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Background:
Endomyocardial biopsy is considered as the gold standard in patients with suspected myocarditis. We aimed to evaluate the impact of bioptic findings on prediction of successful return to work.
Methods:
In 1153 patients (48.9 ± 12.4 years, 66.2% male), who were hospitalized due to symptoms of left heart failure between 2005 and 2012, an endomyocardial biopsy was performed. Routine clinical and laboratory data, sociodemographic parameters, and noninvasive and invasive cardiac variables including endomyocardial biopsy were registered. Data were linked with return to work data from the German statutory pension insurance program and analyzed by Cox regression.
Results:
A total of 220 patients had a complete data set of hospital and insurance information. Three quarters of patients were virus-positive (54.2% parvovirus B19, other or mixed infection 16.7%). Mean invasive left ventricular ejection fraction was 47.1% ± 18.6% (left ventricular ejection fraction <45% in 46.3%). Return to work was achieved after a mean interval of 168.8 ± 347.7 days in 220 patients (after 6, 12, and 24 months in 61.3%, 72.2%, and 76.4%). In multivariate regression analysis, only age (per 10 years, hazard ratio, 1.27; 95% confidence interval, 1.10–1.46; p = 0.001) and left ventricular ejection fraction (per 5% increase, hazard ratio, 1.07; 95% confidence interval, 1.03–1.12; p = 0.002) were associated with increased, elevated work intensity (heavy vs light, congestive heart failure, 0.58; 95% confidence interval, 0.34–0.99; p < 0.049) with decreased probability of return to work. None of the endomyocardial biopsy–derived parameters was significantly associated with return to work in the total group as well as in the subgroup of patients with biopsy-proven myocarditis.
Conclusion:
Added to established predictors, bioptic data demonstrated no additional impact for return to work probability. Thus, socio-medical evaluation of patients with suspected myocarditis furthermore remains an individually oriented process based primarily on clinical and functional parameters.
Background:
Endomyocardial biopsy is considered as the gold standard in patients with suspected myocarditis. We aimed to evaluate the impact of bioptic findings on prediction of successful return to work.
Methods:
In 1153 patients (48.9 ± 12.4 years, 66.2% male), who were hospitalized due to symptoms of left heart failure between 2005 and 2012, an endomyocardial biopsy was performed. Routine clinical and laboratory data, sociodemographic parameters, and noninvasive and invasive cardiac variables including endomyocardial biopsy were registered. Data were linked with return to work data from the German statutory pension insurance program and analyzed by Cox regression.
Results:
A total of 220 patients had a complete data set of hospital and insurance information. Three quarters of patients were virus-positive (54.2% parvovirus B19, other or mixed infection 16.7%). Mean invasive left ventricular ejection fraction was 47.1% ± 18.6% (left ventricular ejection fraction <45% in 46.3%). Return to work was achieved after a mean interval of 168.8 ± 347.7 days in 220 patients (after 6, 12, and 24 months in 61.3%, 72.2%, and 76.4%). In multivariate regression analysis, only age (per 10 years, hazard ratio, 1.27; 95% confidence interval, 1.10–1.46; p = 0.001) and left ventricular ejection fraction (per 5% increase, hazard ratio, 1.07; 95% confidence interval, 1.03–1.12; p = 0.002) were associated with increased, elevated work intensity (heavy vs light, congestive heart failure, 0.58; 95% confidence interval, 0.34–0.99; p < 0.049) with decreased probability of return to work. None of the endomyocardial biopsy–derived parameters was significantly associated with return to work in the total group as well as in the subgroup of patients with biopsy-proven myocarditis.
Conclusion:
Added to established predictors, bioptic data demonstrated no additional impact for return to work probability. Thus, socio-medical evaluation of patients with suspected myocarditis furthermore remains an individually oriented process based primarily on clinical and functional parameters.
