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Abstract The objective was to evaluate the effectiveness of a self-management patient education programme for fibromyalgia syndrome (FMS) as compared with usual care education in inpatient rehabilitation. In a multicentre cluster-randomized controlled trial, 583 inpatients in 3 rehabilitation centres received an advanced self-management patient education programme or usual care education. Patients completed questionnaires at admission, discharge and after 6 and 12 months. Primary outcomes were disease- and treatment-specific knowledge at discharge, and self-management-competencies after 6 months. Secondary outcomes included satisfaction, attitudes, coping competencies, psychological distress and health impairment. We found a medium-sized effect on disease- and treatment-specific knowledge at discharge (P < 0.05, Cohen’s d = 0.45, 95% CI = 0.27–0.63), and small effects for subjective knowledge, pain-related control, self-monitoring and insight, communication about disease, action planning for physical activity and treatment satisfaction (all P < 0.05). Only the effect on knowledge persisted for 6 and 12 months. This advanced education programme seemed to be more effective in the short term than usual education. However, intermediate- and long-term effects did not emerge. While superior long-term effects on knowledge as well as short-term effects on self-management skills may suggest implementation, additional long-term effects on other patient-relevant outcomes would be desirable. Trial registration: German Clinical Trials Register, DRKS00008782, Registered 8 July 2015.

Purpose To assess stable effects of self-management programs, measurement instruments should primarily capture the attributes of interest, for example, the self-management skills of the measured persons. However, measurements of psychological constructs are always influenced by both aspects of the situation (states) and aspects of the person (traits). This study tests whether the Health Education Impact Questionnaire (heiQ™), an instrument assessing a wide range of proximal outcomes of self-management programs, is primarily influenced by person factors instead of situational factors. Furthermore, measurement invariance over time, changes in traits and predictors of change for each heiQ™ scale were examined. Methods Subjects were N = 580 patients with rheumatism, asthma, orthopedic conditions or inflammatory bowel disease, who filled out the heiQ™ at the beginning, the end of and 3 months after a disease-specific inpatient rehabilitation program in Germany. Structural equation modeling techniques were used to estimate latent trait-change models and test for measurement invariance in each heiQ™ scale. Coefficients of consistency, occasion specificity and reliability were computed. Results All scales showed scalar invariance over time. Reliability coefficients were high (0.80–0.94), and consistency coefficients (0.49–0.79) were always substantially higher than occasion specificity coefficients (0.14–0.38), indicating that the heiQ™ scales primarily capture person factors. Trait-changes with small to medium effect sizes were shown in five scales and were affected by sex, age and diagnostic group. Conclusion The heiQ™ can be used to assess stable effects in important outcomes of self-management programs over time, e.g., changes in self-management skills or emotional well-being.

Patient education in rheumatology should be evidence-based. As recommended by the European League Against Rheumatism (EULAR) the outcomes of evaluation studies should be based on the goals of the education program. In Germany the goals of education programs have been described for all relevant rheumatological indications, various education programs have been published and evaluated. Our model of patient education outcomes distinguishes proximal and distal outcomes that should be used in effectiveness studies. Proximal goals include health literacy (e.g. knowledge, skills, attitudes and motivation) and empowerment. These can be directly influenced by the educational elements of a program. Distal outcomes include self-management behavior (e.g. health behavior, adherence, coping and emotion regulation), morbidity, functioning, quality of life and participation. The latter can be influenced by proximal outcomes and moderated by a number of personal and environmental factors. The results of a literature search summarize appropriate measurements for these outcomes. For distal outcomes, valid instruments exist in the German language for some rheumatological indications. To assess proximal goals there are still developmental needs. We recommend choosing proximal and distal outcomes for evaluation according to the model of patient education outcomes and to test the relationships between these outcomes.

Zusammenfassung Patientenschulungen in der Rheumatologie sollten evidenzbasiert sein. Laut Empfehlungen der European League Against Rheumatism (EULAR) sollten sich die Zielgrößen der Evaluation an den Zielen der jeweiligen Schulung orientieren. In Deutschland wurden für alle relevanten rheumatologischen Indikationen Schulungsziele beschrieben, Schulungsprogramme publiziert und evaluiert. Zur Wirksamkeitsprüfung sollten proximale und distale Zielgrößen herangezogen werden, die in unserem „Wirkmodell der Patientenschulung“ dargestellt werden. Proximale Zielgrößen sind Gesundheitskompetenzen (Wissen, Fertigkeiten, Einstellungen, Motivation) und Empowerment. Diese können direkt durch die Schulungselemente beeinflusst werden. Distale Zielgrößen sind Selbstmanagement (Gesundheitsverhalten, Adhärenz, Krankheitsbewältigung, Emotionsregulation), Morbidität, Funktionsfähigkeit, Lebensqualität und Teilhabe. Letztere werden durch proximale Zielgrößen und eine Reihe von person- und umweltbezogenen Faktoren beeinflusst. Ergebnisse einer Literaturrecherche fassen geeignete Messinstrumente zur Erfassung dieser Zielgrößen zusammen. Für distale Zielgrößen gibt es für einige rheumatologische Indikationen valide Fragebogeninstrumente in deutscher Sprache. Zur Erfassung proximaler Zielgrößen gibt es noch Entwicklungsbedarf. Wir empfehlen, bei der Evaluation von Patientenschulungen proximale und distale Zielgrößen nach dem Wirkmodell auszuwählen und die Wirkzusammenhänge zwischen den Zielgrößen zu überprüfen.

