Cardiac Rehabilitation in German Speaking Countries of Europe-Evidence-Based Guidelines from Germany, Austria and Switzerland LLKardReha-DACH-Part 2.

BACKGROUND: Scientific guidelines have been developed to update and harmonize exercise based cardiac rehabilitation (ebCR) in German speaking countries. Key recommendations for ebCR indications have recently been published in part 1 of this journal. The present part 2 updates the evidence with respect to contents and delivery of ebCR in clinical practice, focusing on exercise training (ET), psychological interventions (PI), patient education (PE). In addition, special patients' groups and new developments, such as telemedical (Tele) or home-based ebCR, are discussed as well. METHODS: Generation of evidence and search of literature have been described in part 1. RESULTS: Well documented evidence confirms the prognostic significance of ET in patients with coronary artery disease. Positive clinical effects of ET are described in patients with congestive heart failure, heart valve surgery or intervention, adults with congenital heart disease, and peripheral arterial disease. Specific recommendations for risk stratification and adequate exercise prescription for continuous-, interval-, and strength training are given in detail. PI when added to ebCR did not show significant positive effects in general. There was a positive trend towards reduction in depressive symptoms for "distress management" and "lifestyle changes". PE is able to increase patients' knowledge and motivation, as well as behavior changes, regarding physical activity, dietary habits, and smoking cessation. The evidence for distinct ebCR programs in special patients' groups is less clear. Studies on Tele-CR predominantly included low-risk patients. Hence, it is questionable, whether clinical results derived from studies in conventional ebCR may be transferred to Tele-CR. CONCLUSIONS: ET is the cornerstone of ebCR. Additional PI should be included, adjusted to the needs of the individual patient. PE is able to promote patients self-management, empowerment, and motivation. Diversity-sensitive structures should be established to interact with the needs of special patient groups and gender issues. Tele-CR should be further investigated as a valuable tool to implement ebCR more widely and effectively.

Cardiac Rehabilitation in German Speaking Countries of Europe-Evidence-Based Guidelines from Germany, Austria and Switzerland LLKardReha-DACH-Part 1.

BACKGROUND: Although cardiovascular rehabilitation (CR) is well accepted in general, CR-attendance and delivery still considerably vary between the European countries. Moreover, clinical and prognostic effects of CR are not well established for a variety of cardiovascular diseases. METHODS: The guidelines address all aspects of CR including indications, contents and delivery. By processing the guidelines, every step was externally supervised and moderated by independent members of the "Association of the Scientific Medical Societies in Germany" (AWMF). Four meta-analyses were performed to evaluate the prognostic effect of CR after acute coronary syndrome (ACS), after coronary bypass grafting (CABG), in patients with severe chronic systolic heart failure (HFrEF), and to define the effect of psychological interventions during CR. All other indications for CR-delivery were based on a predefined semi-structured literature search and recommendations were established by a formal consenting process including all medical societies involved in guideline generation. RESULTS: Multidisciplinary CR is associated with a significant reduction in all-cause mortality in patients after ACS and after CABG, whereas HFrEF-patients (left ventricular ejection fraction <40%) especially benefit in terms of exercise capacity and health-related quality of life. Patients with other cardiovascular diseases also benefit from CR-participation, but the scientific evidence is less clear. There is increasing evidence that the beneficial effect of CR strongly depends on "treatment intensity" including medical supervision, treatment of cardiovascular risk factors, information and education, and a minimum of individually adapted exercise volume. Additional psychologic interventions should be performed on the basis of individual needs. CONCLUSIONS: These guidelines reinforce the substantial benefit of CR in specific clinical indications, but also describe remaining deficits in CR-delivery in clinical practice as well as in CR-science with respect to methodology and presentation.

Performance Measures for Short-Term Cardiac Rehabilitation in Patients of Working Age: Results of the Prospective Observational Multicenter Registry OutCaRe.