Background: Functional abdominal pain (FAP) is not only a highly prevalent disease but also poses a considerable burden on children and their families. Untreated, FAP is highly persistent until adulthood, also leading to an increased risk of psychiatric disorders. Intervention studies underscore the efficacy of cognitive behavioral treatment approaches but are limited in terms of sample size, long-term follow-up data, controls and inclusion of psychosocial outcome data.
Methods/Design: In a multicenter randomized controlled trial, 112 children aged 7 to 12 years who fulfill the Rome III criteria for FAP will be allocated to an established cognitive behavioral training program for children with FAP (n = 56) or to an active control group (focusing on age-appropriate information delivery; n = 56). Randomization occurs centrally, blockwise and is stratified by center. This study is performed in five pediatric gastroenterology outpatient departments. Observer-blind assessments of outcome variables take place four times: pre-, post-, 3- and 12-months post-treatment. Primary outcome is the course of pain intensity and frequency. Secondary endpoints are health-related quality of life, pain-related coping and cognitions, as well as selfefficacy.
Discussion: This confirmatory randomized controlled clinical trial evaluates the efficacy of a cognitive behavioral intervention for children with FAP. By applying an active control group, time and attention processes can be controlled, and long-term follow-up data over the course of one year can be explored.
Background: Functional abdominal pain (FAP) is not only a highly prevalent disease but also poses a considerable burden on children and their families. Untreated, FAP is highly persistent until adulthood, also leading to an increased risk of psychiatric disorders. Intervention studies underscore the efficacy of cognitive behavioral treatment approaches but are limited in terms of sample size, long-term follow-up data, controls and inclusion of psychosocial outcome data.
Methods/Design: In a multicenter randomized controlled trial, 112 children aged 7 to 12 years who fulfill the Rome III criteria for FAP will be allocated to an established cognitive behavioral training program for children with FAP (n = 56) or to an active control group (focusing on age-appropriate information delivery; n = 56). Randomization occurs centrally, blockwise and is stratified by center. This study is performed in five pediatric gastroenterology outpatient departments. Observer-blind assessments of outcome variables take place four times: pre-, post-, 3- and 12-months post-treatment. Primary outcome is the course of pain intensity and frequency. Secondary endpoints are health-related quality of life, pain-related coping and cognitions, as well as selfefficacy.
Discussion: This confirmatory randomized controlled clinical trial evaluates the efficacy of a cognitive behavioral intervention for children with FAP. By applying an active control group, time and attention processes can be controlled, and long-term follow-up data over the course of one year can be explored.
This study investigated the incidence of hypertensive target organ damage (TOD), control of cardiovascular risk factors, and the short-term prognosis in hypertensive patients under contemporary guideline-oriented therapy.
A total of 1,377 consecutive patients (mean age 58.2 +/- 9.9 years, 82.2 % male) with arterial hypertension were included in the ESTher (Endorganschaden, Therapie und Verlauf - target organ damage, therapy, and course) registry at 15 rehabilitation clinics within the framework of the National Genome Research Network. Cardiovascular risk factors, medication, comorbidities, and glomerular filtration rate (GFR) were assessed. Left ventricular hypertrophy (LVH), left ventricular mass (LVM), left ventricular mass index (LVMI), and left ventricular ejection fraction (LVEF) were determined by two-dimensional echocardiography. The mean follow-up was 513 +/- 159 days. Changes in continuous parameters were tested by the t test, changes in discrete characteristics are presented by means of transition tables and tested with the McNemar test.
The mean LVEF was 59.3 +/- 9.9 %, both mean LVM (238.6 +/- 101.5 g) and LVMI (54.0 +/- 23.6 g/m(2.7)) were increased while relative wall thickness (RWT, 0.46 +/- 0.18) indicated the presence of concentric LVH. Of the patients, 10.2 % displayed renal dysfunction (estimated GFR < 60 ml/min/1.73 m(2)). The 1.5-year overall mortality was 1.2 %. Compared with discharge, at follow-up the proportion of patients with blood pressure (BP) values < 140/90 mmHg decreased from 68.7 % to 55.0 % (p < 0.001) and with low-density lipoprotein (LDL) values < 100 mg/dl from 62.6 % to 38.1 % (p < 0.001). At follow-up significantly more patients displayed a GFR value of < 60 ml/min/1.73 m(2) (10.2 % vs. 16.0 %, p < 0.001).
