information about endpoints relied exclusively on routine data of the health care insurance. TRIAL REGISTRATION: German Clinical Trials Register DRKS-ID: 00009000.

A multifactorial interdisciplinary intervention to prevent functional and mobility decline for more participation in (pre-)frail community-dwelling older adults (PromeTheus): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Age-related decline in physical capacity can lead to frailty, associated with an increased vulnerability to adverse health outcomes and greater healthcare utilization. In an aging population, effective strategies to prevent physical decline and frailty, and preserve independence are needed. Prevention programs for vulnerable community-dwelling older adults are, however, often not yet established and implemented in routine practice. Research on the feasibility, implementation, and (cost-)effectiveness of multifactorial, interdisciplinary intervention programs that take advantage of available services of healthcare providers is also limited. The main aim of this study is to evaluate the effectiveness of such an intervention program (PromeTheus) to prevent functional and mobility decline for more participation in community-dwelling (pre-)frail older adults. METHODS: The study is designed as a three-center, randomized controlled trial with a 12-month intervention period. Four hundred community-dwelling (pre-)frail (Clinical Frailty Scale score 4-6) older adults (≥70 years) will be randomized in a 1:1 ratio to the intervention group (IG) or the control group (CG). The IG will receive the PromeTheus program consisting of obligatory home-based physical exercises (Weight-bearing Exercise for Better Balance) accompanied by physiotherapists and facultative counseling services (person-environment-fit, coping with everyday life, nutrition, group-based activities) delivered via existing healthcare structures (e.g., social workers, nutritionists). The CG will receive usual care and a one-time counseling session on recommendations for physical activity and nutrition. Primary outcomes assessed at months 6 and 12 are the function component of the Late-Life Function and Disability Instrument and the University of Alabama at Birmingham Life-Space Assessment. Secondary outcomes are disability, physical capacity and activity, frailty, nutritional status, falls, fear of falling, health status, and psychosocial components. Process and economic evaluations are also conducted. Primary statistical analyses will be based on the intention-to-treat principle. DISCUSSION: Compared to usual care, the PromeTheus program is expected to result in higher function and mobility, greater independence and lower need for care, and more participation. As the PromeTheus program draws on existing German healthcare structures, its large-scale translation and delivery will be feasible, if evidence of (cost-)effectiveness and successful implementation can be demonstrated. TRIAL REGISTRATION: German Clinical Trials Register, . Registered on March 11, 2021.

Gender-Specific Differences of Renal Heat Tolerance in Older Adults during Heat Waves.

BACKGROUND: Heat waves are known to cause increased morbidity and mortality in susceptible populations like old and functionally impaired people. The objective of the study was to assess renal tubular stress, a predictor for development of acute kidney injury, during heat waves in Central Europe. As a marker of renal tubular stress tissue inhibitor of metalloproteinases-2 [TIMP-2]·insulin-like growth factor binding protein-7 [IGFBP7], a new FDA-cleared renal tubular stress biomarker, was used. MATERIALS AND METHODS: 68 residents from facilities of sheltered housing with urine samples collected at heat waves in 2015 and at control visits were included. Urinary [TIMP-2]·[IGFBP7] was compared between the heat waves and the control visits. Multivariate linear models were adjusted for age, frailty index, and functional comorbidity index. RESULTS: The median age was 82.0 years, 82.3% were women. The percentage of elevated levels of urinary [TIMP-2]·[IGFBP7] (>0.3 [ng/mL]2/1,000) in the total study population was higher at the heat waves than at the control visits (25.0% vs. 17.7%). The effect of the heat waves on urinary [TIMP-2]·[IGFBP7] was stronger in men than in women: The percentage of elevated levels was 75.0% in men and 14.3% in women. In the multivariate analysis, the mean urinary [TIMP-2]·[IGFBP7] was 0.48 (95% CI 0.25; 0.70) (ng/mL)2/1,000 higher in men than in women. Except gender, a number of additional variables did not show an association with urinary [TIMP-2]·[IGFBP7] at the heat waves or the control visits. CONCLUSIONS: At heat waves, urinary [TIMP-2]·[IGFBP7] was elevated and higher in men than in women. This suggests gender-specific differences in renal heat tolerance in older people.