OBJECTIVE: To determine immediate performance measures for short-term, multicomponent cardiac rehabilitation (CR) in clinical routine in patients of working age, taking into account cardiovascular risk factors, physical performance, social medicine, and subjective health parameters and to explore the underlying dimensionality. DESIGN: Prospective observational multicenter register study in 12 rehabilitation centers throughout Germany. SETTING: Comprehensive 3-week CR. PARTICIPANTS: Patients (N=1586) ≤65 years of age (mean 53.8±7.3y, 77.1% men) in CR (May 2017-May 2018). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Feasibility, defined by data availability for ≥85% of patients (CR admission and discharge), and modifiability based on pre-post comparison (statistical significance, with P value<.01; standardized effect size≥.35; change by ≥5% points in categorical variables). In addition, latent factors were identified using an exploratory factor analysis (EFA). RESULTS: Based on feasibility and modifiability criteria, smoking behavior, lifestyle change behavior, blood pressure, endurance training load, depression in Patient Health Questionnaire-9 (PHQ-9), the 5-item World Health Organization Well-Being Index (WHO-5), physical and mental health and pain scale of the indicators of rehabilitation status-24 (IRES-24), and self-assessed health prognosis proved to be suitable performance measures. As a result of the EFA, 2 solid factors were identified: (1) subjective mental health including PHQ-9, WHO-5, mental health (IRES-24), mental quality of life, and anxiety and (2) physical health including physical quality of life, physical health and pain scale of IRES-24, and self-assessed occupational prognosis. A third factor represents the blood pressure. CONCLUSIONS: We provide a small set of performance measures, that are essentially based on 3 latent factors (subjective mental health, physical health, blood pressure). These performance measures can represent immediate success of comprehensive CR and be applied easily in clinical practice.

[Cardiac Rehabilitation in Patients with Mechanical Circulatory Support]. / Mechanische Herzunterstützungssysteme in der kardiologischen Rehabilitation.

Background Heart failure in a terminal stage is usually treated with a heart transplant or with implantation of ventricular assist devices (VAD). VAD treatment is increasingly chosen as a permanent therapy. Problem The growing number of VAD implants leads to an increased need for rehabilitation programs. The development of standards is essential. So far only a few single center reports with a limited number of patients have been published. Guidelines on this subject are not available. Results A working group of German rehabilitation physicians was installed in order to analyze the problems and to develop strategies for the process of rehabilitation of VAD-patients, ending in a consensus statement 1.The most important aspects of rehabilitation aiming at the safest possible participation in everyday life with a VAD are summarized here.

The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation.

OBJECTIVE: To evaluate a patient-centred self-management educational group program for patients with chronic systolic heart failure as compared to usual care education during inpatient cardiac rehabilitation. METHODS: A multicentre cluster randomized controlled trial of 475 patients was conducted. In the intervention condition, patients received the new self-management educational group program whereas in the control condition, patients received a short lecture-based educational program (usual care). The primary outcome was patients' self-reported self-management competence. Secondary outcomes included self-management health behaviour, health-related quality of life, and treatment satisfaction. Patients completed self-reported outcome measures at admission, discharge, and after 6 and 12 months. RESULTS: There was a significant small between-group intervention effect on certain dimension of patients' self-management competence (self-monitoring and insight) in short term (p<0.05). Furthermore, significant small effects were observed for treatment satisfaction at discharge as well as symptom monitoring after 6 months (p<0.05) and by trend on symptom monitoring and physical activity after 12 months. CONCLUSIONS: The patient-centred self-management program might be more effective in certain self-management outcomes than a usual care education in both short-term and long-term periods. PRACTICE IMPLICATIONS: Therefore, such programs may be considered for dissemination within cardiac rehabilitation.

[Patient education in heart failure improves disease-related knowledge and behavior during cardiac rehabilitation]. / Patientenschulung bei Herzinsuffizienz verbessert krankheitsbezogenes Wissen und Verhalten während kardiologischer Rehabilitation.

INTRODUCTION: Heart failure is one of the most common und costly chronic diseases. Patient education is an important part of heart failure therapy. Rehabilitation aims to improve self-management abilities and the course of the disease. A structured heart failure education program was established to create knowledge about the disease and to implement a disease friendly behavior. The effectiveness was tested in a randomized controlled design. METHODS: Patients were cluster randomized -assigned to an intervention group or a control group at the beginning of a rehabilitation. Both received a rehabilitation specifically geared to heart-failure-patients. The intervention group received additionally the education program, the control group a single lecture on the disease. At the end of rehabilitation and 6 months later the knowledge and integrity of the recommended self-tests have been checked. In addition the disease severity and pharmacotherapy were determined. RESULTS: Both groups showed improvements in disease status. Participants of the education program had a sustained higher knowledge, were better adjusted to medication after 6 months and documented their self-tests more frequently. DISCUSSION: Regardless to the education intervention an improvement of the disease status occurs during cardiac rehabilitation. The effective single components are still unclear. The evaluated education program leads specifically to an improved disease-related knowledge and improved self-management skills. Due to these results it seems useful to include cardiac rehabilitation in heart failure disease-management programs - a specific heart failure education program should be integrated.

Heart-related anxieties in relation to general anxiety and severity of illness in cardiology patients.