Background Heart failure (HF) patient education aims to foster patients’ self-management skills. These are assumed to bring about, in turn, improvements in distal outcomes such as quality of life. The purpose of this study was to test the hypothesis that change in self-reported self-management skills observed after participation in self-management education predicts changes in physical and mental quality of life and depressive symptoms up to one year thereafter. Methods The sample comprised 342 patients with chronic heart failure, treated in inpatient rehabilitation clinics, who received a heart failure self-management education program. Latent change modelling was used to analyze relationships between both short-term (during inpatient rehabilitation) and intermediate-term (after six months) changes in self-reported self-management skills and both intermediate-term and long-term (after twelve months) changes in physical and mental quality of life and depressive symptoms. Results Short-term changes in self-reported self-management skills predicted intermediate-term changes in mental quality of life and long-term changes in physical quality of life. Intermediate-term changes in self-reported self-management skills predicted long-term changes in all outcomes. Conclusions These findings support the assumption that improvements in self-management skills may foster improvements in distal outcomes.

Background Fibromyalgia syndrome (FMS) is a complex chronic condition that makes high demands on patients’ self-management skills. Thus, patient education is considered an important component of multimodal therapy, although evidence regarding its effectiveness is scarce. The main objective of this study is to assess the effectiveness of an advanced self-management patient education program for patients with FMS as compared to usual care in the context of inpatient rehabilitation. Methods/Design We conducted a multicenter cluster randomized controlled trial in 3 rehabilitation clinics. Clusters are groups of patients with FMS consecutively recruited within one week after admission. Patients of the intervention group receive the advanced multidisciplinary self-management patient education program (considering new knowledge on FMS, with a focus on transfer into everyday life), whereas patients in the control group receive standard patient education programs including information on FMS and coping with pain. A total of 566 patients are assessed at admission, at discharge and after 6 and 12 months, using patient reported questionnaires. Primary outcomes are patients’ disease- and treatment-specific knowledge at discharge and self-management skills after 6 months. Secondary outcomes include satisfaction, attitudes and coping competences, health-promoting behavior, psychological distress, health impairment and participation. Treatment effects between groups are evaluated using multilevel regression analysis adjusting for baseline values. Discussion The study evaluates the effectiveness of a self-management patient education program for patients with FMS in the context of inpatient rehabilitation in a cluster randomized trial. Study results will show whether self-management patient education is beneficial for this group of patients. Trial registration German Clinical Trials Register, DRKS00008782 , Registered 8 July 2015

The growing burden of chronic disease and the current nature of healthcare systems which are structurally ill-equipped to cater to the complex needs of patients with chronic conditions has led to governments and healthcare providers seeking alternative ways to improve patients own capacity to actively self-manage their chronic condition. In Australia, there has been a focus on patient education and self-management programs within the healthcare system to achieve this. These programs aim to empower patients through providing information and teaching skills and techniques to improve self-care and doctor-patient interaction with the ultimate goal of improving quality of life. Patient education and self-management programs have been supported through several national government initiatives and implemented within the healthcare setting. This paper describes the current position of patient education and self-management within the Australian healthcare system. It further describes a new collaboration project between an Australian and a German research team which aims at translating an assessment questionnaire used in Australia for the evaluation of self-management programs, the \"Health Education Impact Questionnaire\" (\"heiQ\"); this instrument is expected to be of significant use in the German rehabilitative system.

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

Zusammenfassung Chronische Krankheiten nehmen in der westlichen Welt stark zu und stellen die Gesundheitssysteme vor neue Herausforderungen. Im Zuge verstärkter Patientenorientierung sollen Strukturen zur Unterstützung von Selbstmanagement und Selbstverantwortung geschaffen werden, wobei effizienten Schulungsprogrammen eine wichtige Rolle zukommt. Im australischen Gesundheitssystem wurden bereits Strategien im Umgang mit chronischen Erkrankungen umgesetzt. Eine davon ist die „Sharing Health Care Initiative“, die seit 1999 die verschiedenen Selbstmanagementprogramme untersucht. Eine nationale Evaluation dieser Initiative hat Empfehlungen zur Optimierung und Implementierung von Selbstmanagementprogrammen ausgesprochen, die in die Entwicklung der „National Chronic Disease Strategy“ eingeflossen sind, in deren Rahmen umfangreiche finanzielle Mittel ausgeschüttet werden. Vor dem Hintergrund der als notwendig erachteten Einführung eines Qualitätssicherungssystems entwickelte die Universität Melbourne den „Health Education Impact Questionnaire“ (heiQ) zur Evaluation und Qualitätssicherung von Selbstmanagementprogrammen. Im Rahmen eines vom Bundesministerium für Bildung und Forschung (BMBF) geförderten Forschungsprojekts soll dieser nun auch in Deutschland eingesetzt werden.