A significant proportion of hypertensive rehabilitation participants displayed TOD including LVH and renal dysfunction. Even after stringent BP reduction, a considerable increase in nephropathy could be found after 18 months.
Background Heart failure (HF) is a complex, chronic condition that is associated with debilitating symptoms, all of which necessitate close follow-up by health care providers. Lack of disease monitoring may result in increased mortality and more frequent hospital readmissions for decompensated HF. Remote patient management (RPM) in this patient population may help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a manifestation of HF decompensation. Objective The objective of the present article is to describe the design of a new trial investigating the impact of RPM on unplanned cardiovascular hospitalisations and mortality in HF patients. Methods The TIM-HF2 trial is designed as a prospective, randomised, controlled, parallel group, open (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. Eligible patients with HF are randomised (1:1) to either RPM + usual care or to usual care only and are followed for 12 months. The primary outcome is the percentage of days lost due to unplanned cardiovascular hospitalisations or all-cause death. The main secondary outcomes are all-cause and cardiovascular mortality. Conclusion The TIM-HF2 trial will provide important prospective data on the potential beneficial effect of telemedical monitoring and RPM on unplanned cardiovascular hospitalisations and mortality in HF patients.
Background: Telerehabilitation can contribute to the maintenance of successful rehabilitation regardless of location and time. The aim of this study was to investigate a specific three-month interactive telerehabilitation routine regarding its effectiveness in assisting patients with physical functionality and with returning to work compared to typical aftercare.
Objective: The aim of the study was to investigate a specific three-month interactive telerehabilitation with regard to effectiveness in functioning and return to work compared to usual aftercare.
Methods: From August 2016 to December 2017, 111 patients (mean 54.9 years old; SD 6.8; 54.3% female) with hip or knee replacement were enrolled in the randomized controlled trial. At discharge from inpatient rehabilitation and after three months, their distance in the 6-minute walk test was assessed as the primary endpoint. Other functional parameters, including health related quality of life, pain, and time to return to work, were secondary endpoints.
Results: Patients in the intervention group performed telerehabilitation for an average of 55.0 minutes (SD 9.2) per week. Adherence was high, at over 75%, until the 7th week of the three-month intervention phase. Almost all the patients and therapists used the communication options. Both the intervention group (average difference 88.3 m; SD 57.7; P=.95) and the control group (average difference 79.6 m; SD 48.7; P=.95) increased their distance in the 6-minute-walk-test. Improvements in other functional parameters, as well as in quality of life and pain, were achieved in both groups. The higher proportion of working patients in the intervention group (64.6%; P=.01) versus the control group (46.2%) is of note.
Conclusions: The effect of the investigated telerehabilitation therapy in patients following knee or hip replacement was equivalent to the usual aftercare in terms of functional testing, quality of life, and pain. Since a significantly higher return-to-work rate could be achieved, this therapy might be a promising supplement to established aftercare.
Background: Telerehabilitation can contribute to the maintenance of successful rehabilitation regardless of location and time. The aim of this study was to investigate a specific three-month interactive telerehabilitation routine regarding its effectiveness in assisting patients with physical functionality and with returning to work compared to typical aftercare.
Objective: The aim of the study was to investigate a specific three-month interactive telerehabilitation with regard to effectiveness in functioning and return to work compared to usual aftercare.
Methods: From August 2016 to December 2017, 111 patients (mean 54.9 years old; SD 6.8; 54.3% female) with hip or knee replacement were enrolled in the randomized controlled trial. At discharge from inpatient rehabilitation and after three months, their distance in the 6-minute walk test was assessed as the primary endpoint. Other functional parameters, including health related quality of life, pain, and time to return to work, were secondary endpoints.