Health-economic evaluation of collaborative orthogeriatric care for patients with a hip fracture in Germany: a retrospective cohort study using health and long-term care insurance claims data.

BACKGROUND: Evidence suggests benefits of orthogeriatric co-management (OGCM) for hip fracture patients. Yet, evidence on cost-effectiveness is limited and based on small datasets. The aim of our study was to conduct an economic evaluation of the German OGCM for geriatric hip fracture patients. METHODS: This retrospective cohort study was based on German health and long-term care insurance data. Individuals were 80 years and older, sustained a hip fracture in 2014, and were treated in hospitals providing OGCM (OGCM group) or standard care (control group). Health care costs from payer and societal perspective, life years gained (LYG) and cost-effectiveness were investigated within 1 year. We applied weighted gamma and two-part models, and entropy balancing to account for the lack of randomisation. We calculated incremental cost-effectiveness ratios (ICER) and employed the net-benefit approach to construct cost-effectiveness acceptability curves. RESULTS: 14,005 patients were treated in OGCM, and 10,512 in standard care hospitals. Total average health care costs per patient were higher in the OGCM group: €1181.53 (p < 0.001) from payer perspective, and €1408.21 (p < 0.001) from societal perspective. The ICER equalled €52,378.12/ LYG from payer and €75,703.44/ LYG from societal perspective. The probability for cost-effectiveness would be 95% if the willingness-to-pay was higher than €82,000/ LYG from payer, and €95,000/ LYG from societal perspective. CONCLUSION: Survival improved in hospitals providing OGCM. Costs were found to increase, driven by inpatient and long-term care. The cost-effectiveness depends on the willingness-to-pay. The ICER is likely to improve with a longer follow-up.

Repeated Measurements of Cardiac Troponin T and N-Terminal Pro-B-Type Natriuretic Peptide to Assess Long-Term Mortality Risk in Subjects with Osteoarthritis.

Osteoarthritis (OA) is associated with higher cardiovascular mortality risk. High-sensitivity cardiac troponin T (hs-cTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) are well-characterized prognostic cardiac markers. We aimed to describe the changes in biomarkers measured one year apart in a cohort of 347 subjects with OA who underwent hip or knee replacement surgery in 1995/1996 and to analyze the prognostic value of repeated measurements for long-term mortality. During a median follow-up of 19 years, 209 (60.2%) subjects died. Substantial changes in cardiac biomarkers, especially for NT-proBNP, and an independent prognostic value of NT-proBNP for long-term mortality were found for both baseline measurement concentration (hazard ratio (HR) 1.32, 95% confidence interval (CI) (1.13-1.55)) and follow-up measurement concentration (HR 1.39, 95% CI 1.18-1.64) (all HR per standard deviation increase after natural log-transformation). Baseline concentrations were correlated with follow-up concentrations of NT-proBNP and no longer showed prognostic value when included simultaneously in a single model (HR 1.08, 95% CI 0.86-1.37), whereas the estimate for the one-year measurement remained robust (HR 1.31, 95% CI 1.04-1.66). Therefore, no significant additional benefit of repeated NT-proBNP measurements was found in this cohort, facilitating the use of a single NT-proBNP measurement as a stable prognostic marker.

Relieving distressed caregivers (ReDiCare study): study protocol of a randomized pragmatic trial.