Absence of an adequate reason for anxiety is a criterion for pathological anxiety. However, the presence of danger or fear-provoking stimuli may even be a risk factor for anxiety and does not exclude that there is additionally pathological anxiety too. The question is, to what degree can heart-related anxiety be explained by the severity of illness or trait anxiety? Two hundred and nine patients (37.8% women) from a cardiology inpatient unit completed the Heart-Anxiety-Questionnaire, Progression-Anxiety-Questionnaire, Job-Anxiety-Scale and the State-Trait-Anxiety-Inventory. The severity of cardiac illness was rated by the treating cardiologists using the Multidimensional Severity of Morbidity Rating. Time absent from work due to sickness was assessed as an indicator for illness-related impairment. Heart anxiety was significantly related to progression anxiety and, to a lesser extent, trait anxiety and indicators of subjective symptoms of somatic illness. No association was found with medical ratings for prognosis, multimorbidity, or reduction in life expectancy. Heart-related anxiety is a symptom of an anxiety disorder. Although partially dependent on subjective suffering, it cannot be explained by the severity of medical illness. Treatment of health-related anxieties should focus on how to cope with subjective symptoms of illness.

Evaluation of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation: study protocol of a cluster randomized controlled trial.

BACKGROUND: Chronic heart failure requires a complex treatment regimen on a life-long basis. Therefore, self-care/self-management is an essential part of successful treatment and comprehensive patient education is warranted. However, specific information on program features and educational strategies enhancing treatment success is lacking. This trial aims to evaluate a patient-oriented and theory-based self-management educational group program as compared to usual care education during inpatient cardiac rehabilitation in Germany. METHODS/DESIGN: The study is a multicenter cluster randomized controlled trial in four cardiac rehabilitation clinics. Clusters are patient education groups that comprise HF patients recruited within 2 weeks after commencement of inpatient cardiac rehabilitation. Cluster randomization was chosen for pragmatic reasons, i.e. to ensure a sufficient number of eligible patients to build large-enough educational groups and to prevent contamination by interaction of patients from different treatment allocations during rehabilitation. Rehabilitants with chronic systolic heart failure (n = 540) will be consecutively recruited for the study at the beginning of inpatient rehabilitation. Data will be assessed at admission, at discharge and after 6 and 12 months using patient questionnaires. In the intervention condition, patients receive the new patient-oriented self-management educational program, whereas in the control condition, patients receive a short lecture-based educational program (usual care). The primary outcome is patients' self-reported self-management competence. Secondary outcomes include behavioral determinants and self-management health behavior (symptom monitoring, physical activity, medication adherence), health-related quality of life, and treatment satisfaction. Treatment effects will be evaluated separately for each follow-up time point using multilevel regression analysis, and adjusting for baseline values. DISCUSSION: This study evaluates the effectiveness of a comprehensive self-management educational program by a cluster randomized trial within inpatient cardiac rehabilitation in Germany. Furthermore, subgroup-related treatment effects will be explored. Study results will contribute to a better understanding of both the effectiveness and mechanisms of a self-management group program as part of cardiac rehabilitation. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00004841; WHO International Clinical Trials: = DRKS00004841.

Self management of oral anticoagulation with the IN Ratio system: impact of a structured teaching program on patient's knowledge of medical background and procedures.

BACKGROUND: Self management of oral anticoagulation (OAC) decreases complication rates and improves quality of life. Manual and cognitive abilities of patients and patient training in a structured format are a precondition for this concept. Up to now, there is no evidence about knowledge increase from teaching programs. METHODS: Seventy-six patients (mean age, 57.4 years, 71% male) who started long-term OAC were included in the prospective multi-center study at three teaching centers representing different populations of anticoagulation patients: a department of cardiovascular surgery, an inpatient rehabilitation center and an anticoagulation clinic. The patients were trained in a structured education program for two days. For the evaluation, the patients performed standardized tests including 16 questions prior to start (T0), after each training unit (T1/T2) and 6 weeks later (T3). The primary endpoint was the percentage of > or =75% of patients who could answer > or =50% of questions correctly at T3. Secondary endpoints were the overall and item-specific percentages of correct answers at the end of each training unit (T1, T2) and at T3. In addition, the teaching program was rated by the patients on a six-point rating scale. RESULTS: Seventy-four out of 76 patients gave at least 50% correct answers at T3 (97.4%; 95% confidence interval, 90.8-99.7%). The average rates of correct answers developed from 40% (T0), 86% (T1), 94% (T2) to 96% (T3). The greatest increase of knowledge was observed with blood components, interpretation of International Normalized Ratio (INR) value, and the interaction of anticoagulation with other variables (e.g. drugs or infection). Patients rated the teaching program between 1 (best rating) and 2 at all time points. At T3, the patients reported less fear of complications and less limitations in their daily life than in earlier evaluations. CONCLUSION: The structured training program INRatio appears to be an appropriate instrument for instruction of INR self management. In comparison with baseline knowledge, the percentage of correctly answered questions was twice as high directly after the end of training and remained at a high level of >90% for at least 6 weeks.