Results: Patients in the intervention group performed telerehabilitation for an average of 55.0 minutes (SD 9.2) per week. Adherence was high, at over 75%, until the 7th week of the three-month intervention phase. Almost all the patients and therapists used the communication options. Both the intervention group (average difference 88.3 m; SD 57.7; P=.95) and the control group (average difference 79.6 m; SD 48.7; P=.95) increased their distance in the 6-minute-walk-test. Improvements in other functional parameters, as well as in quality of life and pain, were achieved in both groups. The higher proportion of working patients in the intervention group (64.6%; P=.01) versus the control group (46.2%) is of note.
Conclusions: The effect of the investigated telerehabilitation therapy in patients following knee or hip replacement was equivalent to the usual aftercare in terms of functional testing, quality of life, and pain. Since a significantly higher return-to-work rate could be achieved, this therapy might be a promising supplement to established aftercare.
Introduction: Remote telemonitoring (RTM) for patients with chronic heart failure (HF) holds promise to improve prognosis and well-being beyond the standard of care (SoC). The CardioBBEAT trial assessed the health economic and clinical impact of an interactive bidirectional RTM system (Motiva(R)) versus SoC for patients with HF and a reduced ejection fraction (HFrEF), in Germany.Methods: This multicenter, randomized controlled trial enrolled 621 patients with HFrEF (mean age 63.0 +/- 11.5 years, 88% men). The primary endpoint was the integrated effect of the intervention on total costs and nonhospitalized days alive after 12 months, reported as incremental cost-effectiveness ratio (ICER). Costs (in keuro) were based on actual charges of patients' statutory health insurance. Among secondary outcome measures were mortality and disease-specific quality of life.Results: We found a neutral effect on nonhospitalized days alive (RTM mean 341 +/- 59 days, SoC 346 +/- 45 days; p = 0.298) associated with increased total costs (RTM 18.5 +/- 39.5 keuro, SoC 12.8 +/- 22.0 keuro; p = 0.046). This yielded an ICER of -1.15 keuro/day. RTM did not impact mortality risk. All quality of life scales were consistently and meaningfully improved in the RTM group at 12 months compared to SoC (all p < 0.01).Conclusions: The first 12 months of RTM were not cost-effective compared to SoC in patients with HFrEF, but associated with a relevant improvement in disease-specific quality of life. The balanced assessment of the potential benefit of RTM requires integration of both the societal and patient perspective.ClinTrials.gov (NCT02293252).
Background: Travel-related conditions have impact on the quality of oral anticoagulation therapy (OAT) with vitamin K-antagonists. No predictors for travel activity and for travel-associated haemorrhage or thromboembolic complications of patients on OAT are known.
Methods: A standardised questionnaire was sent to 2500 patients on long-term OAT in Austria, Switzerland and Germany. 997 questionnaires were received (responder rate 39.9%). Ordinal or logistic regression models with travel activity before and after onset of OAT or travel-associated haemorrhages and thromboembolic complications as outcome measures were applied.
Results: 43.4% changed travel habits since onset of OAT with 24.9% and 18.5% reporting decreased or increased travel activity, respectively. Long-distance worldwide before OAT or having suffered from thromboembolic complications was associated with reduced travel activity. Increased travel activity was associated with more intensive travel experience, increased duration of OAT, higher education, or performing patient self-management (PSM). Travel-associated haemorrhages or thromboennbolic complications were reported by 6.5% and 0.9% of the patients, respectively. Former thromboennbolic complications, former bleedings and PSM were significant predictors of travel-associated complications.
Conclusions: OAT also increases travel intensity. Specific medical advice prior travelling to prevent complications should be given especially to patients with former bleedings or thromboennbolic complications and to those performing PSM. (C) 2014 Elsevier Ltd. All rights reserved.