BACKGROUND: Providing care for someone with a disease or chronic condition can have a negative psychological, physical, social, and economic impact upon informal caregivers. Despite the socio-economic relevance and more than three decades of caregiver intervention research only very few translational efforts of successful interventions are reported. Still less of these interventions have been implemented into routine services. The aim of the ReDiCare study (German acronym BerTA) is to evaluate the effectiveness of a stepped counselling approach for burdened caregivers delivered by care counsellors of two long-term care insurances and registered psychotherapists. METHODS/ DESIGN: A pragmatic randomised controlled trial with 572 caregivers of older adults (≥ 60 years) receiving benefits of one of the two participating long-term care insurances. Participants are assigned (t0) to either the ReDiCare intervention or a control group receiving routine care and counselling. Data are collected at baseline (-t1), 3-month (t1), 9-month (t2) and 15-month (t3). The 9-month post-intervention assessment (t2) is the primary endpoint to evaluate the results on the primary and secondary outcomes, measured by self-reported questionnaires. Depressive symptoms measured with the CES-D are the primary outcome. The main secondary outcomes are physical complaints, utilization of psychosocial resources, caregiver self-efficacy and burden, positive aspects of caregiving and perceived care quality. A process evaluation, including audio tapes, self-report questionnaires and documentation will be conducted to examine internal and external validity of the intervention. Data on direct and indirect costs are collected for the (health) economic evaluation, using a health care perspective and a societal perspective. DISCUSSION: While comparable previous caregiver interventions have been developed and evaluated for specific caregiver groups (e.g. dementia caregivers, stroke caregivers), the ReDiCare study will indicate whether a stepped approach will be effective also in a broader group of caregivers. The intervention is one of the very few translational studies in caregiver intervention research and will provide valuable insights into relevant factors for training, intervention protocol adherence, effectiveness, and costs for future implementation steps. TRIAL REGISTRATION: Deutsches Register Klinischer Studien (German Clinical Trials Register), DRKS00014593 ( www.drks.de,  registered 14 May 2018) and International Clinical Trials Registry Platform, DRKS00014593  ( https://apps.who.int/trialsearch/ ).

Psychometric properties of the German version of the Fear of Falling Questionnaire-revised (FFQ-R) in a sample of older adults after hip or pelvic fracture.

BACKGROUND: Identifying patients with maladaptive fear of falling (FOF) is important in the rehabilitation phase after serious fall. The 6-item Fear of Falling Questionnaire-revised (FFQ-R) was seen as promising measurement instrument as it evaluates FOF in a broader way than the one-item-question and independent of physical activities. AIM: The purpose of the analysis was to evaluate the psychometric properties of the translated German FFQ-R. METHODS: Back-translation method was applied. Confirmatory factor analysis (CFA) with diagonally weighted least square estimation was used to verify the two-factor structure. Data were collected during inpatient rehabilitation from hip and pelvic fracture patients [age 84.3 ± 6.2, Mini-Mental State Examination (MMSE) scores > 23] participating in an RCT (N = 112) and a cross-sectional survey (N = 40). RESULTS: Internal consistency was 0.78 (Cronbach´s alpha). No floor or ceiling effects were found. Discriminatory power on item level was moderate to good (r = 0.43-0.65). CFA revealed a good model fit and confirmed the two-factor structure. The German FFQ-R was moderately correlated (r = 0.51) with the Short Falls Efficacy Scale-International (Short FES-I) used as a proxy measure for FOF. Missing rates up to 9% for specific items were because some individuals, independent of cognitive level or age, had problems to rate items with conditional statements on possible negative consequences of a fall. CONCLUSIONS: Results demonstrated moderate to good psychometric properties similar to the original English version in a comparable sample of fracture patients.

German version of the outcome expectations for exercise scale-2 : Psychometric properties in geriatric patients after hip or pelvic fractures with fear of falling.

OBJECTIVE: Physical exercise is associated with many health benefits. Especially for older adults it is challenging to achieve an appropriate adherence to exercise programs. The outcome expectations for exercise scale 2 (OEE-2) is a 13-item self-report questionnaire to assess negative and positive exercise outcome expectations in older adults. The aim of this study was to translate the OEE­2 into German and to assess the psychometric properties of this version. METHODS: The OEE­2 was translated from English into German including a forward and backward translation process. Psychometric properties were assessed in 115 patients with hip/pelvic fractures (76% female, mean age 82.5 years) and fear of falling during geriatric inpatient rehabilitation. RESULTS: Principal component analyses could confirm a two-factor solution (positive/negative OEE) that explained 58% of the total variance, with an overall internal reliability of α = 0.89. Cronbach's α for the 9­item positive OEE subscale was 0.89, for the 4­item negative OEE subscale 0.79. The two subscales were correlated with rs = 0.49. Correlations of the OEE total score were highest with the perceived ability to manage falls, prefracture leisure time activities and prior training history (rs = 0.35-0.41). CONCLUSION: These results revealed good internal reliability and construct validity of the German version of the OEE­2. The instrument is valid for measuring physical exercise outcome expectations in older, German-speaking patients with hip or pelvic fractures and fear of falling.

Relationship between cardiac biomarker concentrations and long-term mortality in subjects with osteoarthritis.

Osteoarthritis (OA) is associated with adverse cardio-metabolic features. N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity troponins T and I (hs-cTnT and hs-cTnI) are well-characterized cardiac markers and provide prognostic information. The objective was to assess the association of cardiac biomarker concentrations with long-term mortality in subjects with OA. In a cohort of 679 OA subjects, undergoing hip or knee replacement during 1995/1996, cardiac biomarkers were measured and subjects were followed over 20 years. During a median follow-up of 18.4 years, 332 (48.9%) subjects died. Median of hs-cTnT, hs-cTnI, and NT-proBNP at baseline was 3.2 ng/L, 3.9 ng/L, and 96.8 ng/L. The top quartile of NT-proBNP was associated with increased risk of mortality (Hazard Ratio (HR) 1.79, 95% confidence interval (CI) 1.17-2.73) after adjustment for covariates including troponins (hs-cTnT HR 1.30 (95% CI 0.90-1.89), hs-cTnI HR 1.32 (95% CI 0.87-2.00) for top category). When biomarker associations were evaluated as continuous variables, only NT-proBNP (HR per log-unit increment 1.34, 95% CI 1.16-1.54) and hs-cTnI (HR 1.38, 95% CI 1.11-1.72) showed robust results. Elevated cardiac biomarker concentrations predicted an increased risk of long-term mortality and strongest for NT-proBNP and hs-cTnI. These results might help to identify subjects at risk and target preventive efforts early.

Five years' trajectories of functionality and pain in patients after hip or knee replacement and association with long-term patient survival.

To describe the 5 years' trajectories in functionality and pain of patients with hip or knee osteoarthritis and arthroplasty and analyze the association of these with long-term patients survival. Patients with OA receiving total hip or knee arthroplasty were recruited and completed two sets of standardized questionnaires for functionality and pain 6, 12, and 60 months postoperatively. Multivariate mixed models were conducted to assess trajectories over time and the resulting improvement per month during the last time period was included in a landmark-model to estimate adjusted hazard ratios for mortality. In total 809 patients with joint replacement were included (mean age 65.0 years, 62.2% female), 407 patients died (median follow-up 18.4 years). Both instruments of functionality and pain showed extensive improvement during the first 6 months. Baseline and change in functionality (both p < 0.001) and pain (p = 0.02) during the first 6 months were associated with mortality. Better values in functionality corresponded with improved survival whereas the association with the pain scores was inverse. In patients with hip and knee OA, an explicit improvement in function is seen within the first 6 months after arthroplasty. In addition, especially the functionality scores at baseline as well as their improvement showed an association with long-term patient survival.

Growth Differentiation Factor-15 as a Potent Predictor of Long-Term Mortality among Subjects with Osteoarthritis.

BACKGROUND: Subjects with osteoarthritis (OA) are at increased risk for cardiovascular (CV) and all-cause mortality. Whether biomarkers improve outcome prediction in these patients remains to be elucidated. We investigated the association between growth differentiation factor 15 (GDF-15), a novel stress-responsive cytokine, and long-term all-cause mortality among OA patients. METHODS: Within the Ulm Osteoarthritis Study, GDF-15 has been measured in the serum of 636 subjects, who underwent hip or knee arthroplasty between 1995 and 1996 (median age 65 years). RESULTS: During a median follow-up of 19.7 years, a total of 402 deaths occurred. GDF-15 was inversely associated with walking distance. Compared to the bottom quartile (Q), subjects within the top quartile of GDF-15 demonstrated a 2.69-fold increased risk of dying (hazard ratio (HR) (95% confidence interval (CI)) 2.69 (1.82-3.96) adjusted for age, sex, BMI, smoking status, localization of OA, diabetes, maximum walking distance, total cholesterol, and cystatin C. Further adjustment for NT-proBNP, troponin I, and hs-C-reactive protein did not change the results appreciably (HR (95%CI) 1.56 (1.07-2.28); 1.75 (1.21-2.55); 2.32 (1.55-3.47) for Q2, Q3, and Q4 respectively, p for trend < 0.001). CONCLUSIONS: In subjects with OA, GDF-15 represents a potent predictor of decreased survival over >20 years, independently of conventional CV risk factors, renal, cardiac, and inflammatory biomarkers as well as walking disability, previously associated with increased mortality and lower extremity OA.